Treatment of uncomplicated childhood malaria by artemether-lumefantrine (Coartem®) efficacy, effectiveness, safety and genotyping in Tanzania
- Conditions
- Malaria in under five childrenInfections and InfestationsMalaria
- Registration Number
- ISRCTN69189899
- Lead Sponsor
- ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 360
1. Males or females less than five years of age with body weight greater than 5 kg
2. Suffering from acute uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density of 2,000 to 200,000 parasites/µl
3. Presenting with fever (axillary temperature equal to 37.5°C) or having a history of fever in the preceding 24 hours
4. Able to ingest tablets orally (either suspended in water or un-crushed with food)
1. Present with any of the danger signs of severe malaria
2. Signs/symptoms indicating severe/complicated malaria according to World Health Organization (WHO) criteria (WHO definition)
3. Serious gastrointestinal disease, severe malnutrition (Weight-for-Height [W/H] less than 70%) or severe anaemia (haemoglobin less than 5 g/dl)
4. Known hypersensitivity to artemether-lumefantrine
5. Have been treated with any other drugs within eight weeks prior to screening or intend to use other drugs or biologics during the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Polymerase Chain Reaction (PCR)-adjusted parasitological treatment response (cure, treatment failure) on days 14, 28, 42 and 56 after initial treatment, and on days 14, 28 and 42 after retreatment in supervised and unsupervised patients.
- Secondary Outcome Measures
Name Time Method 1. Occurrence of adverse events during 56 and 42 days after initial and retreatment<br>2. Recrudescence after initial and retreatment<br>3. Reinfection after initial treatment