Efficacy and safety of Artesunate+Amodiaquine and Artemether+Lumefatrine for the treatment of uncomplicated Plasmodium falciparum malaria in children in Saclepea-Mahn Comprehensive Health Center (Saclepea-Mahn District, Nimba County), Rennie Hospital (Kakata District, Margibi County) and Sinje Health Center (Garwula District, Cape Mount County and Bensonville Hospital-Montserrado County) in Liberia
- Conditions
- MalariaInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12617001064392
- Lead Sponsor
- Ministry of Health of Liberia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 528
1.age 6-59 months;
2.mono-infection with P. falciparum detected by microscopy;
3.parasitaemia of 2000–200000/µl asexual forms;
4.presence of axillary or tympanic temperature greater or equal to 37.5 degree centigrade or history of fever during the past 24 h
5.ability to swallow oral medication;
6.ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
7.informed consent from a parent or guardian of children aged 6-59 months;
8.Patients living within 5 km radius of the health facility
1.Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
2.Weight under 5 kg;
3.Mixed or mono-infection with another Plasmodium species detected by microscopy;
4.Presence of severe malnutrition defined as a child aged 6-59 months whose mid-upper arm circumference less than 115 mm);
5.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);
6.Regular medication, which may interfere with antimalarial pharmacokinetics;
7.History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent of treatment failures (early treatment failure + late clinical failure +late parasitological failure). This is composite primary outcome.<br><br>Enrolled patients will be assessed for parasitological and clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol. [On days 0,1,2,3,7,14,21 and 28]
- Secondary Outcome Measures
Name Time Method