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Scientific Rationale For Study Design Of Community-Based Simplified Antibiotic Therapy Trials In Newborns And Young Infants With Clinically Diagnosed Severe Infections Or Fast Breathing In South Asia And Sub-Saharan Africa., Anita K. M. Zaidi, Abdullah H. Baqui, Shamim Ahmad Qazi, Rajiv Bahl, Samir Saha, Adejumoke I. Ayede, Ebunoluwa A. Adejuyigbe, Cyril Engmann, Fabian Esamai, Antoinette Kitoto Tshefu, Robinson D. Wammanda, Adegoke G. Falade, Adetanwa Odebiyi, Peter Gisore, Adrien Lokangaka Longombe, William N. Ogala, Shiyam Sundar Tikmani, A. S. M. Nawshad Uddin Ahmed, Steve Wall, Neal Brandes, Daniel E. Roth, Gary L. Darmstadt
Scientific Rationale For Study Design Of Community-Based Simplified Antibiotic Therapy Trials In Newborns And Young Infants With Clinically Diagnosed Severe Infections Or Fast Breathing In South Asia And Sub-Saharan Africa., Anita K. M. Zaidi, Abdullah H. Baqui, Shamim Ahmad Qazi, Rajiv Bahl, Samir Saha, Adejumoke I. Ayede, Ebunoluwa A. Adejuyigbe, Cyril Engmann, Fabian Esamai, Antoinette Kitoto Tshefu, Robinson D. Wammanda, Adegoke G. Falade, Adetanwa Odebiyi, Peter Gisore, Adrien Lokangaka Longombe, William N. Ogala, Shiyam Sundar Tikmani, A. S. M. Nawshad Uddin Ahmed, Steve Wall, Neal Brandes, Daniel E. Roth, Gary L. Darmstadt
Paediatrics and Child Health, East Africa
Background: Newborns and young infants suffer high rates of infections in South Asia and sub-Saharan Africa. Timely access to appropriate antibiotic therapy is essential for reducing mortality. In an effort to develop community case management guidelines for young infants, 0–59 days old, with clinically diagnosed severe infections, or with fast breathing, 4 trials of simplified antibiotic therapy delivered in primary care clinics (Pakistan, Democratic Republic of Congo, Kenya and Nigeria) or at home (Bangladesh and Nigeria) are being conducted.
Methods: This article describes the scientific rationale for these trials, which share major elements of trial design. All the trials are …
Simplified Regimens For Management Of Neonates And Young Infants With Severe Infection When Hospital Admission Is Not Possible, Antoinette Tshef, Adrien Lokangaka, Cyril Engmann, Fabian Esamai, Peter Gisore, Adejumoke Idowu Ayede, Adegoke Gbadegesin Falade, Ebunoluwa A. Adejuyigbe, Chineme Henry Anyabolu, Robinson D. Wammanda, William N. Ogala, Lu Gram, Simon Cousens, Rajiv Bahl, Nigel Rollins, Sachiyo Yoshida, Shamim Ahmad Qazi
Simplified Regimens For Management Of Neonates And Young Infants With Severe Infection When Hospital Admission Is Not Possible, Antoinette Tshef, Adrien Lokangaka, Cyril Engmann, Fabian Esamai, Peter Gisore, Adejumoke Idowu Ayede, Adegoke Gbadegesin Falade, Ebunoluwa A. Adejuyigbe, Chineme Henry Anyabolu, Robinson D. Wammanda, William N. Ogala, Lu Gram, Simon Cousens, Rajiv Bahl, Nigel Rollins, Sachiyo Yoshida, Shamim Ahmad Qazi
Paediatrics and Child Health, East Africa
Background: In resource-limited settings, most young infants with signs of severe infection do not receive the recommended inpatient treatment with intravenous broad spectrum antibiotics for 10 days or more because such treatment is not accessible, acceptable or affordable to families. This trial was initiated in the Democratic Republic of Congo, Kenya and Nigeria to assess the safety and efficacy of simplified treatment regimens for the young infants with signs of severe infection who cannot receive hospital care.
Methods: This is a randomized, open-label equivalence trial in which 3600 young infants with signs of clinical severe infection will be enrolled. The …