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Scientific Rationale for Study Design of Community-Based Simplified Antibiotic Therapy Trials in Newborns and Young Infants With

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Scientific Rationale for Study Design of Community-Based Simplified Antibiotic Therapy Trials in Newborns and Young Infants With eCommons@AKU Paediatrics and Child Health, East Africa Medical College, East Africa 2013 Scientific ationaler 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 Aga Khan University Abdullah H. Baqui Johns Hopkins Bloomberg School of Public Health Shamim Ahmad Qazi World Health Organization Rajiv Bahl World Health Organization Samir Saha Kinshasa School of Public Health Follow this and additional works at: https://ecommons.aku.edu/eastafrica_fhs_mc_paediatr_child_health See next page for additional authors Part of the Pediatrics Commons Recommended Citation Zaidi, A. K., Baqui, A. H., Qazi, S. A., Bahl, R., Saha, S., Ayede, A. I., Adejuyigbe, E. A., Engmann, C., Esamai, F., Tshefu, A. K., Wammanda, R. D., Falade, A. G., Odebiyi, A., Gisore, P., Longombe, A. L., Ogala, W. N., Tikmani, S. S., Uddin Ahmed, A. N., Wall, S., Brandes, N., Roth, D. E., Darmstadt, G. L. (2013). 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.. The Pediatric Infectious Disease Journal, 32(9), s7-s11. Available at: https://ecommons.aku.edu/eastafrica_fhs_mc_paediatr_child_health/93 Authors 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 This article is available at eCommons@AKU: https://ecommons.aku.edu/eastafrica_fhs_mc_paediatr_child_health/93 SUPPLEMENT 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, MB BS, SM,* Abdullah H. Baqui, MB BS, DrPH,† Shamim Ahmad Qazi, MB BS, DCH, MSc, MD,‡ Rajiv Bahl, MB BS, MD, PhD,‡ Samir Saha, PhD,§ Adejumoke I. Ayede, MB BS, MSc, FMCPaed,¶ Ebunoluwa A. Adejuyigbe, MB ChB, FMCPaed,|| Cyril Engmann, MD, FAAP,**†† Fabian Esamai, MB ChB, MMed, MPH, PhD,‡‡ Antoinette Kitoto Tshefu, MD, PhD, MPH,§§ Robinson D. Wammanda, MB BS, FWACP Paed,¶¶ Adegoke G. Falade, MB BS, FMCPaed, MD, FRCP,§ Adetanwa Odebiyi, MSc,|||| Peter Gisore, MB ChB,†† Adrien Lokangaka Longombe, MD,§§ William N. Ogala, MB BS, FMCPaed, FWACP Paed,¶¶ Shiyam Sundar Tikmani, MB BS,* A. S. M. Nawshad Uddin Ahmed, FCPS,§ Steve Wall, MD,*** Neal Brandes, MHS,††† Daniel E. Roth, PhD,‡‡‡ and Gary L. Darmstadt, MD, MS†† Accepted for publication June 5, 2013. Background: Newborns and young infants suffer high rates of infections From the *Aga Khan University, Karachi, Pakistan; †Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; ‡Department of Maternal, New- in South Asia and sub-Saharan Africa. Timely access to appropriate anti- born, Child and Adolescent Health, World Health Organization, Geneva, biotic therapy is essential for reducing mortality. In an effort to develop Switzerland; ¶Department of Pediatrics, College of Medicine, University of community case management guidelines for young infants, 0–59 days old, Ibadan, Ibadan, Nigeria; ||Department of Paediatrics and Child Health, Oba- with clinically diagnosed severe infections, or with fast breathing, 4 trials femi Awolowo University, Ile-Ife, Nigeria; **Departments of Pediatrics and Maternal Child Health, Schools of Medicine and Public Health, University of simplified antibiotic therapy delivered in primary care clinics (Pakistan, of North Carolina, Chapel Hill, North Carolina; ††Bill and Melinda Gates Democratic Republic of Congo, Kenya and Nigeria) or at home (Bangla- Foundation, Seattle, Washington; ‡‡Department of Child Health and Paedi- desh and Nigeria) are being conducted. atrics, School of Medicine, Moi University, Eldoret, Kenya; §§Department Methods: This article describes the scientific rationale for these trials, of Community Health, Kinshasa School of Public Health, Kinshasa, Demo- graphic Republic of Congo; ¶¶Department of Paediatrics, Ahmadu Bello which share major elements of trial design. All the trials are in settings of University Teaching Hospital, Ahmadu Bello University, Zaria, Nigeria; and high neonatal mortality, where hospitalization is not feasible or frequently ||||Department of Sociology, Obafemi Awolowo University, Ile-Ife, Nigeria; refused. All use procaine penicillin and gentamicin intramuscular injections ***Save the Children/Saving Newborn Lives; †††United States Agency for for 7 days as reference therapy and compare this to various experimental International Development, Washington DC; and ‡‡‡Hospital for SickKids, Toronto, Canada. arms utilizing comparatively simpler combination regimens with fewer The views and opinions expressed in this article are those of the author(s) and not injections and oral amoxicillin. necessarily the views and opinions of the United States Agency for Interna- Conclusion: The results of these trials will inform World Health Organiza- tional Development or World Health Organization. tion policy regarding community case management of young infants with This journal article was supported with funds provided by Save the Children’s Saving Newborn Lives Program through a grant from the Bill and Melinda clinical severe infections or with fast breathing. Gates Foundation. Its contents are solely the responsibility of the authors and do not necessarily reflect the views of Save the Children or the Bill and Key Words: newborn, young infant, sepsis, pneumonia, meningitis, clini- Melinda Gates Foundation. cally severe infections, fast breathing, community management, community The Pakistan study was funded by the Saving Newborn Lives program of Save case management, antibiotic, gentamicin, amoxicillin, procaine penicillin, the Children Federation, Inc, through a grant from the Bill and Melinda South Asia, sub-Saharan Africa Gates Foundation and the World Health Organization. S.S.T. received train- ing support from the Fogarty International Center, National Institute of (Pediatr Infect Dis J 2013;32:S7–S11) Health, grant D43TW007585. The Bangladesh study was funded by the United States Agency for Interna- tional Development, through a cooperative agreement (GHS-A-00-09- 00004-00) with the Johns Hopkins Bloomberg School of Public Health, World Health Organization and by the Saving Newborn Lives program nfections in the neonatal period are responsible for an estimated of Save the Children Federation, Inc, through a grant from the Bill and I12% of under-5 child mortality.1 Most newborns with severe infec- Melinda Gates Foundation. The authors have no other funding or conflicts tions (sepsis, pneumonia, meningitis) in South Asia and sub-Saharan of interest to disclose. 2–6 The African study was funded by the World Health Organization through a grant Africa die without access to hospitalization and appropriate therapy, from the Bill and Melinda Gates Foundation. prompting the need for alternative strategies for home or first-level Address for correspondence: Anita K. M. Zaidi, MB BS, SM, Professor and facility-based management in countries with a high burden of neo- Chair, Department of Paediatrics and Child Health, Aga Khan University, Sta- natal deaths.3–5,7 This article describes the scientific rationale for the dium Road, PO Box 3500, Karachi, Pakistan. E-mail: [email protected]. study design of 3 randomized controlled equivalence trials evaluating Copyright © 2013 by World Health Organization, United States Agency for Inter- national Development and Bill and Melinda Gates Foundation (WHO, USAID, simplified antibiotic regimens for management of clinically diagnosed and BMGF). This is an open-access article distributed under the terms of the severe infections in newborns and young infants in community settings Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, in Bangladesh, Pakistan and a multicountry study in Africa (Demo- where it is permissible to download and share the work provided it is properly cratic Republic of Congo, Kenya and Nigeria). Additionally, the sci- cited. The work cannot be changed in any way or used commercially. ISSN: 0891-3668/13/3209-00S7 entific reasoning underlying a trial of simplified antibiotic therapy for DOI: 10.1097/INF.0b013e31829ff5fc management of young infants who present with fast breathing alone The Pediatric Infectious Disease Journal • Volume 32, Number 9, Supplement, September 2013 www.pidj.com | S7 Zaidi et al The Pediatric Infectious Disease Journal • Volume 32, Number 9, Supplement, September 2013 is also described. Although the individual study designs are adapted this algorithm influence specificity for the diagnosis of infection, to site and country needs and are detailed in the site-specific meth- considerations that are important in equivalence trial settings where ods articles,8–11 here we focus on the overarching scientific approach to a nonspecific definition of infection could dilute out important dif- case definitions, selection of trial sites, participant inclusion/exclusion ferences in therapeutic options among a smaller group of infants criteria, choice of antibiotics and
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