CTRI/2009/091/000434
Completed
Phase 3
Comparative evaluation of efficacy and safety of artesunate-lumefantrine vs. artemether-lumefantrine fixed dose combination in the treatment of uncomplicated Plasmodium falciparum malaria.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Uncomplicated Plasmodium falciparum malaria
- Sponsor
- Ipca Laboratories Limited
- Enrollment
- 176
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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