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Randomized Trial of Amoxicillin Versus Placebo for (Fast Breathing) Pneumonia

NCT02372461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2019-09-16

No results posted yet for this study

Summary

The relative benefits and risks of antibiotic therapy in WHO defined fast breathing pneumonia in pre-school children in resource limited settings are controversial both at an individual and public health level. Most infections are viral or self-limiting and non-selective drug treatment has contributed to the global epidemic of antibiotic resistance. There is no high quality trial evidence in managing children with fast breathing in community settings and the WHO itself has called for evidence on which to update guidance. The investigators proposed non inferiority trial comparing standard antibiotic treatment with placebo in poor urban slum settings in South Asia to address this deficit.

Conditions

Interventions

DRUG

Placebo

This is an non inferiority trial, the intervention is a placebo

DRUG

Amoxicillin

Amoxicillin Liquid

Sponsors & Collaborators

  • Aga Khan University

    lead OTHER

Principal Investigators

  • Fyezah Jehan, Msc · Aga Khan Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-09
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02372461 on ClinicalTrials.gov