Cotrifazid Safety and Efficacy Against Malaria
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|ClinicalTrials.gov Identifier: NCT00322907|
Recruitment Status : Terminated
First Posted : May 8, 2006
Last Update Posted : May 8, 2006
|Condition or disease||Intervention/treatment||Phase|
|Clinical Malaria||Drug: Cotrifazid vs mefloquine or quinine+SP||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea|
|Study Start Date :||April 2000|
|Study Completion Date :||January 2003|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322907
|Papua New Guinea|
|Madang and Maprik, Madang and East Sepik Province, Papua New Guinea|
|Principal Investigator:||Blaise Genton, MD, PhD||Swiss Tropical & Public Health Institute|