A clinical trial to study the effects of artesunate - lumefantrine combination and artemether - lumefatrine combination in the treatment of uncomplicated Plasmodium falciparum malaria.
- Conditions
- Health Condition 1: null- Uncomplicated Plasmodium falciparum malaria
- Registration Number
- CTRI/2009/091/000434
- Lead Sponsor
- Ipca Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 176
1. Male and female patients with age between 18 to 65 years
2. Patients clinically diagnosed of uncomplicated Plasmodium falciparum malaria with a diagnosis confirmed by positive blood smear with asexual forms of P. falciparum (parasite count between 1000 and 100,000 asexual parasites/µL of blood)
3. Patients with axillary temperature >/= 37.5 °C and/or history of fever during past 24 hours
4. Patients with clinical signs and symptoms of malaria
5. Patients with satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition.
1. Patients with severe malaria as per WHO criteria
2. Patients with febrile disease other than malaria
3. Patients with mixed malarial infection
4. Patients with abnormal heart function including history of QTc prolongation
5. Patients receiving any concomitant medication which may interact with study drugs
6. Patients who had taken full course of antimalarials within previous 3 days
7. Patients with known history of hypersensitivity to any of the study related drugs
8. Pregnant or lactating women
9. Women of child bearing potential
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adequate Clinical and Parasitological ResponseTimepoint: Day 28
- Secondary Outcome Measures
Name Time Method Fever Clearance TimeTimepoint: Day 1, Day 2 and Day 3;Parasite Clearance TimeTimepoint: Day 1, Day 2 and Day 3