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Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59 Months

NCT00851487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2009-02-26

No results posted yet for this study

Summary

Many children with "non-severe pneumonia" (cough and fast breathing) have neither clinical pneumonia as assessed by physicians nor pneumonia on chest radiographs. Inappropriate use of antibiotics for these cases is leading to resistant strains of bacteria in the community. Evidence shows that almost 50% of antibiotic prescription is unnecessary.As over half of antibiotic prescription for ARI are not necessary since most of these infections are viral and do not respond to antibiotic therapy which will be source of resistance in the community.

To address this issue the investigators conducted this randomized, double blind placebo controlled clinical trial of oral Amoxicillin versus placebo in children with non-severe pneumonia taking into account all the necessary safety precautions for their well being.

The study hypothesis was that the clinical outcome of children 2 to 59 months of age with cough and fast breathing (WHO defined non-severe pneumonia) with or without wheezing is equivalent, whether they are treated with amoxicillin or placebo.

Conditions

Interventions

DRUG

Amoxicillin

Oral Amoxicillin 15 mg/kg/dose 8 hourly

DRUG

Placebo

The placebo was similar in colour, consistency and volume as oral amoxicillin

Sponsors & Collaborators

Principal Investigators

  • Dr. Tabish Hazir, FCPS-Peds · Overall Head of Research Cell

  • Dr. Yusra Ashraf, MBBS · Research Administrator to ARI Research Cell

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00851487 on ClinicalTrials.gov