Comparison of Artemether-Lumefantrine and Dihydroartemisinin-Piperaquine for treatment of uncomplicated malaria in Uganda: evaluation of efficacy, safety, and tolerability
Not Applicable
Completed
- Conditions
- Malaria (P.falciparum)Infections and InfestationsMalaria (P. falciparum)
- Registration Number
- ISRCTN75606663
- Lead Sponsor
- ganda Malaria Surveillance Project (Uganda)
- Brief Summary
2007 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/17525792 2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18545692
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
1. Aged six months to ten years
2. Weight more than 5 kg
3. Fever (more than 37.5°C axillary) or history of fever in the previous 24 hours
4. Provision of informed consent and agreement to follow-up for 42 days
5. Plasmodium falciparum mono-infection
6. Parasite density more than 2000/µl and less than 200,000/µl
Exclusion Criteria
1. Previously enrolled in this study
2. History of serious side effects to study medications
3. Evidence of a concomitant febrile illness
4. Evidence of severe malaria or danger signs
5. Repeated vomiting of study medications on day zero
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Risk of treatment failure unadjusted and adjusted by genotyping at day 42
- Secondary Outcome Measures
Name Time Method <br> 1. Prevalence of fever on days one to three<br> 2. Prevalence of parasitemia on days two and three<br> 3. Change in mean hemoglobin level between days zero and 42 (or day of treatment failure)<br> 4. Prevalence of gametocytes during follow-up<br> 5. Risk of serious adverse events during follow-up<br> 6. Risk of adverse events of moderate or greater severity, at least possibly related to the study medications, excluding patients requiring quinine therapy<br> 7. Selection of molecular markers associated with drug resistance<br>