Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in selected districts of Nepal
- Conditions
- uncomplicated falciparum malariaInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12612001038886
- Lead Sponsor
- Ministry of Health and Population, Nepal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 270
Patients above 6 months, except girls between 12-18 years and unmarried women above 18 years
Malaria positive p. falciparum mono-infection with a parasite density of 1'000-100'000 parasites per microliter
Axillary temperature of 37.5 C or greater or history of fever during the past 24 hours
Ability to swallow oral medication
Ability to comply with study procedures
Written informed consent from patient or from parent or leagl guardian in case of children
Presence general danger signs of severe and complicated malaria
Mixed or mono-infection with another Plasmodium species
Severe malnutrition
Febrile conditions due to disease other than malaria
Regular medication, whcih may interfere with antimalarial pharmacokinetics.
History of hypersensitivity reactions to the medicinal products
preganancy or breastfeeding
Girls between 12-18 years, or unamrried women above 18 years
Women unable or unwilling to take contraceptives
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method