Monitoring and evaluation of the efficacy and safety of Artesunate-Mefloquine (ASMQ) and Artesunate-Pyronaridine (ASP) for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in Cambodia
Clinical and parasitological efficacy of artesunate-amodiaquine over 28 days in the treatment of uncomplicated falciparum malaria in Cambodia
Ministry of Health
120 participants
Jun 1, 2020
Interventional
Conditions
Summary
This study was to monitor and evaluate the efficacy and safety of Artesunate-Mefloquine (ASMQ) and Artesunate-Pyronaridine (ASP) for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in Cambodia
Eligibility
Inclusion Criteria1
- The study population consisted of patients with uncomplicated P. falciparum or P. vivax malaria attending the study health clinic who are aged between 2-60 years for ASP and 18-60 years for ASMQ. All adult patients were above 18 years, age of majority in this country, signed an informed consent form for participation. Parents or guardians were informed consent on behalf of children who have not reached the age of majority. Children aged from 12 years and age of majority are required to consent for participation by signing an informed assent form.
Exclusion Criteria3
- Pregnancy or lactation
- Severe malaria
- Mixed malaria infection
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Interventions
ASMQ (Artesunate + Mefloquine co-formulated). The adult dose tablet contains 100mg Artesunate plus 220mg Mefloquine and the pediatric tablet contain 55mg Artesunate plus 55 mg Mefloquine. ASP (Artesunate + Pyronaridine/ Pyramax): Adults and children greater than or equal to 20 kg. All doses of medicine will be administered under the supervision of a qualified member of the staff designated by the principal investigator. The study patients will be observed for 30 min after medicine administration for adverse reactions or vomiting. Any patient who vomits during this observation period will be re-treated with the same dose of medicine and observed for an additional 30 min. If the patient vomits again, he or she will be withdrawn and offered rescue therapy. The patients are recommended to stay at the health facility until they complete the treatment course for malaria infection. This surveillance study is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. Eligible patients were treated with a daily dose of 1 tablet containing 135mg amodiaquine 'AQ' and 50mg artesunate 'AS' for the patients with 8-17 kg body weight over 3 days, 1 tablet containing 270mg amodiaquine 'AQ' and 100mg artesunate 'AS' for the patients with 17-35 kg body weight and 2 tablets for the patients above 35 kg body weight over 3 days. In addition, a single oral dose of 15-mg adult dose of Primaquine was given to the patient on the first day of treatment. The blood slide was examined daily until the patient was negative on 2 consecutive days. The patients took each dose of the drug before the health stay, stayed at the study site for the first 3 or 4 days, and returned to the study site weekly over 28 days.
Locations(1)
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ACTRN12622000638730