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To determine whether two cheap antifolates (chlorproguanil-dapsone and sulfadoxine-pyrimethamine) which work against falciparum malaria in this region are sufficiently effective against vivax malaria to be deployed in areas where diagnosis is poor and the burden of malaria is high, a randomised controlled trial of the three drugs is being undertaken comparing their efficacy in treating malaria.
Full description
Objectives:
Primary:
To evaluate the comparative efficacy of chlorproguanil / dapsone with sulfadoxine-pyrimethamine for the treatment of vivax malaria in Pakistan and eastern Afghanistan.
Secondary:
Study Population:
750 P.vivax positive individuals recruited from the Malaria Reference Centre in Jalalabad, Afghanistan and at health facilities in Afghan refugee camps in North West Frontier Province (NWFP), Pakistan supervised by HealthNet International
Efficacy Parameters :
Primary Efficacy Variable:
• Day 14 slide clearance rate (complete clearance of parasites), assessed by microscopists who are blind to treatment allocation. Slides will be double read.
Secondary Efficacy Variables
Safety Parameters:
Adverse events and laboratory findings will be monitored in all patients. Regular haemoglobin to identify haemolysis.
Study design:
Recruitment and administration:
Recruitment and administration of all treatments will be directly observed by the trial coordinator and trial pharmacist, and/or health unit clinician.
Dosing Schedules:
Chlorproguanil-dapsone (Lapdap): (target doses 2.0 and 2.5 mg/kg respectively) daily for 3 days .
Sulfadoxine - pyrimethamine (SP): (target doses 1.25 and 25.0 mg/kg respectively) once only.
Chloroquine (CQ): (target dose 25mg/kg ) daily for 3 days.
Follow up:
Patients will return to the clinic on days 0, 1, 2, 3, 7, 14, 21 and 28 for supervised dosing, thick and thin smears, blood spot filter papers, update of clinical record forms, determination of haemoglobin, full blood cell counts, liver function tests, determination of adverse events and concomitant medication details, as appropriate.
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Data sourced from clinicaltrials.gov
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