Malaria Infections and Infestations Malaria
Conditions
Interventions
Patients are given dihydroartemisin piperaquine once daily for three days. Treatment is weight based and directly observed by the study nurse. The follow up duration is 42 days.
The study is a one ar
Sponsors
Beijing Holley-Cotec Pharmaceuticals Co. Ltd (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Inhability to participate in 42 days follow up 2. Pregnant women 3. Severe malaria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Determination of the pharmacokinetic profile of piperaquine in children with uncomplicated falciparum malaria 2. Assess the efficacy of dihydroartemisinin piperaquine | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Risk of recurrent malaria* 2. Risk of clinical and parasitological treatment failure* 3. Prevalence of fever (defined as both subjective fever in the previous 24 hours and measured axillary temperature greater than 37.5ºC) on follow-up days 1, 2, and 3 4. Prevalence of parasitaemia on follow-up days 2 and 3 5. Change in mean haemoglobin from day 0 to 42 (or day of rescue therapy for patients classified as late clinical failure [LCF] or late parasitological failure [LPF]) 6. Prevalence of gametocytaemia on follow-up days 2, 3, 7, 14, 21 and 28 7. Change in the prevalence of molecular markers possibly associated with drug resistance on day 0 or the day of recurrent parasitaemia, including polymorphisms in Plasmodium falciparum chloroquine resistance transporter (Pfcrt) and Plasmodium falciparum multidrug-resistance (Pfmdr1) genes 8. In vitro sensitivity to antimalarial drugs *Risks will be estimated using the Kaplan-Meier product limit formula based on a modified intention-to-treat analysis. | — |
Countries
Burkina Faso, Thailand
Outcome results
None listed