Efficacy of Single Versus Double Dose of Oral Amoxicillin for Non-Severe Pneumonia in Children
Status:
Completed
Trial end date:
2004-06-01
Target enrollment:
Participant gender:
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.