None listed
Conditions
Brief summary
This study was a one-arm prospective evaluation of the clinical and parasitological responses to directly observed treatment for uncomplicated falciparum and vivax malaria. The objective is to assess the efficacy and safety of dihydroartemisinin-piperaquine (DP) and atovaquone-proguanil (AP) for the treatment of uncomplicated Plasmodium falciparum malaria in 2 sites Pailin and Pursat, and chloroquine (CQ) for Plasmodium vivax in Pailin, Cambodia. The WHO 28-day and 42-day in vivo protocol was used. Patients with uncomplicated P.f or P.v malaria who meet the study inclusion criteria were enrolled and treated on site with DP or AP and monitored weekly for 28 days for P.v cases and 42 days for P.f cases. The follow-up consists of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. On the basis of the results of these assessments, the patients were classified as having therapeutic failure (early or late) or an adequate response. The proportion of patients experiencing therapeutic failure during the follow-up period were used to estimate the efficacy of the study drug. PCR analysis were used to distinguish between a true recrudescence or reinfection. The results of this study are being used to assist the Ministry of Health of Cambodia in assessing the current national treatment guidelines for uncomplicated P. f and P.v malaria.
Interventions
Study drugs were dihydroartemisinin-piperaquine (DP), atovaquone-proguanil (AP) and Chloroquine (CQ). One group was treated with DP over 3 days , another group was treated with AP over 3 days for P.f cases. In a separate group of patients with P. vivax malaria, CQ alone was used for treatment.
DP (oral tablet) with a dose of 4mg/kg for D and 20mg/kg for P daily for 3 days
AP (oral tablet) with a dose of A at 15mg/kg and P at 6mg/kg daily for 3 days
CQ (oral tablets) at 10mg/kg on Day 1, 10mg
Study drugs were dihydroartemisinin-piperaquine (DP), atovaquone-proguanil (AP) and Chloroquine (CQ). One group was treated with DP over 3 days , another group was treated with AP over 3 days for P.f cases. In a separate group of patients with P. vivax malaria, CQ alone was used for treatment. DP (oral tablet) with a dose of 4mg/kg for D and 20mg/kg for P daily for 3 days AP (oral tablet) with a dose of A at 15mg/kg and P at 6mg/kg daily for 3 days CQ (oral tablets) at 10mg/kg on Day 1, 10mg/kg on Day 2and 5 mg/kg on Day3.
Sponsors
Global Fund For Malaria
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Above 2years old (all age groups); -Mono Infection with P. falciparum or P. vivax; -Parasitaemia, 1000–200 000 asexual forms per microlitre ; -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.
Exclusion criteria
-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
Outcome results
None listed