Pharmacokinetics and efficacy of dihydroartemisinin-piperaquine in the treatment of uncomplicated falciparum malaria in children in Burkina Faso
- Conditions
- MalariaInfections and Infestations
- Registration Number
- ISRCTN59761234
- Lead Sponsor
- Beijing Holley-Cotec Pharmaceuticals Co. Ltd (China)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 330
On day 0, patients with symptoms suggestive of malaria and a positive screening thick blood smear will be assessed for the following selection criteria by study physicians for appropriate care:
1. Not previously enrolled in this study
2. Aged greater than 6 months
3. Weight greater than 5 kg
4. Fever (greater than 37.5ºC axillary) or history of fever in the previous 24 hours
5. Absence of any history of serious side effects to study medications
6. No evidence of a concomitant febrile illness in addition to malaria
7. Provision of informed consent and ability to participate in 42-day follow-up (patient has easy access to health unit)
8. No history of antimalarial use in the previous two weeks (except for chloroquine)
9. No danger signs or evidence of severe malaria defined as:
9.1. Unarousable coma (if after convulsion, greater than 30 minutes)
9.2. Recent febrile convulsions (within 24 hours)
9.3. Altered consciousness (confusion, delirium, psychosis, coma)
9.4. Lethargy
9.5. Unable to drink or breast feed
9.6. Vomiting everything
9.7. Unable to stand/sit due to weakness
9.8. Severe anaemia (haemoglobin [Hb] less than 5.0 gm/dL)
9.9. Respiratory distress (laboured breathing at rest)
9.10. Jaundice
After going to the laboratory, the subjects will be referred to the study nurse for treatment allocation and treatment with the study medications. Patients must also meet the following criterion:
10. Absence of repeated vomiting of study medications on day 0
Patients will return to the clinic on day 1 and will be excluded from the study if the following inclusion criteria are not met:
11. Plasmodium falciparum mono-infection
12. Parasite density 2000 - 200,000/ul
1. Inhability to participate in 42 days follow up
2. Pregnant women
3. Severe malaria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Determination of the pharmacokinetic profile of piperaquine in children with uncomplicated falciparum malaria<br>2. Assess the efficacy of dihydroartemisinin piperaquine
- Secondary Outcome Measures
Name Time Method