Simplified antibiotic regimens for the management of clinically diagnosed severe infections in newborns and young infants in first-level facilities in Karachi, Pakistan: study design for an outpatient randomized controlled equivalence trial.

"This research was funded by the Saving Newborn Lives program of Save the Children Federation, Inc, through a grant from the Bill and Melinda Gates Foundation and the World Health Organization. S.S.T., S.S. and F.J. received training support from the Fogarty International Center, National Institute of Health, grant D43TW007585. A.K.M.Z. designed the study and drafted the manuscript, S.S.T. developed detailed study protocols and manuscript figures, S.S., B.B. and K.K. are study supervisors, M.K. wrote the study site description, H.R. and I.A. wrote the data management description, F.J. assisted with editing and S.C. wrote the analysis plan. The authors have no other funding or conflicts of interest to disclose."

"Several considerations underlie the design of this trial in Karachi and are discussed in detail elsewhere in this supplement. This study was undertaken in primary care clinic settings rather than homes to deliver injectable antibiotic therapy to young infants with PSBI with a view to address ease of potential programmatic uptake in Pakistan. Recently, the Pakistan government has provided funding to revitalize basic health units for curative service delivery and a combination of early identification of sick young infants at home by the government’s lady health workers and referral to the nearest basic health unit for the management of those refusing referral. This should minimize concerns about indiscriminate gentamicin use, injection safety and antimicrobial resistance. This research was funded by the Saving Newborn Lives program of Save the Children Federation, Inc, through a grant from the Bill and Melinda Gates Foundation and the World Health Organization. S.S.T., S.S. and F.J. received training support from the Fogarty International Center, National Institute of Health, grant D43TW007585. A.K.M.Z. designed the study and drafted the manuscript, S.S.T. developed detailed study protocols and manuscript figures, S.S., B.B. and K.K. are study supervisors, M.K. wrote the study site description, H.R. and I.A. wrote the data management description, F.J. assisted with editing and S.C. wrote the analysis plan. The authors have no other funding or conflicts of interest to disclose."

"This study was reviewed and approved by the Research Ethics Review Committees of Aga Khan University, London School of Hygiene and Tropical Medicine, and the WHO. The trial has been registered at Clinicaltrials.gov before enrolment was initiated (NCT01027429)."