Therapeutic efficacy testing of drug
- Conditions
- Malaria
- Registration Number
- PACTR201709002064150
- Lead Sponsor
- ational Malaria Elimination Programme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
Patients were included in the study if they satisfied the following criteria: Age 6 - 59 months, History of fever / presence of fever (temp >/= 37.5oC), Mono Plasmodium falciparum infection with parasitemia of 2,000 - 200,000 asexual forms per mL and Written informed consent, including readiness to comply with follow up visits by the child's parent or guardian.
Patients were excluded from the study if they had any of the following: Signs of severe malaria or other danger signs, such as: 1. Hyperparasitaemia >200,000 2. Altered consciousness 3. Inability to sit or stand unsupported 4. Severe anaemia (Hb </= 5 g/dL) 5. Convulsions 6. Shock (systolic BP < 50 mmHg, and or presence of cold clammy extremities, fast thready pulses) 7. Inability to drink or breastfeed 8. Vomiting everything, Severe malnutrition, History of allergy to test drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Early treatment failure;Late clinical failure`;Late parasitological failure;Adequate clinical and parasitological response
- Secondary Outcome Measures
Name Time Method Parasites and fever clearance times;Gametocyte carriage