Efficacy and safety of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum in Dolisie, Republic of Congo
- Conditions
- MalariaInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12616001422415
- Lead Sponsor
- Ministry of Health and Population
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 176
1.age between 6 months and 11 years.
2.mono-infection with P. falciparum detected by microscopy;
3.parasitaemia of 1000–200000/microliter asexual forms;
4.presence of axillary temperature equal to or greater than 37.5 degrees 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 the parent of children
1.presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
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 6-60 months who has a mid-upper arm circumference < 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 a composite primary outcome.<br><br>Enrolled children will be evaluated for parasitological (using microscopy) and clinical responses. Treatment outcomes will be classified according to the WHO protocol 2009[Primary outcome (treatment failures) will be assessed on days 1, 3, 7, 14, 21 and 28 following treatment of artesunate+amodiaquin or artemether+lumefantrine ]
- Secondary Outcome Measures
Name Time Method