Digital Commons Network^™

Durability Of Original Monovalent Mrna Vaccine Effectiveness Against Covid-19 Omicron-Associated Hospitalization In Children And Adolescents - United States, 2021-2023., Laura D. Zambrano, Margaret M. Newhams, Regina M. Simeone, Amanda B. Payne, Michael Wu, Amber O. Orzel-Lockwood, Natasha B. Halasa, Jemima M. Calixte, Pia S. Pannaraj, Kanokporn Mongkolrattanothai, Julie A Boom, Leila C Sahni, Satoshi Kamidani, Kathleen Chiotos, Melissa A Cameron, Aline B Maddux, Katherine Irby, Jennifer E. Schuster, Elizabeth H. Mack, Austin Biggs, Bria M. Coates, Kelly N. Michelson, Katherine E. Bline, Ryan A. Nofziger, Hillary Crandall, Charlotte V. Hobbs, Shira J. Gertz, Sabrina M. Heidemann, Tamara T. Bradford, Tracie C. Walker, Stephanie P. Schwartz, Mary Allen Staat, Samina S. Bhumbra, Janet R. Hume, Michele Kong, Melissa S. Stockwell, Thomas J. Connors, Melissa L. Cullimore, Heidi R. Flori, Emily R. Levy, Natalie Z. Cvijanovich, Matt S. Zinter, Mia Maamari, Cindy Bowens, Danielle M. Zerr, Judith A. Guzman-Cottrill, Ivan Gonzalez, Angela P. Campbell, Adrienne G. Randolph, Overcoming Covid-19 Investigators

Manuscripts, Articles, Book Chapters and Other Papers

Pediatric COVID-19 vaccination is effective in preventing COVID-19-related hospitalization, but duration of protection of the original monovalent vaccine during SARS-CoV-2 Omicron predominance merits evaluation, particularly given low coverage with updated COVID-19 vaccines. During December 19, 2021-October 29, 2023, the Overcoming COVID-19 Network evaluated vaccine effectiveness (VE) of ≥2 original monovalent COVID-19 mRNA vaccine doses against COVID-19-related hospitalization and critical illness among U.S. children and adolescents aged 5-18 years, using a case-control design. Too few children and adolescents received bivalent or updated monovalent vaccines to separately evaluate their effectiveness. Most case-patients (persons with a positive SARS-CoV-2 test result) were unvaccinated, despite …

Antiviral Cellular Therapy For Enhancing T-Cell Reconstitution Before Or After Hematopoietic Stem Cell Transplantation (Aces): A Two-Arm, Open Label Phase Ii Interventional Trial Of Pediatric Patients With Risk Factor Assessment., Michael D. Keller, Patrick J. Hanley, Yueh-Yun Chi, Paibel Aguayo-Hiraldo, Christopher C. Dvorak, Michael R. Verneris, Donald B. Kohn, Sung-Yun Pai, Blachy J. Dávila Saldaña, Benjamin Hanisch, Troy C. Quigg, Roberta H. Adams, Ann Dahlberg, Shanmuganathan Chandrakasan, Hasibul Hasan, Jemily Malvar, Mariah A. Jensen-Wachspress, Christopher A. Lazarski, Gelina Sani, John M. Idso, Haili Lang, Pamela Chansky, Chase D. Mccann, Jay Tanna, Allistair A. Abraham, Jennifer L. Webb, Abeer Shibli, Amy K. Keating, Prakash Satwani, Pawel Muranski, Erin Hall, Michael J. Eckrich, Evan Shereck, Holly Miller, Ewelina Mamcarz, Rajni Agarwal, Satiro N. De Oliveira, Mark T. Vander Lugt, Christen L. Ebens, Victor M. Aquino, Jeffrey J. Bednarski, Julia Chu, Suhag Parikh, Jennifer Whangbo, Michail Lionakis, Elias T. Zambidis, Elizabeth Gourdine, Catherine M. Bollard, Michael A. Pulsipher

Manuscripts, Articles, Book Chapters and Other Papers

Viral infections remain a major risk in immunocompromised pediatric patients, and virus-specific T cell (VST) therapy has been successful for treatment of refractory viral infections in prior studies. We performed a phase II multicenter study (NCT03475212) for the treatment of pediatric patients with inborn errors of immunity and/or post allogeneic hematopoietic stem cell transplant with refractory viral infections using partially-HLA matched VSTs targeting cytomegalovirus, Epstein-Barr virus, or adenovirus. Primary endpoints were feasibility, safety, and clinical responses (>1 log reduction in viremia at 28 days). Secondary endpoints were reconstitution of antiviral immunity and persistence of the infused VSTs. Suitable VST …

Covid-19 Vaccination In Patients With Inborn Errors Of Immunity Reduces Hospitalization And Critical Care Needs Related To Covid-19: A Usidnet Report., John Mcdonnell, Kimberley Cousins, M Elizabeth M. Younger, Adam Lane, Hassan Abolhassani, Roshini S. Abraham, Salem Al-Tamemi, Juan Carlos Aldave-Becerra, Eman Hesham Al-Faris, Alberto Alfaro-Murillo, Suzan A. Alkhater, Nouf Alsaati, Alexa Michelle Altman Doss, Melissa Anderson, Ernestina Angarola, Barbara Ariue, Danielle E. Arnold, Amal H. Assa'ad, Caner Aytekin, Meaghan Bank, Jenna R E Bergerson, Jack Bleesing, John Boesing, Carolina Bouso, Nicholas Brodszki, Diana Cabanillas, Carol Cady, Meghan A. Callahan, Roberta Caorsi, Javier Carbone, Maria Carrabba, Riccardo Castagnoli, Jason R. Catanzaro, Samantha Chan, Sharat Chandra, Hugo Chapdelaine, Zahra Chavoshzadeh, Hey Jin Chong, Lori Connors, Filippo Consonni, Oscar Correa-Jimenez, Charlotte Cunningham-Rundles, Katherine D'Astous-Gauthier, Ottavia Maria Delmonte, Yesim Yilmaz Demirdag, Deepti R. Deshpande, Natalie M. Diaz-Cabrera, Victoria R. Dimitriades, Rasha El-Owaidy, Gehad Elghazali, Suleiman Al-Hammadi, Giovanna Fabio, Astrid Schellnast Faure, Jin Feng, James M. Fernandez, Lauren Fill, Guacira R. Franco, Robert W. Frenck, Ramsay L. Fuleihan, Giuliana Giardino, Jessica Galant-Swafford, Eleonora Gambineri, Elizabeth K. Garabedian, Ashley V. Geerlinks, Ekaterini Goudouris, Octavio Grecco, Qiang Pan-Hammarström, Hedieh Haji Khodaverdi Khani, Lennart Hammarström, Nicholas L. Hartog, Jennifer Heimall, Gabriela Hernandez-Molina, Caroline C. Horner, Robert W. Hostoffer, Nataliya Hristova, Kuang-Chih Hsiao, Gabriela Ivankovich-Escoto, Faris Jaber, Maaz Jalil, Mahnaz Jamee, Tiffany Jean, Stephanie Jeong, Devi Jhaveri, Michael B. Jordan, Avni Y. Joshi, Amanpreet Kalkat, Henry J. Kanarek, Erinn S. Kellner, Amer Khojah, Ruby Khoury, Cristina M. Kokron, Ashish Kumar, Kelsey Lecerf, Heather K. Lehman, Jennifer W. Leiding, Harry Lesmana, Xin Rong Lim, Joao Pedro Lopes, Ana Laura López, Lucia Tarquini, Ingrid S. Lundgren, Julieann Magnusson, Ana Karolina B B Marinho, Gian Luigi Marseglia, Giulia M. Martone, Annamaria G. Mechtler, Leonardo Mendonca, Joshua D. Milner, Peter J. Mustillo, Asal Gharib Naderi, Samuele Naviglio, Jeremy Nell, Hana B. Niebur, Luigi Notarangelo, Matias Oleastro, María Claudia Ortega-López, Neil R. Patel, Gordana Petrovic, Claudio Pignata, Oscar Porras, Benjamin T. Prince, Jennifer M. Puck, Nashmia Qamar, Marco Rabusin, Nikita Raje, Lorena Regairaz, Kimberly A. Risma, Elizabeth H. Ristagno, John Routes, Persio Roxo-Junior, Negin Salemi, Christopher Scalchunes, Susan J. Schuval, Suranjith L. Seneviratne, Ashwin Shankar, Roya Sherkat, Junghee Jenny Shin, Abeer Siddiqi, Sara Signa, Ali Sobh, Fabiana Mascarenhas Souza Lima, Kristen K. Stenehjem, Jonathan S. Tam, Monica Tang, Myrthes Toledo Barros, James Verbsky, Eleni Vergadi, Dayne H. Voelker, Stefano Volpi, Luke A. Wall, Christine Wang, Kelli W. Williams, Eveline Y. Wu, Shan Shan Wu, Jessie J. Zhou, Alexandria Cook, Kathleen E. Sullivan, Rebecca Marsh

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: The CDC and ACIP recommend COVID-19 vaccination for patients with inborn errors of immunity (IEI). Not much is known about vaccine safety in IEI, and whether vaccination attenuates infection severity in IEI.

OBJECTIVE: To estimate COVID-19 vaccination safety and examine effect on outcomes in patients with IEI.

METHODS: We built a secure registry database in conjunction with the US Immunodeficiency Network to examine vaccination frequency and indicators of safety and effectiveness in IEI patients. The registry opened on January 1, 2022, and closed on August 19, 2022.

RESULTS: Physicians entered data on 1245 patients from 24 countries. The most …

Diagnostic Stewardship To Improve Patient Outcomes And Healthcare-Associated Infection (Hai) Metrics., Harjot K. Singh, Kimberly C. Claeys, Sonali D. Advani, Yolanda Ballam, Jessica Penney, Kirsten M. Schutte, Christopher Baliga, Aaron M. Milstone, Mary K. Hayden, Daniel J. Morgan, Daniel J. Diekema

Manuscripts, Articles, Book Chapters and Other Papers

Diagnostic stewardship seeks to improve ordering, collection, performance, and reporting of tests. Test results play an important role in reportable HAIs. The inclusion of HAIs in public reporting and pay for performance programs has highlighted the value of diagnostic stewardship as part of infection prevention initiatives. Inappropriate testing should be discouraged, and approaches that seek to alter testing solely to impact a reportable metric should be avoided. HAI definitions should be further adapted to new testing technologies, with focus on actionable and clinically relevant test results that will improve patient care.

Accuracy Of Influenza Icd-10 Diagnosis Codes In Identifying Influenza Illness In Children., James W. Antoon, Tess Stopczynski, Justin Z. Amarin, Laura S. Stewart, Julie A. Boom, Leila C. Sahni, Marian G. Michaels, John V. Williams, Janet A. Englund, Eileen J. Klein, Mary A. Staat, Elizabeth P. Schlaudecker, Rangaraj Selvarangan, Jennifer E. Schuster, Geoffrey A. Weinberg, Peter G. Szilagyi, Ariana Perez, Heidi L. Moline, Andrew J. Spieker, Carlos G. Grijalva, Samantha M. Olson, Natasha B. Halasa

Manuscripts, Articles, Book Chapters and Other Papers

IMPORTANCE: Studies of influenza in children commonly rely on coded diagnoses, yet the ability of International Classification of Diseases, Ninth Revision codes to identify influenza in the emergency department (ED) and hospital is highly variable. The accuracy of newer International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes to identify influenza in children is unknown.

OBJECTIVE: To determine the accuracy of ICD-10 influenza discharge diagnosis codes in the pediatric ED and inpatient settings.

DESIGN, SETTING, AND PARTICIPANTS: Children younger than 18 years presenting to the ED or inpatient settings with fever and/or respiratory symptoms at 7 …

Early Estimate Of Nirsevimab Effectiveness For Prevention Of Respiratory Syncytial Virus-Associated Hospitalization Among Infants Entering Their First Respiratory Syncytial Virus Season - New Vaccine Surveillance Network, October 2023-February 2024., Heidi L. Moline, Ayzsa Tannis, Ariana P. Toepfer, John V. Williams, Julie A. Boom, Janet A. Englund, Natasha B. Halasa, Mary Allen Staat, Geoffrey A. Weinberg, Rangaraj Selvarangan, Marian G. Michaels, Leila C. Sahni, Eileen J. Klein, Laura S. Stewart, Elizabeth P. Schlaudecker, Peter G. Szilagyi, Jennifer E. Schuster, Leah Goldstein, Samar Musa, Pedro A. Piedra, Danielle M. Zerr, Kristina A. Betters, Chelsea Rohlfs, Christina Albertin, Dithi Banerjee, Erin R. Mckeever, Casey Kalman, Benjamin R. Clopper, New Vaccine Surveillance Network Product Effectiveness Collaborators, Meredith L. Mcmorrow, Fatimah S. Dawood

Manuscripts, Articles, Book Chapters and Other Papers

Respiratory syncytial virus (RSV) is the leading cause of hospitalization among infants in the United States. In August 2023, CDC's Advisory Committee on Immunization Practices recommended nirsevimab, a long-acting monoclonal antibody, for infants agedtrials, nirsevimab efficacy against RSV-associated lower respiratory tract infection with hospitalization was 81% (95% CI = 62%-90%) through 150 days after receipt; post-introduction effectiveness has not been assessed in the United States. In this analysis, the New Vaccine Surveillance Network evaluated nirsevimab effectiveness against RSV-associated hospitalization among infants in their first RSV season during October 1, 2023-February 29, 2024. Among 699 infants hospitalized with acute respiratory illness, …

Interim Estimates Of 2023-24 Seasonal Influenza Vaccine Effectiveness - United States., Aaron M. Frutos, Ashley M. Price, Elizabeth Harker, Emily L. Reeves, Haris M. Ahmad, Vel Murugan, Emily T. Martin, Stacey House, Elie A. Saade, Richard K. Zimmerman, Manjusha Gaglani, Karen J. Wernli, Emmanuel B. Walter, Marian G. Michaels, Mary A. Staat, Geoffrey A. Weinberg, Rangaraj Selvarangan, Julie A. Boom, Eileen J. Klein, Natasha B. Halasa, Adit A. Ginde, Kevin W. Gibbs, Yuwei Zhu, Wesley H. Self, Sara Y. Tartof, Nicola P. Klein, Kristin Dascomb, Malini B. Desilva, Zachary A. Weber, Duck-Hye Yang, Sarah W. Ball, Diya Surie, Jennifer Decuir, Fatimah S. Dawood, Heidi L. Moline, Ariana P. Toepfer, Benjamin R. Clopper, Ruth Link-Gelles, Amanda B. Payne, Jessie R. Chung, Brendan Flannery, Nathaniel M. Lewis, Samantha M. Olson, Katherine Adams, Mark W. Tenforde, Shikha Garg, Lisa A. Grohskopf, Carrie Reed, Sascha Ellington, Cdc Influenza Vaccine Effectiveness Collaborators

Manuscripts, Articles, Book Chapters and Other Papers

In the United States, annual influenza vaccination is recommended for all persons aged ≥6 months. Using data from four vaccine effectiveness (VE) networks during the 2023-24 influenza season, interim influenza VE was estimated among patients aged ≥6 months with acute respiratory illness-associated medical encounters using a test-negative case-control study design. Among children and adolescents aged 6 months-17 years, VE against influenza-associated outpatient visits ranged from 59% to 67% and against influenza-associated hospitalization ranged from 52% to 61%. Among adults aged ≥18 years, VE against influenza-associated outpatient visits ranged from 33% to 49% and against hospitalization from 41% to 44%. VE …

Notes From The Field: Reemergence Of Mycoplasma Pneumoniae Infections In Children And Adolescents After The Covid-19 Pandemic, United States, 2018-2024., Chris Edens, Benjamin R. Clopper, Jourdan Devies, Alvaro Benitez, Erin R. Mckeever, Dylan Johns, Bernard Wolff, Rangaraj Selvarangan, Jennifer E. Schuster, Geoffrey A. Weinberg, Peter G. Szilagyi, Fatimah S. Dawood, Lakshmi Radhakrishnan, Christina Quigley, Leila C. Sahni, Natasha Halasa, Laura S. Stewart, Meredith L. Mcmorrow, Brett Whitaker, Danielle M. Zerr, Vasanthi Avadhanula, John V. Williams, Marian G. Michaels, Aaron Kite-Powell, Janet A. Englund, Mary Allen Staat, Kathleen Hartnett, Heidi L. Moline, Adam L. Cohen, Maureen Diaz

Manuscripts, Articles, Book Chapters and Other Papers

No abstract provided.

Opportunities For Pharmacogenetic Testing To Guide Dosing Of Medications In Youths With Medicaid., Sonya Tang Girdwood, Matthew Hall, James W. Antoon, Kathryn Kyler, Derek J. Williams, Samir S. Shah, Lucas E. Orth, Jennifer Goldman, James A. Feinstein, Laura B. Ramsey

Manuscripts, Articles, Book Chapters and Other Papers

IMPORTANCE: There are an increasing number of medications with a high level of evidence for pharmacogenetic-guided dosing (PGx drugs). Knowledge of the prevalence of dispensings of PGx drugs and their associated genes may allow hospitals and clinical laboratories to determine which pharmacogenetic tests to implement.

OBJECTIVES: To investigate the prevalence of outpatient dispensings of PGx drugs among Medicaid-insured youths, determine genes most frequently associated with PGx drug dispenses, and describe characteristics of youths who were dispensed at least 1 PGx drug.

DESIGN, SETTING, AND PARTICIPANTS: This serial cross-sectional study includes data from 2011 to 2019 among youths aged 0 to …

The Durability Of Antibody Responses Of Two Doses Of High-Dose Relative To Two Doses Of Standard-Dose Inactivated Influenza Vaccine In Pediatric Hematopoietic Cell Transplant Recipients: A Multi-Center Randomized Controlled Trial., Jennifer E. Schuster, Lubna Hamdan, Daniel E. Dulek, Carrie L. Kitko, Einas Batarseh, Zaid Haddadin, Laura S. Stewart, Anna Stahl, Molly Potter, Herdi Rahman, Spyros A. Kalams, Claire E. Bocchini, Elizabeth A. Moulton, Susan E. Coffin, Monica I. Ardura, Rachel L. Wattier, Gabriela Maron, Michael Grimley, Grant Paulsen, Christopher J. Harrison, Jason L. Freedman, Paul A. Carpenter, Janet A. Englund, Flor M. Munoz, Lara Danziger-Isakov, Andrew J. Spieker, Natasha B. Halasa, Pediatric Hct Flu Study

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Our previous study established a 2-dose regimen of high-dose trivalent influenza vaccine (HD-TIV) to be immunogenically superior compared to a 2-dose regimen of standard-dose quadrivalent influenza vaccine (SD-QIV) in pediatric allogeneic hematopoietic cell transplant (HCT) recipients. However, the durability of immunogenicity and the role of time post-HCT at immunization as an effect modifier are unknown.

METHODS: This phase II, multi-center, double-blinded, randomized controlled trial compared HD-TIV to SD-QIV in children 3-17 years old who were 3-35 months post-allogeneic HCT, with each formulation administered twice, 28-42 days apart. Hemagglutination inhibition (HAI) titers were measured at baseline, 28-42 days following each …

Exploring Factors For Implementation Of Epas In Pediatric Subspecialty Fellowships: A Qualitative Study Of Program Directors., Angela S. Czaja, Richard B. Mink, Bruce E. Herman, Pnina Weiss, David A. Turner, Megan L. Curran, Diane E J Stafford, Angela Myers, Melissa L. Langhan

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVE: To understand fellowship program directors' (FPDs) perspectives on facilitators and barriers to using entrustable professional activities (EPAs) in pediatric subspecialty training.

METHODS: We performed a qualitative study of FPDs, balancing subspecialty, program size, geographic region and current uses of EPAs. A study coordinator conducted 1-on-1 interviews using a semistructured approach to explore EPA use or nonuse and factors supporting or preventing their use. Investigators independently coded transcribed interviews using an inductive approach and the constant comparative method. Group discussion informed code structure development and refinement. Iterative data collection and analysis continued until theoretical sufficiency was achieved, yielding a thematic …

Clarification Of Adverse Drug Reactions By A Pharmacovigilance Team Results In Increased Antibiotic Re-Prescribing At A Freestanding United States Children's Hospital., Keith Feldman, Sarah Suppes, Jennifer Goldman

Manuscripts, Articles, Book Chapters and Other Papers

Documentation of adverse drug reactions (ADRs) is a key factor in guiding future prescribing. However, incomplete documentation is common and often fails to distinguish implicated drugs as true allergies. This in turn leads to unnecessary avoidance of implicated drug classes and may result in sub-optimal prescribing. Pharmacovigilance (PV) programs utilize a systematic approach to clarify ADR documentation and are known to improve patient safety. Yet it remains unclear if PV alters prescribing. Or, if the existence of the ADR documentation itself continues to prompt avoidance of implicated drugs. To address this, our work presents a retrospective cohort study assessing if …

Assessing Covid-Related Concerns And Their Impact On Antenatal And Delivery Care Among Pregnant Women Living With Hiv In Kenya: A Brief Report., Catherine Wexler, May Maloba, Sharon Mokua, Shadrack Babu, Nicodemus Maosa, Vincent Staggs, Kathy Goggin, Harshdeep Acharya, Emily A. Hurley, Sarah Finocchario-Kessler

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Some studies indicate that pregnant Kenyan women were concerned about Coronavirus disease 2019 (COVID-19) exposure during maternity care. We assessed concern regarding COVID-19 exposure and any impact on antenatal care (ANC) enrollment and/or hospital delivery among pregnant women living with human immunodeficiency virus (HIV) in Kenya.

METHODS: Data were collected from 1,478 pregnant women living with HIV enrolled in prevention of mother to child transmission of HIV (PMTCT) care at 12 Kenyan hospitals from October 2020 to July 2022. Surveys were conducted when women first presented for PMTCT services at the study hospital and asked demographic questions as well …

The Challenges And Opportunities Of Offering And Integrating Training In Clinical Molecular Genetics And Clinical Cytogenetics: A Survey Of Lgg Fellowship Program Directors., Joshua L. Deignan, Vimla Aggarwal, Allen E. Bale, Daniel B. Bellissimo, Jessica K. Booker, Yang Cao, Kristy R. Crooks, Kristen L. Deak, Daniela Del Gaudio, Birgit Funke, Nicole L. Hoppman, Vanessa Horner, Robert B. Hufnagel, Colleen Jackson-Cook, Prasad Koduru, Marco L. Leung, Shibo Li, Pengfei Liu, Minjie Luo, Rong Mao, Heather Mason-Suares, Fady M. Mikhail, Stephen R. Moore, Rizwan C. Naeem, Laura M. Pollard, Elena Repnikova, Lina Shao, Brandon M. Shaw, Shashirekha Shetty, Teresa A. Smolarek, Elizabeth Spiteri, Jessica Van Ziffle, Gail H. Vance, Cindy L. Vnencak-Jones, Eli S. Williams

Manuscripts, Articles, Book Chapters and Other Papers

PURPOSE: The specialty of Laboratory Genetics and Genomics (LGG) was created in 2017 in an effort to reflect the increasing convergence in technologies and approaches between clinical molecular genetics and clinical cytogenetics. However, there has not yet been any formal evaluation of the merging of these disciplines and the challenges faced by Program Directors (PDs) tasked with ensuring the successful training of laboratory geneticists under the new model.

METHODS: An electronic multi-question Qualtrics survey was created and was sent to the PD for each of the Accreditation Council for Graduate Medical Education-accredited LGG fellowship programs at the time. The data …

Pcv15, A Pneumococcal Conjugate Vaccine, For The Prevention Of Invasive Pneumococcal Disease In Infants And Children., Timothy J. Chapman, Liset Olarte, Ghassan Dbaibo, Avril Melissa Houston, Gretchen Tamms, Robert Lupinacci, Kristen Feemster, Ulrike K. Buchwald, Natalie Banniettis

Manuscripts, Articles, Book Chapters and Other Papers

INTRODUCTION:

Streptococcus pneumoniae is a causative agent of pneumonia and acute otitis media (AOM), as well as invasive diseases such as meningitis and bacteremia. PCV15 (V114) is a new 15-valent pneumococcal conjugate vaccine (PCV) approved for use in individuals ≥6 weeks of age for the prevention of pneumonia, AOM, and invasive pneumococcal disease.

AREAS COVERED: This review summarizes the V114 Phase 3 development program leading to approval in infants and children, including pivotal studies, interchangeability and catch-up vaccination studies, and studies in at-risk populations. An integrated safety summary is presented in addition to immunogenicity and concomitant use of V114 with …

The Modified Clinical Progression Scale For Pediatric Patients: Evaluation As A Severity Metric And Outcome Measure In Severe Acute Viral Respiratory Illness., Shannon B. Leland, Steven J. Staffa, Margaret M. Newhams, Robinder G. Khemani, John C. Marshall, Cameron C. Young, Aline B. Maddux, Mark W. Hall, Scott L. Weiss, Adam J. Schwarz, Bria M. Coates, Ronald C. Sanders, Michele Kong, Neal J. Thomas, Ryan A. Nofziger, Melissa L. Cullimore, Natasha B. Halasa, Laura L. Loftis, Natalie Z. Cvijanovich, Jennifer E. Schuster, Heidi Flori, Shira J. Gertz, Janet R. Hume, Samantha M. Olson, Manish M. Patel, David Zurakowski, Adrienne G. Randolph, Pediatric Acute Lung And Sepsis Investigator’S Network Pediatric Intensive Care Influenza Study Group (Palisi Picflu) Investigators And Overcoming Covid-19 Investigators

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVES: To develop, evaluate, and explore the use of a pediatric ordinal score as a potential clinical trial outcome metric in children hospitalized with acute hypoxic respiratory failure caused by viral respiratory infections.

DESIGN: We modified the World Health Organization Clinical Progression Scale for pediatric patients (CPS-Ped) and assigned CPS-Ped at admission, days 2-4, 7, and 14. We identified predictors of clinical improvement (day 14 CPS-Ped ≤ 2 or a three-point decrease) using competing risks regression and compared clinical improvement to hospital length of stay (LOS) and ventilator-free days. We estimated sample sizes (80% power) to detect a 15% clinical …

Sars-Cov-2 Epidemiology And Covid-19 Mrna Vaccine Effectiveness Among Infants And Children Aged 6 Months-4 Years - New Vaccine Surveillance Network, United States, July 2022-September 2023., Ayzsa Tannis, Janet A. Englund, Ariana Perez, Elizabeth J. Harker, Mary Allen Staat, Elizabeth P. Schlaudecker, Natasha B. Halasa, Laura S. Stewart, John V. Williams, Marian G. Michaels, Rangaraj Selvarangan, Jennifer E. Schuster, Leila C. Sahni, Julie A. Boom, Geoffrey A. Weinberg, Peter G. Szilagyi, Benjamin R. Clopper, Yingtao Zhou, Meredith L. Mcmorrow, Eileen J. Klein, Heidi L. Moline

Manuscripts, Articles, Book Chapters and Other Papers

SARS-CoV-2 infection in young children is often mild or asymptomatic; however, some children are at risk for severe disease. Data describing the protective effectiveness of COVID-19 mRNA vaccines against COVID-19-associated emergency department (ED) visits and hospitalization in this population are limited. Data from the New Vaccine Surveillance Network, a prospective population-based surveillance system, were used to estimate vaccine effectiveness using a test-negative, case-control design and describe the epidemiology of SARS-CoV-2 in infants and children aged 6 months-4 years during July 1, 2022-September 30, 2023. Among 7,434 children included, 5% received a positive SARS-CoV-2 test result, and 95% received a negative …

Pharmacokinetics And Safety Of A Single Dose Of Telavancin In Pediatric Subjects 2-17 Years Of Age., John S. Bradley, Jennifer Goldman, Laura P. James, Byron Kaelin, Breanne H Y Gibson, Antonio Arrieta

Manuscripts, Articles, Book Chapters and Other Papers

Antimicrobial resistance increases infection morbidity in both adults and children, necessitating the development of new therapeutic options. Telavancin, an antibiotic approved in the United States for certain bacterial infections in adults, has not been examined in pediatric patients. The objectives of this study were to evaluate the short-term safety and pharmacokinetics (PK) of a single intravenous infusion of telavancin in pediatric patients. Single-dose safety and PK of 10 mg/kg telavancin was investigated in pediatric subjects >12 months to ≤17 years of age with known or suspected bacterial infection. Plasma was collected up to 24-h post-infusion and analyzed for concentrations of …

Appropriateness Of Antibiotic Prescribing Varies By Clinical Services At United States Children's Hospitals., Devin T. Diggs, Alison C. Tribble, Rebecca G. Same, Jason G. Newland, Brian R. Lee, Sharing Antimicrobial Reports For Pediatric Stewardship (Sharps) Collaborative

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVE: To describe patterns of inappropriate antibiotic prescribing at US children's hospitals and how these patterns vary by clinical service.

DESIGN: Serial, cross-sectional study using quarterly surveys.

SETTING: Surveys were completed in quarter 1 2019-quarter 3 2020 across 28 children's hospitals in the United States.

PARTICIPANTS: Patients at children's hospitals with ≥1 antibiotic order at 8:00 a.m. on institution-selected quarterly survey days.

METHODS: Antimicrobial stewardship physicians and pharmacists collected data on antibiotic orders and evaluated appropriateness of prescribing. The primary outcome was percentage of inappropriate antibiotics, stratified by clinical service and antibiotic class. Secondary outcomes included reasons for inappropriate use …

Risk Factors For Health Impairments In Children After Hospitalization For Acute Covid-19 Or Mis-C., Aline B. Maddux, Cameron C. Young, Suden Kucukak, Laura D. Zambrano, Margaret M. Newhams, Caitlin K. Rollins, Natasha B. Halasa, Shira J. Gertz, Elizabeth H. Mack, Stephanie Schwartz, Michele Kong, Laura L. Loftis, Katherine Irby, Courtney M. Rowan, Keiko M. Tarquinio, Matt S. Zinter, Hillary Crandall, Natalie Z. Cvijanovich, Jennifer E. Schuster, Julie C. Fitzgerald, Mary A. Staat, Charlotte V. Hobbs, Ryan A. Nofziger, Steven Shein, Heidi Flori, Melissa L. Cullimore, Brandon M. Chatani, Emily R. Levy, Katri V. Typpo, Janet R. Hume, Angela P. Campbell, Adrienne G. Randolph, Overcoming Covid-19 Investigators

Manuscripts, Articles, Book Chapters and Other Papers

OBJECTIVE: To identify risk factors for persistent impairments after pediatric hospitalization for acute coronavirus disease 2019 (COVID-19) or multisystem inflammatory syndrome in children (MIS-C) during the SARS-CoV-2 pandemic.

METHODS: Across 25 U.S. Overcoming COVID-19Network hospitals, we conducted a prospective cohort study of patients

RESULTS: Of 232 children with acute COVID-19, 71 (30.6%) had persistent symptoms and 50 (21.6%) had activity impairments at follow-up; for MIS-C (n = 241), 56 (23.2%) had persistent symptoms and 58 (24.1%) had activity impairments. In adjusted analyses of patients with acute COVID-19, receipt of mechanical ventilation was associated with persistent symptoms [aRR 1.83 …

Updates In Sjs/Ten: Collaboration, Innovation, And Community., Madeline E. Marks, Ramya Krishna Botta, Riichiro Abe, Thomas M. Beachkofsky, Isabelle Boothman, Bruce C. Carleton, Wen-Hung Chung, Ricardo R. Cibotti, Roni P Dodiuk-Gad, Christian Grimstein, Akito Hasegawa, Jay H. Hoofnagle, Shuen-Iu Hung, Benjamin Kaffenberger, Daniela Kroshinsky, Rannakoe J. Lehloenya, Michelle Martin-Pozo, Robert G. Micheletti, Maja Mockenhaupt, Keisuke Nagao, Suman Pakala, Amy Palubinsky, Helena B. Pasieka, Jonathan Peter, Munir Pirmohamed, Melissa Reyes, Hajirah N. Saeed, Jeffery Shupp, Chonlaphat Sukasem, Jhih Yu Syu, Mayumi Ueta, Li Zhou, Wan-Chun Chang, Patrice Becker, Teresa Bellon, Kemberlee Bonnet, Gianpiero Cavalleri, James Chodosh, Anna K. Dewan, Arturo Dominguez, Xinzhong Dong, Elena Ezhkova, Esther Fuchs, Jennifer Goldman, Sonia Himed, Simon Mallal, Alina Markova, Kerry Mccawley, Allison E. Norton, David Ostrov, Michael Phan, Arthur Sanford, David Schlundt, Daniel Schneider, Neil Shear, Kanade Shinkai, Eric Tkaczyk, Jason A. Trubiano, Simona Volpi, Charles S. Bouchard, Sherrie J. Divito, Elizabeth J. Phillips

Manuscripts, Articles, Book Chapters and Other Papers

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) is a predominantly drug-induced disease, with a mortality rate of 15-20%, that engages the expertise of multiple disciplines: dermatology, allergy, immunology, clinical pharmacology, burn surgery, ophthalmology, urogynecology, and psychiatry. SJS/TEN has an incidence of 1-5/million persons per year in the United States, with even higher rates globally. One of the challenges of SJS/TEN has been developing the research infrastructure and coordination to answer questions capable of transforming clinical care and leading to improved patient outcomes. SJS/TEN 2021, the third research meeting of its kind, was held as a virtual meeting on August 28-29, 2021. The …

Relationship Between Epa Level Of Supervision With Their Associated Subcompetency Milestone Levels In Pediatric Fellow Assessment., Richard B. Mink, Carol L. Carraccio, Bruce E. Herman, Pnina Weiss, David A. Turner, Diane E J Stafford, Kathleen A. Mcgann, Jennifer Kesselheim, Deborah C. Hsu, Pamela C. High, Jill J. Fussell, Megan L. Curran, Patricia R. Chess, Cary Sauer, Sarah Pitts, Angela Myers, John D. Mahan, Christiane E L Dammann, Tandy Aye, Alan Schwartz, Subspecialty Pediatrics Investigator Network

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Entrustable Professional Activities (EPA) and competencies represent components of a competency-based education framework. EPAs are assessed based on the level of supervision (LOS) necessary to perform the activity safely and effectively. The broad competencies, broken down into narrower subcompetencies, are assessed using milestones, observable behaviors of one's abilities along a developmental spectrum. Integration of the two methods, accomplished by mapping the most relevant subcompetencies to each EPA, may provide a cross check between the two forms of assessment and uncover those subcompetencies that have the greatest influence on the EPA assessment.

OBJECTIVES: We hypothesized that 1) there would be …

Effectiveness Of Maternal Mrna Covid-19 Vaccination During Pregnancy Against Covid-19-Associated Hospitalizations In Infants Aged <6 Months During Sars-Cov-2 Omicron Predominance - 20 States, March 9, 2022-May 31, 2023., Regina M. Simeone, Laura D. Zambrano, Natasha B. Halasa, Katherine E. Fleming-Dutra, Margaret M. Newhams, Michael J. Wu, Amber O. Orzel-Lockwood, Satoshi Kamidani, Pia S. Pannaraj, Katherine Irby, Aline B. Maddux, Charlotte V. Hobbs, Melissa A. Cameron, Julie A. Boom, Leila C. Sahni, Michele Kong, Ryan A. Nofziger, Jennifer E. Schuster, Hillary Crandall, Janet R. Hume, Mary A. Staat, Elizabeth H. Mack, Tamara T. Bradford, Sabrina M. Heidemann, Emily R. Levy, Shira J. Gertz, Samina S. Bhumbra, Tracie C. Walker, Katherine E. Bline, Kelly N. Michelson, Matt S. Zinter, Heidi R. Flori, Angela P. Campbell, Adrienne G. Randolph, Overcoming Covid-19 Investigators

Manuscripts, Articles, Book Chapters and Other Papers

Infants aged < 6 months are not eligible for COVID-19 vaccination. Vaccination during pregnancy has been associated with protection against infant COVID-19-related hospitalization. The Overcoming COVID-19 Network conducted a case-control study during March 9, 2022-May 31, 2023, to evaluate the effectiveness of maternal receipt of a COVID-19 vaccine dose (vaccine effectiveness [VE]) during pregnancy against COVID-19-related hospitalization in infants aged < 6 months and a subset of infants aged < 3 months. VE was calculated as (1 - adjusted odds ratio) x 100% among all infants aged < 6 months and < 3 months. Case-patients (infants hospitalized for COVID-19 outside of birth hospitalization and who had a positive SARS-CoV-2 test result) and control patients (infants hospitalized for COVID-19-like illness with a negative SARS-CoV-2 test result) were compared. Odds ratios were determined using multivariable logistic regression, comparing the odds of receipt of a maternal COVID-19 vaccine dose (completion of a 2-dose vaccination series or a third or higher dose) during pregnancy with maternal nonvaccination between case- and control patients. VE of maternal vaccination during pregnancy against COVID-19-related hospitalization was 35% (95% CI = 15%-51%) among infants aged < 6 months and 54% (95% CI = 32%-68%) among infants aged < 3 months. Intensive care unit admissions occurred in 23% of all case-patients, and invasive mechanical ventilation was more common among infants of unvaccinated (9%) compared with vaccinated mothers (1%) (p = 0.02). Maternal vaccination during pregnancy provides some protection against COVID-19-related hospitalizations among infants, particularly those aged < 3 months. Expectant mothers should remain current with COVID-19 vaccination to protect themselves and their infants from hospitalization and severe outcomes associated with COVID-19.

Single-Cell Transcriptomics Of Mtb/Hiv Co-Infection, Smita Kulkarni, Janice J. Endsley, Zhao Lai, Todd Bradley, Riti Sharan

Manuscripts, Articles, Book Chapters and Other Papers

Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) co-infection continues to pose a significant healthcare burden. HIV co-infection during TB predisposes the host to the reactivation of latent TB infection (LTBI), worsening disease conditions and mortality. There is a lack of biomarkers of LTBI reactivation and/or immune-related transcriptional signatures to distinguish active TB from LTBI and predict TB reactivation upon HIV co-infection. Characterizing individual cells using next-generation sequencing-based technologies has facilitated novel biological discoveries about infectious diseases, including TB and HIV pathogenesis. Compared to the more conventional sequencing techniques that provide a bulk assessment, single-cell RNA sequencing (scRNA-seq) can reveal complex …

Prospective Assessment Of Inter-Rater Reliability Of A Neonatal Adverse Event Severity Scale., Thomas Salaets, Thierry Lacaze-Masmonteil, Isamu Hokuto, Cheri Gauldin, Amjad Taha, Anne Smits, Liesbeth Thewissen, Ilse Van Horebeek, Armuchou Shoraisham, Khorshid Mohammad, Manami Suzuki, Shiori Komachi, Kurt Michels, Mark A. Turner, Karel Allegaert, Tamorah Lewis

Manuscripts, Articles, Book Chapters and Other Papers

Introduction: To ensure the quality of clinical trial safety data, universal data standards are required. In 2019 the International Neonatal Consortium (INC) published a neonatal adverse event severity scale (NAESS) to standardize the reporting of adverse event (AE) severity. In this study the reliability of AE severity grading with INC NAESS was prospectively assessed in a real-world setting. Methods: Severity of AEs was assessed by two independent observers at each of four centers across the world. In each center two series of 30 neonatal adverse events were assessed by both observers: in a first phase with a generic (Common Terminology …

Kneiffiella Palmae: A Non-Aspergillus Fungal Infection Isolated From A Pulmonary Nodule In A Child With Chronic Granulomatous Disease, Bianca E. Ituarte, Connie Canete-Gibas, Nathan P. Wiederhold, Liset Olarte

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We report the first known human case of Kneiffiella palmae in the medical literature. K. palmae was isolated from a pulmonary nodule in a 7-year-old male with chronic granulomatous disease. The mold was identified as K. palmae at a national reference laboratory, where 17 other human respiratory samples tested positive for K. palmae from 2013 to 2021. Optimal antimicrobial treatment is unknown, but azoles and amphotericin B demonstrated in vitro activity against each tested isolate.

Rapidly Progressing Autoimmune Hemolytic Anemia In A Pediatric Patient With Covid-19., Julia E. Kononowicz, M. Farhan Ali, William Palko, Sean Pyper, Nisha Agasthya

Manuscripts, Articles, Book Chapters and Other Papers

SARS-CoV-2 is a novel virus that is known to have a predilection for complications associated with the respiratory system. Although COVID-19 has a wide spectrum of manifestations, the pathophysiology of severe illness remains poorly understood but is thought to be associated with fulminant cytokine release. While severe complications secondary to COVID-19 in the pediatric population are considered rare, they do happen. Children with and without comorbidities have required intensive care unit admissions for respiratory distress and, more notably, multisystem inflammatory syndrome in children (MIS-C). While MIS-C is associated with hematologic complications, such as thrombocytopenia and coagulopathies, it is not associated …

One Size Does Not Fit All: Advanced Practice Provider Considerations For The Antimicrobial Steward., Kyleen E. Swords, Gina Weddle, Joshua C. Herigon, Paula D. Stering, Matthew S L Lee

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Advanced practice providers are a diverse and established group of antimicrobial prescribers in both ambulatory and inpatient settings. We outline important considerations for antimicrobial stewardship programs and stewards to consider when engaging this important group of providers.

Global Serum Profiling: An Opportunity For Earlier Cancer Detection., Alexandra Sala, James M. Cameron, Paul M. Brennan, Emma J. Crosbie, Tom Curran, Ewan Gray, Pierre Martin-Hirsch, David S. Palmer, Ihtesham U. Rehman, Nicholas J W Rattray, Matthew J. Baker

Manuscripts, Articles, Book Chapters and Other Papers

The advances in cancer research achieved in the last 50 years have been remarkable and have provided a deeper knowledge of this disease in many of its conceptual and biochemical aspects. From viewing a tumor as a 'simple' aggregate of mutant cells and focusing on detecting key cell changes leading to the tumorigenesis, the understanding of cancer has broadened to consider it as a complex organ interacting with its close and far surroundings through tumor and non-tumor cells, metabolic mechanisms, and immune processes. Metabolism and the immune system have been linked to tumorigenesis and malignancy progression along with cancer-specific genetic …

Implementing Text-Messaging To Support And Enhance Delivery Of Health Behavior Change Interventions In Low- To Middle-Income Countries: Case Study Of The Lifestyle Africa Intervention., Frank T. Materia, Joshua M. Smyth, Thandi Puoane, Lungiswa Tsolekile, Kathy Goggin, Stephen R. Kodish, Andrew T. Fox, Ken Resnicow, Scott Werntz, Delwyn Catley

Manuscripts, Articles, Book Chapters and Other Papers

The prevalence of non-communicable diseases, such as diabetes and cardiovascular disease, is rising in low- and middle-income countries (LMICs). Health behavior change (HBC) interventions such as the widely used Diabetes Prevention Program (DPP) are effective at reducing chronic disease risk, but have not been adapted for LMICs. Leveraging mobile health (mHealth) technology such as text messaging (SMS) to enhance reach and participant engagement with these interventions has great promise, yet we lack evidence-informed approaches to guide the integration of SMS specifically to support HBC interventions in LMIC contexts. To address this gap, we integrated guidance from the mHealth literature with …