Efficacy and safety of dihydroartemisinin-piperaquine (DP) in Pailin, Preah Vihear and Rattanakiri, and artesunate-mefloquine (ASMQ) in Preah Vihear for uncomplicated P. falciparum malaria and chloroquine (CQ) for P.vivax malaria in the above 3 sites, Cambodia, 2009
- Conditions
- MalariaInfection - Other infectious diseases
- Registration Number
- ACTRN12612000183886
- Lead Sponsor
- Institude Paster du Cambodge
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 420
Above 1 year old;
-Mono Infection with P. falciparum or P. vivax;
-Parasitaemia, 1000–200 000 asexual forms per microlitre for P.f and above 250 asexual forms per microlitre for P.v ;
-Axillary temperature greater than 37.5 degree C
-Ability to swallow oral medication;
-Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
-Informed consent from the patient or from a parent or guardian in case of children.
-Presence of general danger signs among children <5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions;
-Mixed species;
-Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhea with dehydration, etc.),
-Known hypersensitivity or allergy to artesunate or mefloquine
-Known psychiatric disorders, e.g. depression or epilepsy
-Anti arrhythmic or others drugs which are known to influence cardiac function
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 42-day cure rate or ACPR (adequate clinical and parasitological response for falciparum cases and 28-day for vivax.<br><br>42-day PCR-corrected ACPR (PCR: polymerase chain reaction, a molecular tool/test to differentiate if the failure is a true resistance or reinfection) for falciparum cases only[at the end of 42-day follow up for falciparum cases and end of 28 days for vivax cases]
- Secondary Outcome Measures
Name Time Method Reported signs and symptoms of adverse effects during the time of drug administration were collected in the case record form. The patients may experience the following adverse effect.<br><br>1 Dizziness 2 Headache 3 Vestige<br>4 Nausea<br>5 Vomiting<br>6 Diarrhea<br>7 Abdomen pain <br>8 Dark Urine[first 3 days after drug administration]