None listed
Conditions
Brief summary
Title: Efficacy and safety of pyronaridine-artesunate for Plasmodium vivax in Kawthaung – Mawhtaung, Tanintharyi Region and KyaInSeikgyi-Myawaddy, Kayin State in Myanmar Purpose is to assess the efficacy of pyronaridine-artesunate against P. vivax malaria to support updating of the national policy. The study will be conducted from September to December 2018 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-artesunate for uncomplicated P. vivax malaria and monitored for 28 days. Total 140 (70 patients for each study site) will be included. Clinical and parasitological parameters will be monitored over a 42 day follow-up , to evaluate the efficacy of pyronaridine-artesunate .
Interventions
Treating malaria patients with pyronaridine-artesunate combination
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
Treating malaria patients with pyronaridine-artesunate combination 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. For those with body weight 5 to less than 8 kg, 1 sachet each on day1, 2, and 3, for those with body weight 8 kg to less than 15 kg, 2 sachet each on day 1, 2, and 3, for those with 15 kg to less than 20 kg, 3 sachet each on day 1, 2, and 3. For adult Oral tablets containing 180mg/60mg of Pyronaridine tetraphosphate/Artesunate were used. For those with body weight 20 to less than 24 kg, one tablet each on day 1, 2, and 3, for those with 24 kg to less than 45 kg, 2 tablets each on day 1, 2, and 3, for those with 45 kg to less than 65 kg, 3 tablets each on day 1, 2, and 3, and for those with 65 kg and above body weight, 4 tablets each on day 1, 2, and 3 were given. Every first dose of the treatment is given by Team leader of field team, usually Medical Officer, then following dosed are by malaria volunteers. All empty blisters are recollected to monitor the adherence.
Sponsors
Ministry of Health and Sports
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
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. vivax detected by microscopy (parasitaemia > 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 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 • 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