• 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, and Gary L Darmstadt.
• Aga Khan University, Karachi, Pakistan.
• Pediatr. Infect. Dis. J. 2013 Sep 1;32 Suppl 1:S7-11.

BackgroundNewborns 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.MethodsThis article describes the scientific rationale for these trials, which share major elements of trial design. All the trials are in settings of high neonatal mortality, where hospitalization is not feasible or frequently refused. All use procaine penicillin and gentamicin intramuscular injections for 7 days as reference therapy and compare this to various experimental arms utilizing comparatively simpler combination regimens with fewer injections and oral amoxicillin.ConclusionThe results of these trials will inform World Health Organization policy regarding community case management of young infants with clinical severe infections or with fast breathing.

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