NCT01533818
Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi
The trial's own stop reason says it succeeded, but ClinicalTrials.gov shows no posted results — flagged as a possible orphaned finding.
- Phase
- PHASE4
- Enrollment
- 963
- Sponsor class
- OTHER
- Taxonomy code
- goal_met
What the registry says
“The study was stopped by DSMB based on high treatment failure rate in placebo compared to active drug.”
What real verification found
This trial's positive result WAS published — it is not an unused result sitting unpublished. Citation: Tikmani SS, Sadiq K, Ali SA, et al. "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." Clinical Infectious Diseases. 2017;64(2):184-189. PMID: 27941119. Published online 19 Oct 2016 (https://academic.oup.com/cid/article/64/2/184/2660324, https://pubmed.ncbi.nlm.nih.gov/27941119/). The abstract explicitly cites NCT01533818 as the trial registration. Reported outcome matches the CT.gov why_stopped text almost verbatim: 12/423 (2.8%) treatment failures in the amoxicillin arm vs 25/426 (5.9%) in the placebo arm, plus 2 deaths in the placebo arm and none in the amoxicillin arm — the trial was halted at interim analysis by the DSMB because it "failed to show equivalence of placebo to amoxicillin" (i.e., placebo was doing worse, so amoxicillin's benefit was too clear/important to let placebo arm continue). Screening/enrollment window (4 June 2012 - 29 May 2014) matches the record's 2014-05 completion date. There is also a companion invited editorial in the same CID issue discussing this exact trial's implications for WHO pneumonia management guidelines: "Treating Sick Young Infants With Only Fast Breathing With Oral Amoxicillin in Resource-Limited Settings: Taking the High Road?" (https://academic.oup.com/cid/article/64/2/190/2660325, PMC5215216) — showing the result was not just published but engaged with by the field. The CT.gov has_results=false flag is a registry-reporting gap (results were never formally entered into the CT.gov structured results database), not evidence the science went unused — it was published in a peer-reviewed journal and cited/discussed.
Full search & fetch trail
WebSearch: "NCT01533818 fast breathing infants Karachi"; WebSearch: "Community based management fast breathing young infants Karachi Aga Khan University amoxicillin DSMB"; WebFetch on pubmed.ncbi.nlm.nih.gov/27941119/ (confirmed NCT01533818 registration number in abstract, DSMB stopping reason, and enrollment/outcome numbers matching the CT.gov record); WebFetch attempt on clinicaltrials.gov/study/NCT01533818 (returned only nav/header, no substantive extra info, not needed given PubMed confirmation).