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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

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 …