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

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 unn...

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Bibliographic Details
Published in:	Clinical infectious diseases Vol. 52; no. 3; pp. 293 - 300
Main Authors:	Hazir, Tabish, Nisar, Yasir Bin, Abbasi, Saleem, Ashraf, Yusra Pervaiz, Khurshid, Joza, Tariq, Perveen, Asghar, Rai, Murtaza, Asifa, Masood, Tahir, Maqbool, Sajid
Format:	Journal Article
Language:	English
Published:	Oxford Oxford University Press 01-02-2011
Subjects:	Amoxicillin - administration & dosage Anti-Bacterial Agents - administration & dosage Antibacterial agents Antibiotics Antibiotics. Antiinfectious agents. Antiparasitic agents ARTICLES AND COMMENTARIES Biological and medical sciences Breathing Child health services Child, Preschool Children Children & youth Clinical trials Comparative analysis Developing countries Diseases Double-Blind Method Female Health outcomes Humans Infant Infectious diseases Male Medical sciences Medical treatment Medical treatment failures Pakistan Pharmacology. Drug treatments Placebos Placebos - administration & dosage Pneumology Pneumonia Pneumonia - drug therapy Pneumonia - pathology Respiratory diseases Respiratory system : syndromes and miscellaneous diseases Severity of Illness Index Treatment Failure Treatment Outcome World Asia Pakistan Human Lung disease Pneumonia Respiratory disease β-Lactams Oral administration Penicillin derivatives Infection Antibiotic Treatment Public health organization Amoxicillin Double blind study Antibacterial agent Child Comparative study
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Summary:	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.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23
ISSN:	1058-4838 1537-6591
DOI:	10.1093/cid/ciq142