Measurement of the level of performance of two malaria medicines (artemether-lumefantrine and dihydroartemisinin-piperaquine) for the treatment of uncomplicated malaria caused by malaria parasite called Plasmodium falciparum in Alikadam Upazila (sub-district) and Lama Upazila (subdistrict) of Bandarban district and Baghaichari Upazila (subdistrict) of Rangamati district, Bangladesh.
- Conditions
- Febrile malaria patients aged more than 6 months with confirmed uncomplicated P. falciparum infection.Public Health - EpidemiologyInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12623000239662
- Lead Sponsor
- Ministry of Health and Family Welfare, Bangladesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 360
•age more than 6 months;
•mono-infection with P. falciparum detected by microscopy;
•parasitaemia of 1000/µl to 100,000 asexual forms;
•presence of tympanic temperature greater than or equal to 37.5 °C or history of fever during the past 48 h;
•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;
•informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years;
•informed assent from any minor participant aged from 12 to 18 years; and
•consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under the age of majority years.
•presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
•weight under 5 kg;
•any mixed or mono-infection with other Plasmodium species detected by microscopy;
•presence of severe malnutrition defined as a child aged 6-60 months who has symmetrical edema involving at least the feet and/or has a mid-upper arm circumference < 115 mm)
•presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
•regular medication, which may interfere with antimalarial pharmacokinetics;
•history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
•a positive pregnancy test or breastfeeding; and
•unable to or unwilling to take pregnancy test or to use contraception for married women of child-bearing age.
•minors (below 18 years of age) who have achieved menarche will be excluded from the study.
•Unmarried women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method