A Phase 2 interventional study of Cotrifazid vs mefloquine or quinine+SP in Clinical Malaria, sponsored by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland. Terminated at 1 site in Papua New Guinea. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2006-05-08.
Sponsored by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland · Phase 2, Interventional, and Treatment
The purpose of this study was to assess the safety and efficacy of Cotrifazid to treat uncomplicated resistant malaria and to compare the outcome with mefloquine or quinine+sulfadoxine/pyrimethamine (SP)
Design: Open-label, block-randomised, comparative, multicentric trial. Setting: Four primary care health facilities, two in urban and two in rural areas of Madang and East Sepik Province, Papua New Guinea.
Participants: Patients of all ages with recurrent uncomplicated malaria Intervention: Random assignment to receive either Cotrifazid, mefloquine or the standard treatment of quinine+sulfadoxine/pyrimethamine (SP).
Outcome measures: Incidence of clinical and laboratory adverse events; rate of clinical and/or parasitological failure at day 14
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 330 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland is the lead sponsor of 22 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All subjects > 6 months of age who presented at the centres and who were diagnosed with malaria (history of fever, OptiMAL® test positive, no other major symptom) and who had already been treated for malaria in the 28 days before, could be included in the study, if the subject or legal guardian (for children) gave informed consent and if the clinician in charge would have given the standard treatment for resistant malaria independent of the study -
Exclusion Criteria:
A subject was not to be included if the clinician preferred to use quinine for whatever reason, if the patient had one of the symptoms or signs of complicated or severe malaria (i.e. history of recent convulsion, any neurological sign or impairment of consciousness, heavy vomiting, haemoglobinuria, respiratory distress, bleeding, circulatory collapse, shock, jaundice, haemoglobin \< 5 g/dl), had contra-indications for mefloquine (history of psychiatric disorder, epilepsy), or was pregnant.
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Clinical treatment failure rate on day 14.
Incidence of adverse events.
Parasitological failure rate on day 14
Fever clearance time
Parasite clearance time
Symptoms clearance time
Occurrence of complications
This study is terminated, as verified in Oct 1999. You cannot join it, but the record below documents what was studied.
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Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland