Efficacy and safety of artemether-lumefantrine (AL) combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria in 4 sites in India Annuppur district, Madhya Pradesh, Jhabua district, Madhya Pradesh, Bastar district, Chhattisgarh and Palamudistrict, Jharkhand
- Conditions
- MalariaInfection - Other infectious diseases
- Registration Number
- ACTRN12614000765628
- Lead Sponsor
- Indian Council of Medical Research, Ministry of Health & Family welfare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 352
Age between 6 months to 60 years ; Mono infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection), parasitaemia between 1000 and 100000 microliters of asexual forms; measured temperature (depending on method of measurement) or history of fever within previous 24 hours; ability to swallow oral medication; ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and the absence of severe malnutrition.
Signs and symptoms of severe or complicated malaria according to the definitions of WHO; mixed or mono-infection with another Plasmodium species detected by microscopy; presence of severe malnutrition; febrile conditions due to diseases other than malaria or other know underlying chronic or severe diseases; regular medication which interferes with antimalarial pharmacokinetics; history of hypersensitivity reactions or contraindications to the medicine(s) being tested; positive pregnancy test or breastfeedings; unable to or unwilling to use contraception, including abstinence, for women of child-bearing age and who are sexually active.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method