Efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated Plasmodium falciparum malaria in Gia Lai province, Viet Nam in 2022.
World Health Organization
42 participants
Nov 15, 2022
Interventional
Conditions
Summary
The guidelines for malaria diagnosis and treatment in Vietnam was revised and issued in June 2020. Malaria diagnois and treatment are being provided free of charge in Vietnam. First line treatment of falciparum malaria is dihydroartemisinin-piperaquine (DHA-PIP) or artesunate-pyronaridine.We here propose an open-labelled clinical trial to assess the efficacy and safety of artesunate -pyronaridine for the treatment of uncomplicated falciparum malaria in Gia Lai province in 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: 42 patients. One tablet contains 60 mg of artesunate and 180 mg of pyronaridine 3-day regimen Dosing will be according to body weight. All patients will have a blood smear examined every 24 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. Note: Malaria diagnosis and treatment is a term agreed to be used by the Ministry of Health of Vietnam.
Eligibility
Inclusion Criteria19
- To assess the therapeutic efficacy and safety of artesunate-pyronaridine
- age between 07 to 60 ages;
- mono-infection with P. falciparum detected by microscopy;
- parasitaemia of 500 – 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 > 12 years and sexually active) and from their parent or guardian if under the age of majority years (18 years old).
- To assess the therapeutic efficacy and safety of chloroquine
- age between 02 to 60 ages;
- mono-infection with P. vivax detected by microscopy;
- parasitaemia of 250 /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;
- 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.
Exclusion Criteria9
- presence of severe malaria according to the definitions of WHO ;
- weight under 20 kg with P. falciparum patients;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- 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;
- 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
For the treatment of uncomplicated P. falciparum malaria: Artesunate-pyronaridine (Pyramax®, Shin Poong Pharmaceuticals). One tablet contains 60mg artesunate+ 180mg pyronaridine. Dosing will be according to body weight Pyronaridine-artesunate will be taken orally with water, once daily for 3 days. Each dose will be administered under supervision in the clinic or if not possible by a home visitor to the patient’s home. A dose will be repeated in full if vomiting occurs within 30 minutes of administration of the first day of administration only. Weight: 20-<24kg, Daily dose: Pyronaridine (PYR) 180mg+artesunate (AS) 60mg, Number of tablets: 1 Weight: 24-<45kg, Daily dose:PYR 360mg+AS 120mg, Number of tablets: 2 Weight: 45-<65kg, Daily dose:PYR 540mg+AS 180mg, Number of tablets: 3 Weight: >65kg, Daily dose: PYR 720mg+AS 240mg, Number of tablets: 4
Locations(1)
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ACTRN12622001407785