Efficacy and safety of artesunate-mefloquine for the treatment of uncomplicated Plasmodium falciparum malaria in Binh Phuoc and Dak Nong provinces, Viet Nam, in 2019.
World Health Organization
84 participants
Oct 30, 2019
Interventional
Conditions
Summary
Artesunate - Mefloquine is the most current efficacy of antimalarial drugs that has been used in some countries in Asia as Cambodia, Thailand…We here propose an open-labelled clinical trial to assess the efficacy and safety of artesunate - mefloquine for the treatment of uncomplicated falciparum malaria in Dak Nong, Binh Phuoc in Central and Southern Viet Nam, where were confirmed dihydroartemisinin - piperaquine resistance Interventional study for the assessment of drug efficacy and safety over 42 days Patients with acute uncomplicated P. falciparum malaria. Samples size: 84 patients. One tablet contains 100mg of artesunate and 200mg of mefloquine or 25 mg of artesunate and 50 mg of mefloquine for childrens will be administered as a 3-day regimen Dosing will be according to body weight. All patients will have a blood smear examined every 12 hours from D0 – D3 or during the first week by microscopy until parasite clearance. The primary endpoint of the study is day 42 PCR corrected ACPR ( Adequate clinical and parasitological response). The secondary endpoints • The numbers of patients with a positive malaria slide 72 hours after treatment initiation • Fever clearance time and parasite clearance time. • Kaplan Meier analysis over 42 days for recrudescence and reinfections. • Documented AEs and SAEs and relationships to study drugs.
Eligibility
Inclusion Criteria9
- age between 02 to 60 ages;
- mono-infection with P. falciparum detected by microscopy;
- parasitaemia from 500 to 100,000/µl asexual forms;
- presence of axillary temperature greater than or equal to 37.5 °C or history of fever during the past 24 h;
- 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; and
- informed consent from the patient or from a parent or guardian in the case of children.
- informed assent from any minor participant aged from 12 to 18 years; and
- consent for pregnancy testing from female of child-bearing age (defined as age over 12 years and sexually active) and from their parent or guardian if under the age of majority years (18 years old).
Exclusion Criteria11
- presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO
- weight under 5 kg;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe malnutrition defined as a child aged 6-60 months whose weight-for-high is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 115 mm);
- presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- regular medication, which may interfere with antimalarial pharmacokinetics;
- history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
- a positive pregnancy test or breastfeeding; and
- unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active.
- history of hypersensitivity reactions or contraindications to the medicine(s) being tested; and
- Unmarried female age 12 – 18 years old.
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Interventions
To assess the therapeutic efficacy of Artesunate-Mefloquine. The tablet for adults is 100 mg of artesunate and 200 mg of mefloquine; For Children, the tablet is 25 mg of artesunate and 50 mg of mefloquine. The dose will be administered as a 3-day regimen, according to weight (kg) and age (year) as following: . patients from 2 to under 5 years old, corresponding to weighing from 10 to less than 18 kg, taking 25mg / 50mg tablets, total 3 children tablets. . patients from 5 to under 10 years old, corresponding to weight from 18 to less than 30 kg, take 100mg / 200mg tablets, total 3 adult tablets. . patients over 10 years old, corresponding to weighing over 30 kg, taking 200mg / 400mg tablet, total 6 adult tablets. Artesunate – mefloquine will be taken orally with water, once daily for 3 days. Each dose will be administered under supervision by health staff or if not possible monitored at the patient's home. A dose will be repeated in full if vomiting occurs within 30 minutes of administration of the first day. This event will be documented in the case record form (CRF).
Locations(1)
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ACTRN12620001375943