Pilot Study: Comparison of the efficacy of artemisinin plus piperaquine (Artequick), artesunate plus amodiaquine (Coarsucam) and artesunate plus azithromycin for the treatment of Plasmodium falciparum malaria in Vietnam
Phase 3
Recruiting
- Conditions
- Malaria infectionInfection - Other infectious diseases
- Registration Number
- ACTRN12609000816257
- Lead Sponsor
- Australian Army Malaria Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
(i) Sex: male or female
(ii) Age: Between 5 years and 65 years old
(iii) Falciparum malaria with parasitaemia between 200 and 200,000 parasites/uL of blood
(iv) Is willing to give small amounts of blood via finger prick and phlebotomy
(vi) Written informed consent and agreed to treatment follow-up for a total of 42 days
Exclusion Criteria
(i) Severe/cerebral malaria or history of another serious medical disease
(ii) Prior treatment with an artemisinin drug within the previous 7 days
(iii) Pregnancy and lactating
(iv) Inability to communicate well with the investigator (poor mental development or evidence of psychiatric disorder)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the therapeutic efficacy and tolerability of three artemisinin-based combination therapies (ACTs); artemisinin plus piperaquine (Artequick), artesunate plus amodiaquine (Coarsucam) and artesunate plus azithromycin for the treatment of uncomplicated Plasmodium falciparum in an area of central Vietnam. The efficacy of the three ACTs are compared by the number of patients cured of their infection over a 42-day follow-up period. Recrudescences of infection will be determined by Polymerase Chain Reaction (PCR) analysis.[Parasitaemia clearance will be determined from blood smears collected 12 hourly after starting treatment by microscopic analysis until negative and at weeks 1, 2, 3, 4, 5, and 6 after commencement of treatment. Blood spots for PCR analysis will also be collected before treatment and at weeks 1, 2, 3, 4, 5, and 6 after starting treatment.]
- Secondary Outcome Measures
Name Time Method To determine the in vitro susceptibility and molecular genotyping of Plasmodium falciparum isolates collected from malaria patients at Phuoc Chien Commune, central Vietnam. In vitro drug susceptibility testing will be carried out on a blood samples collected from the patients before starting treatment using the field microtechnique candle-jar method and molecular genotyping of Plasmodium falciparum isolates will be carried out using Multiplex PCR-Restriction Fragment Length Polymorphism (RFLP) analysis.[In vitro minimum inhibitory concentration (MIC) of several antimalarial drugs, Plasmodium falciparum chloroquine resistant transporter gene (Pfcrt) and Plasmodium falciparum multidrug-resistant 1 gene (Pfmdr1) will be assessed on a blood sample collected before starting treatment.]