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Simplified Regimens for Management of Neonates and Young Infants With Severe Infection When Hospital Admission Is Not Possible: Study Protocol for a Randomized, Open-label Equivalence Trial

AFRINEST (AFRIcan NEonatal Sepsis Trial) Group; (2013) Simplified Regimens for Management of Neonates and Young Infants With Severe Infection When Hospital Admission Is Not Possible: Study Protocol for a Randomized, Open-label Equivalence Trial. Pediatric Infectious Disease Journal , 32 S26-S32. 10.1097/inf.0b013e31829ff7d1. Green open access

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Abstract

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 primary outcome is treatment failure in 7 days after enrollment, which includes death or worsening of the clinical condition on any day, or no improvement in the clinical condition by day 4 of treatment. Secondary outcomes include compliance with study therapy, adverse effects due to the study drugs and relapse or death during the week after completion of treatment. / Discussion: The results of this study, along with ongoing studies in Pakistan and Bangladesh, will inform the development of global policy for treatment of severe neonatal infections in resource-limited settings.

Type: Article
Title: Simplified Regimens for Management of Neonates and Young Infants With Severe Infection When Hospital Admission Is Not Possible: Study Protocol for a Randomized, Open-label Equivalence Trial
Open access status: An open access version is available from UCL Discovery
DOI: 10.1097/inf.0b013e31829ff7d1
Publisher version: https://doi.org/10.1097/inf.0b013e31829ff7d1
Language: English
Additional information: Copyright © 2013 by World Health Organization and Bill and Melinda Gates Foundation (WHO and BMGF). This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercialNoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.
Keywords: neonates, young infants, antibiotic treatment, sepsis, severe infection
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
URI: https://discovery.ucl.ac.uk/id/eprint/10121760
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