Cotrifazid Safety and Efficacy Against Malaria
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea |
- 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
| 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 | |
| Health centers | |
| Madang and Maprik, Madang and East Sepik Province, Papua New Guinea | |
| Principal Investigator: | Blaise Genton, MD, PhD | Swiss Tropical & Public Health Institute |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00322907 History of Changes |
| Other Study ID Numbers: | Fatol 1 |
| Study First Received: | May 5, 2006 |
| Last Updated: | May 5, 2006 |
| Health Authority: | Papua New Guinea: Ministry of Health |
Keywords provided by Policlinique Médicale Universitaire:
|
malaria treatment cotrifazid clinical trial efficacy |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Mefloquine Quinine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Muscle Relaxants, Central Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents |
ClinicalTrials.gov processed this record on May 16, 2013