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Efficacy of Single Versus Double Dose of Oral Amoxicillin for Non-Severe Pneumonia in Children

NCT00130013 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2005-09-23

No results posted yet for this study

Summary

The World Health Organization's (WHO) standard case management strategy for reducing acute respiratory infection (ARI) related mortality recommends oral cotrimoxazole and oral amoxicillin as first line drugs for the treatment of pneumonia. In 1989, the Pakistan Ministry of Health (MOH) adopted this strategy to control ARI mortality and recommended cotrimoxazole for treatment of outpatients pneumonia due to lower costs. A number of studies subsequently performed have shown significant in vivo and in vitro resistance of H. influenzae and S. pneumoniae, the commonest bacteria causing childhood pneumonia, to cotrimoxazole.

Although on a case by case basis for pneumonia, in vitro resistance does not correlate very well with in vivo failures, nevertheless, clinical failure rate for pneumonia therapy has increased in Pakistan over the years. One can hypothesize that if bacterial pneumonia is a certain proportion of all pneumonia cases, the rise in clinical failures may be related to increasing antimicrobial resistance. Therefore, it is probable that this rising clinical failure rate could be a reflection of increasing resistance. There may be an increase in antimicrobial resistance of S. pneumoniae and H. influenzae to amoxicillin over the period of years and the rising treatment failure could be a reflection of the rising minimum inhibitory concentrations (MIC's) (\> 2 mcg/ml for H. influenzae, 1993-94), thereby, resulting in this increasing failure rate.

For the current study the researchers propose a multicentre, randomized, controlled double blind trial in which standard versus double dose oral amoxicillin for three days for the treatment of non-severe pneumonia in children less than five years of age will be compared.

Primary Objective:

To compare the proportion of children 2 - 59 months of age presenting with non-severe pneumonia, who achieve clinical resolution on day 5 with standard (15 mg/kg/8hrly) versus double dose (30 mg/kg/8hrly) of oral amoxicillin therapy given for 3 days.

Secondary Objective:

To follow the clinical course of non-severe pneumonia with the alternative criteria of treatment failure (signs of deterioration i.e. lower chest indrawing and appearance of danger signs) on or before day 3 and compare them with other children who have persistent fast breathing (respiratory rate above the cut off for age) on day 3.

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 · ARI Research Cell, 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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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 NCT00130013 on ClinicalTrials.gov