Clinical investigation of in-vivo susceptibility of Plasmodium falciparum to artesunate in Western Cambodia (study 2)
Not Applicable
Completed
- Conditions
- Acute falciparum malariaInfections and InfestationsPlasmodium falciparum malaria
- Registration Number
- ISRCTN15351875
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Children greater than 6 years old and adults (either sex) presenting with acute falciparum malaria will be eligible for this study provided that:
1. They or their parents/guardians give fully informed consent
2. They have not received antimalarial drugs in the previous 48 hours
3. Plasmodium falciparum parasitaemia exceeds 10,000 /uL
4. They agree to seven days of hospitalisation
Exclusion Criteria
1. Pregnancy
2. Microscopy indicates a mixed infection
3. History of allergy to artesunate or mefloquine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parasite clearance times in relation to artesunate/dihydroartemisinin (DHA) plasma concentration (PK/PD) (time point: 63 days).
- Secondary Outcome Measures
Name Time Method 1. Cure rates (time point: 63 days)<br>2. In vitro sensitivity of P. falciparum to artesunate measured prior to treatment (time point not applicable)<br>3. Molecular markers of drug resistance measured prior to treatment (time point not applicable)