AFRINEST (AFRIcan NEonatal Sepsis Trial) Group;
(2013)
Treatment of Fast Breathing in Neonates and Young Infants With Oral Amoxicillin Compared With Penicillin–Gentamicin Combination: Study Protocol for a Randomized, Open-label Equivalence Trial.
The Pediatric Infectious Disease Journal
, 32
S33-S38.
10.1097/inf.0b013e31829ff7eb.
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Abstract
Background: The World Health Organization recommends hospitalization and injectable antibiotic treatment for young infants (0–59 days old), who present with signs of possible serious bacterial infection. Fast breathing alone is not associated with a high mortality risk for young infants and has been treated with oral antibiotics in some settings. This trial was designed to examine the safety and efficacy of oral amoxicillin for young infants with fast breathing compared with that of an injectable penicillin–gentamicin combination. The study is currently being conducted in the Democratic Republic of Congo, Kenya and Nigeria. / Methods/Design: This is a randomized, open-label equivalence trial. All births in the community are visited at home by trained community health workers to identify sick infants who are then referred to a trial study nurse for assessment. The primary outcome is treatment failure by day 8 after enrollment, defined as clinical deterioration, development of a serious adverse event including death, persistence of fast breathing by day 4 or recurrence up to day 8. Secondary outcomes include adherence to study therapy, relapse, death between days 9 and 15 and adverse effects associated with the study drugs. Study outcomes are assessed on days 4, 8, 11 and 15 after randomization by an independent outcome assessor who is blinded to the treatment being given. / Discussion: The results of this study will help inform the development of policies for the treatment of fast breathing among neonates and young infants in resource-limited settings.
| Type: | Article |
|---|---|
| Title: | Treatment of Fast Breathing in Neonates and Young Infants With Oral Amoxicillin Compared With Penicillin–Gentamicin Combination: 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.0b013e31829ff7eb |
| Publisher version: | https://doi.org/10.1097/inf.0b013e31829ff7eb |
| 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, fast breathing, 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/10121759 |
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