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.


AFRIcan NEonatal Sepsis Trial Group, . (incd. Cousens, S; ); (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 Suppl 1. S33-8. ISSN 0891-3668 DOI: 10.1097/INF.0b013e31829ff7eb

[img]
Preview
Text - Published Version
License:

Download (358Kb) | Preview

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.

Item Type: Article
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Research Centre: Centre for Maternal, Reproductive and Child Health (MARCH)
Tropical Epidemiology Group
PubMed ID: 23945574
URI: http://researchonline.lshtm.ac.uk/id/eprint/1878062

Statistics


Download activity - last 12 months
Downloads since deposit
501Downloads
283Hits
Accesses by country - last 12 months
Accesses by referrer - last 12 months
Impact and interest
Additional statistics for this record are available via IRStats2

Actions (login required)

Edit Item Edit Item