Health Condition 1: null- Uncomplicated Plasmodium falciparum malaria
Conditions
Interventions
Intervention1: Artesunate-Lumefantrine (Fixed-dose combination tablet): 1 tablet at 0 hr, 8 hr, 24 hr, 36 hr, 48 hr and 60 hr
Control Intervention1: Artemether-Lumefantrine (Fixed-dose Combination Tab
Sponsors
Ipca Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate Clinical and Parasitological ResponseTimepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Fever Clearance TimeTimepoint: Day 1, Day 2 and Day 3;Parasite Clearance TimeTimepoint: Day 1, Day 2 and Day 3 | — |
Countries
India
Contacts
Public ContactNitin Chandurkar
Ipca Laboratories Limited
Outcome results
None listed