Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi

Phase 4 Terminated 963 enrolled Aga Khan University

RandomizedSingle-groupQuadruple-blindTreatment

Summary

The aim of the study is to determine optimal management of isolated fast breathing in young infants in a trial design conducted in primary care settings. The investigators hypothesized that proportion of infants who fail therapy will be 4% in each group. A 6% or less difference in failure rate will be considered equivalent.

Timeline

Start: 2012-05
Primary completion: 2014-05
Completion: 2014-05

Outcome

Outcome not reported

Stopped: “The study was stopped by DSMB based on high treatment failure rate in placebo compared to active drug.”

Publications

Tikmani SS, Muhammad AA, Shafiq Y, Shah S, Kumar N, Ahmed I, Azam I, Pasha O, Zaidi AK. Ambulatory Treatment of Fast Breathing in Young Infants Aged <60 Days: A Double-Blind, Randomized, Placebo-Controlled Equivalence Trial in Low-Income Settlements of Karachi. Clin Infect Dis. 2017 Jan 15;64(2):184-189. doi: 10.1093/cid/ciw690. Epub 2016 Oct 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amoxicillin	Other / unclassified	80 mg/kg	Oral
Comparator	Amoxicillin	Other / unclassified	100 mg/kg	Oral