Efficacy Study for Standard Versus Double Dose of Amoxicillin in WHO Defined Non-severe Pneumonia
Status:
Completed
Trial end date:
2004-06-01
Target enrollment:
Participant gender:
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.