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| Sponsor: | Policlinique Médicale Universitaire |
|---|---|
| Collaborators: |
Papua New Guinea Institute of Medical Research Swiss Tropical Institute |
| Information provided by: | Policlinique Médicale Universitaire |
| ClinicalTrials.gov Identifier: | NCT00322907 |
Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Clinical Malaria |
Drug: Cotrifazid vs mefloquine or quinine+SP |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea |
| Estimated Enrollment: | 330 |
| Study Start Date: | April 2000 |
| Estimated Study Completion Date: | January 2003 |
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
Eligibility| Ages Eligible for Study: | 6 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
-
Contacts and Locations| Papua New Guinea, Madang and East Sepik Province | |
| Health centers | |
| Madang and Maprik, Madang and East Sepik Province, Papua New Guinea | |
| Principal Investigator: | Blaise Genton, MD, PhD | Swiss Tropical Institute |
More Information
| Study ID Numbers: | Fatol 1 |
| Study First Received: | May 5, 2006 |
| Last Updated: | May 5, 2006 |
| ClinicalTrials.gov Identifier: | NCT00322907 History of Changes |
| Health Authority: | Papua New Guinea: Ministry of Health |
|
malaria treatment cotrifazid clinical trial efficacy |
|
Protozoan Infections Anti-Infective Agents Antiprotozoal Agents Coccidiosis Quinine Physiological Effects of Drugs Neuromuscular Agents Malaria Pharmacologic Actions Antimalarials |
Antiparasitic Agents Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Muscle Relaxants, Central Parasitic Diseases Analgesics Peripheral Nervous System Agents Mefloquine Central Nervous System Agents |
