None listed
Conditions
Brief summary
Title: Efficacy and safety of pyronaridine-artesunate combination for the treatment of uncomplicated Plasmodium falciparum malaria in Kawthaung – Mawhtaung, Tanintharyi Region and Kyainseikkyi-Myawaddy, Kayin State in Myanmar Purpose is to assess the efficacy of pyronaridine- artesunate (an alternative artemisinin-based combination treatment) for the treatment of uncomplicated Plasmodium falciparum malaria to support updating of the national policy. The study will be conducted at Kawthaung –Mawhtaung, Tanintharyi Region and Kyainseikkyi-Myawaddy, Kayin State, during May to December 2017 in both study sites. It is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with pyronaridine-atesunate for uncomplicated P. falciparum malaria and monitored for 42 day. Total 140 (70 patients at each study site) will be included. Clinical and parasitological parameters will be monitored over a 42 day follow-up period for Pf to evaluate drug efficacy of pyronaridine-artesunate combination.
Interventions
Treat the patients with
Pyronaridine-artesunate, a fixed dose of tablet formula with 180 mg pyronaridine tetraphosphate and 60 mg artesunate, and granules for oral suspension formula for children with 60 mg pyronaridine tetraphosphate and 20 mg artesunate, will be administered as a weight per dose regimen. The correct drug dosage will be determined from the dosing chart as follow;
For children
Sachets of Granules for oral suspension containing 60mg/20mg of Pyronaridine tetraphosphate/Artesunate
Treat the patients with Pyronaridine-artesunate, a fixed dose of tablet formula with 180 mg pyronaridine tetraphosphate and 60 mg artesunate, and granules for oral suspension formula for children with 60 mg pyronaridine tetraphosphate and 20 mg artesunate, will be administered as a weight per dose regimen. The correct drug dosage will be determined from the dosing chart as follow; For children Sachets of Granules for oral suspension containing 60mg/20mg of Pyronaridine tetraphosphate/Artesunate Body weight (kg) Number of Sachets Day 0 Day 1 Day 2 5-<8kg 1 1 1 8-<15kg 2 2 2 15-<20kg 3 3 3 For adult Tablets containing 180mg/60mg of Pyronaridine tetraphosphate/Artesunate Body weight (kg) Number of tablets Day 0 Day 1 Day 2 20-<24kg 1 1 1 24-<45kg 2 2 2 45-<65kg 3 3 3 = or >65kg 4 4 4 To monitor the adherence, first dose of ACT is given as directly observed treatment (DOT), then following doses are by malaria health volunteers and empty blisters are recollected and checked.
Sponsors
Ministry of Health and Sports
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• patients aged 6 year and above • 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; • informed consent from the patient or from a parent or guardian in the case of children aged less than age of majority; • informed assent from any minor participant aged from 12 to age of majority years; and • consent for pregnancy testing from female of child-bearing age(defined as age > 17 years and sexually active).
Exclusion criteria
• Presence signs of severe falciparum malaria according to the definitions of WHO as follow; • mixed or mono-infection with another Plasmodium species detected by microscopy; • female aged from 12 and 17 years; • Body weight under 20 kg; • presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea 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(defined as age > 12 years and sexually active).
Outcome results
None listed