4 ACT for uncomplicated malaria in African childre
- Conditions
- Malaria
- Registration Number
- PACTR2009010000911750
- Lead Sponsor
- Institute Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 0
1. Weight > 5 kg;
2. Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 asexual parasites per µl;
3. Fever (axillary temperature ³37.5 °C) or history of fever in the preceding 24 hours;
4. Haemoglobin value more or equal to 7.0 g/dl;
5. Signed informed consent by the parents or guardians;
6. Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial
1. Participation in any other investigational drug study (antimalarial
or others) during the previous 30 days
2. Known hypersensitivity to the study drugs
3. Severe malaria
4. Danger signs: not able to drink or breast-feed, vomiting (> twice in
24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;
5. Presence of intercurrent illness or any condition (cardiac, renal, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency
6. Severe malnutrition (defined as weight for height <70% of the median
NCHS/WHO reference)
7. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV+ women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method