Status:
TERMINATED
Cotrifazid Safety and Efficacy Against Malaria
Lead Sponsor:
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Collaborating Sponsors:
Papua New Guinea Institute of Medical Research
Swiss Tropical & Public Health Institute
Conditions:
Clinical Malaria
Eligibility:
All Genders
6+ years
Phase:
PHASE2
Brief Summary
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 (...
Detailed Description
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 Gu...
Eligibility Criteria
Inclusion
- 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
- 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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Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
End Date :
January 1 2003
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00322907
Start Date
April 1 2000
End Date
January 1 2003
Last Update
May 8 2006
Active Locations (1)
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1
Health centers
Madang and Maprik, Madang and East Sepik Province, Papua New Guinea