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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Ambulatory short-course high-dose oral amoxicillin for treatment of severe pneumonia in children: a randomised equivalency trial
The Lancet, Volume 371, No. 9606, Year 2008
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Description
Background: WHO case management guidelines for severe pneumonia involve referral to hospital for treatment with parenteral antibiotics. If equally as effective as parenteral treatment, home-based oral antibiotic treatment could reduce referral, admission, and treatment costs. Our aim was to determine whether home treatment with high-dose oral amoxicillin and inpatient treatment with parenteral ampicillin were equivalent for the treatment of severe pneumonia in children. Methods: This randomised, open-label equivalency trial was done at seven study sites in Pakistan. 2037 children aged 3-59 months with severe pneumonia were randomly allocated to either initial hospitalisation and parenteral ampicillin (100 mg/kg per day in four doses) for 48 h, followed by 3 days of oral amoxicillin (80-90 mg/kg per day; n=1012) or to home-based treatment for 5 days with oral amoxicillin (80-90 mg/kg per day in two doses; n=1025). Follow-up assessments were done at 1, 3, 6, and 14 days after enrolment. The primary outcome was treatment failure (clinical deterioration) by day 6. Analyses were done per protocol and by intention to treat. This trial is registered, ISRCTN95821329. Findings: In the per-protocol population, 36 individuals were excluded from the hospitalised group and 37 from the ambulatory group, mainly because of protocol violations or loss to follow-up. There were 87 (8·6%) treatment failures in the hospitalised group and 77 (7·5%) in the ambulatory group (risk difference 1·1%; 95% CI -1·3 to 3·5) by day 6. Five (0·2%) children died within 14 days of enrolment, one in the ambulatory group and four in the hospitalised group. In each case, treatment failure was declared before death and the antibiotic had been changed. None of the deaths were considered to be associated with treatment allocation; there were no serious adverse events reported in the trial. Interpretation: Home treatment with high-dose oral amoxicillin is equivalent to currently recommended hospitalisation and parenteral ampicillin for treatment of severe pneumonia without underlying complications, suggesting that WHO recommendations for treatment of severe pneumonia need to be revised. © 2008 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Hazir, Tabish
Pakistan, Islamabad
Pakistan Institute of Medical Sciences
Fox, Leanne Anne M.
United States, Boston
School of Public Health
Nisar, Yasir Bin
Pakistan, Islamabad
Pakistan Institute of Medical Sciences
Fox, Matthew P.
United States, Boston
School of Public Health
MacLeod, William Bruce
United States, Boston
School of Public Health
Asghar, Rai Muhammad
Pakistan, Rawalpindi
Rawalpindi General Hospital
Simon, Jonathon L.
United States, Boston
School of Public Health
Thea, Donald M.
United States, Boston
School of Public Health
Qazi, Shamim Ahmad
Switzerland, Geneva
Organisation Mondiale de la Santé
Statistics
Citations: 146
Authors: 9
Affiliations: 8
Identifiers
Doi:
10.1016/S0140-6736(08)60071-9
ISSN:
01406736
Research Areas
Health System And Policy
Maternal And Child Health
Study Design
Cross Sectional Study
Cohort Study