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Efficacy Study for Standard Versus Double Dose of Amoxicillin in WHO Defined Non-severe Pneumonia

NCT01375426 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2011-06-17

No results posted yet for this study

Summary

Over a period of years there have been numerous reports from many developing countries including Pakistan showing a rising treatment failure rate with first line drugs (amoxicillin and cotrimoxazole) in non-severe pneumonia in children. The reasons for this rise in treatment failure rates are not entirely clear but one of the reasons is thought to be increasing antimicrobial resistance of H. influenzae and Strep. pneumoniae to first line drugs. There is microbiological data which suggests that this resistance can be overcome by increasing the dose of amoxicillin. The investigators propose to treat non-severe pneumonia with double dose amoxicillin in an attempt to demonstrate a decrease in treatment failure rates. This will be a multicentre, double blind randomized controlled trial in children 2-59 months of age with non-severe pneumonia comparing the clinical outcome between the standard and double dose groups.

It has been felt that the WHO criteria for treatment failure in children with pneumonia are too stringent and have never been systematically evaluated in the community. The investigators also propose to modify WHO criteria and field test them in this trial in an attempt to demonstrate that less stringent treatment failure criteria would have an impact on the overall treatment failure rates in pneumonia.

Hypothesis:

Therapy outcome with double dose of oral amoxicillin is not different than the standard dose of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2-59 months old children.

Conditions

Interventions

DRUG

Oral amoxicillin

Sponsors & Collaborators

Principal Investigators

  • Tabish Hazir, Fellowship · Children Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-09-30
Completion
2004-06-30

Countries

  • Pakistan

Study Locations

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Entities

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 NCT01375426 on ClinicalTrials.gov