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 was to assess the efficacy and safety of dihydroartemisinin-piperaquine (DP) and artesunate-mefloquine (ASMQ) for the treatment of uncomplicated Plasmodium falciparum malaria in Preah Vihear and only DP in Pailin and Rattanakiri provinces, and Chloroquine (CQ) in these three sites in Cambodia. The WHO 28-day and 42-day in vivo protocol was used. Patients with uncomplicated P.f or P.v malaria who met the study inclusion criteria were enrolled and treated on site with DP or ASMQ or CQ 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), artesunate-mefloquine (ASMQ) and Chloroquine (CQ). One group was treated with DP daily over 3 days, and another group was treated with ASMQ daily over 3 days for uncomplicated Plasmodium falciparum malaria. 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 based on the weight group
ASMQ (oral tablet) with AS at a dose of 11-
Study Drugs were dihydroartemisinin-piperaquine (DP), artesunate-mefloquine (ASMQ) and Chloroquine (CQ). One group was treated with DP daily over 3 days, and another group was treated with ASMQ daily over 3 days for uncomplicated Plasmodium falciparum malaria. 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 based on the weight group ASMQ (oral tablet) with AS at a dose of 11-14 mg/kg and with MQ at a dose of 22-28 mg/kg daily based on the weight group CQ (oral tablet) at 10mg/kg on Day1, 10mg/kg on Day2 and 5 mg/kg on Day3 based on the weight group
Sponsors
Institude Paster du Cambodge
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-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.
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