Cotrifazid Safety and Efficacy Against Malaria

• Status: Terminated
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

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 (SP)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland; Policlinique Médicale Universitaire
• Collaborators: Papua New Guinea Institute of Medical Research; Swiss Tropical & Public Health Institute
• Treatments: Isoniazid; Mefloquine; Quinine; Rifampin; Sulfamethoxazole; Trimethoprim

Criteria

Inclusion Criteria:

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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