Efficacy Study for Standard Versus Double Dose of Amoxicillin in WHO Defined Non-severe Pneumonia
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.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Comparison of Standard Versus Double Dose of Amoxicillin in the Treatment of Non-Severe Pneumonia in Children Aged 2-59 Months: A Multi-centre Randomized Double Blind Controlled Trial in Pakistan|
- Number of children with non-severe pneumonia failing treatment with standard and double dose amoxicillin
- To measure the difference in treatment failure rates by day 5 by using the treatment failure definitions by WHO and the modified study definitions.
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||June 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375426
|ARI Research Cell, Children Hospital, Pakistan Institute of Medical Sciences|
|Islamabad, Capital, Pakistan, 44000|
|Principal Investigator:||Tabish Hazir, Fellowship||Children Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan|