Journal Article

Comparison of Oral Amoxicillin with Placebo for the Treatment of World Health Organization–Defined Nonsevere Pneumonia in Children Aged 2–59 Months: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial in Pakistan

Tabish Hazir, Yasir Bin Nisar, Saleem Abbasi, Yusra Pervaiz Ashraf, Joza Khurshid, Perveen Tariq, Rai Asghar, Asifa Murtaza, Tahir Masood and Sajid Maqbool

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 52, issue 3, pages 293-300
Published in print February 2011 | ISSN: 1058-4838
Published online February 2011 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1093/cid/ciq142
Comparison of Oral Amoxicillin with Placebo for the Treatment of World Health Organization–Defined Nonsevere Pneumonia in Children Aged 2–59 Months: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial in Pakistan

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Background. World Health Organization (WHO) acute respiratory illness case management guidelines classify children with fast breathing as having pneumonia and recommend treatment with an antibiotic. There is concern that many of these children may not have pneumonia and are receiving antibiotics unnecessarily. This could increase antibiotic resistance in the community. The aim was to compare the clinical outcome at 72 h in children with WHO-defined nonsevere pneumonia when treated with amoxicillin, compared with placebo.

Methods. We performed a double-blind, randomized, equivalence trial in 4 tertiary hospitals in Pakistan. Nine hundred children aged 2–59 months with WHO defined nonsevere pneumonia were randomized to receive either 3 days of oral amoxicillin (45mg/kg/day) or placebo; 873 children completed the study. All children were followed up on days 3, 5, and 14. The primary outcome was therapy failure defined a priori at 72 h.

Results. In per-protocol analysis at day 3, 31 (7.2%) of the 431 children in the amoxicillin arm and 37 (8.3%) of the 442 in placebo group had therapy failure. This difference was not statistically significant (odds ratio [OR], .85; 95%CI, .50–1.43; P = .60). The multivariate analysis identified history of difficult breathing (OR, 2.86; 95% CI, 1.29–7.23; P = .027) and temperature >37.5°C 100°F at presentation (OR, 1.99; 95% CI, 1.37–2.90; P = .0001) as risk factors for treatment failure by day 5.

Conclusion. Clinical outcome in children aged 2–59 months with WHO-defined nonsevere pneumonia is not different when treated with an antibiotic or placebo. Similar trials are needed in countries with a high burden of pneumonia to rationalize the use of antibiotics in these communities.

Clinical Trials. NCT00851487.

Journal Article.  4035 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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