None listed
Conditions
Brief summary
This study is an open prospective evaluation of clinical and parasitological responses to directly observed treatment of patients with uncomplicated falciparum and vivax malaria who meet the study inclusion criteria. They will be treated on site with pyronaridine-artesunate, and monitored for 42 days for falciparum and 28 days for vivax. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. With the results of these assessments, the patients will be classified as having therapeutic failure (early or late) or an adequate response. The proportion of patients experiencing therapeutic failure during the follow-up period will be used to estimate the efficacy of the study drug. PCR analysis will be used to distinguish between a true recrudescence due to treatment failure and episodes of reinfection for uncomplicated P. falciparum and P. vivax malaria.
Interventions
All P.f & P.v partients will receive artesunate and pyronaridine.
One oral tablet of the drug contains 60mg artesunate+ 180mg pyronaridine. Drug will be given under supervised treatment according to the following dose based on body weight:
20kg to less than 24 kg = 1 tablet daily for 3 days
24 kg to less than 45 kg = 2 tablets daily for 3 days
45 kg to less than 65 kg = 3 tablets daily for 3 days
Equal or more than 65 kg = 4 tablets daily for 3 days
Oral Primaquine tablet will be administere
All P.f & P.v partients will receive artesunate and pyronaridine. One oral tablet of the drug contains 60mg artesunate+ 180mg pyronaridine. Drug will be given under supervised treatment according to the following dose based on body weight: 20kg to less than 24 kg = 1 tablet daily for 3 days 24 kg to less than 45 kg = 2 tablets daily for 3 days 45 kg to less than 65 kg = 3 tablets daily for 3 days Equal or more than 65 kg = 4 tablets daily for 3 days Oral Primaquine tablet will be administered as a single 15-mg adult dose (0.25 mg base/kg) for P. falciparum cases, and once daily (0.25 base/kg) for 14 days for G6PD normal P. vivax cases.
Sponsors
Ministry of Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adults and children more than or equal to 7 years old and more than or equal to 20 kg body weight except unmarried females between 12 and 18 years old (potential unpredicted pregnancy); - Slide-confirmed mono-infection with P. falciparum or P. vivax; - P. falciparum parasitaemia of 250 to 100,000 per µl asexual forms; - P. vivax parasitaemia of 250 to 60,000 per µl asexual forms - presence of axillary equal to or more than 37.5 °C or history of fever during the past 24 hours - ability to swallow by mouth 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 adult patients, and from a parent or guardian in the case of children aged less than 18 years; - informed assent from any minor participant aged 12 to 18 years; and - consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years.
Exclusion criteria
- presence of general danger signs in children aged under 5 years or signs of severe falciparum or vivax malaria according to the definitions of WHO ; - Children less than 7 years old and less than 20 kg body weight - mixed or mono-infection with another Plasmodium species detected by microscopy; - presence of severe malnutrition (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 110 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); - glucose-6-phosphate dehydrogenase deficiency for patient treated with 14-day primaquine - unmarried women 12 to 18 years old; - a positive pregnancy test or breastfeeding; - unable to or unwilling to take a pregnancy test or unwilling to take pregnancy test or contraceptives (for women of child-bearing age).
Outcome results
None listed