None listed
Conditions
Brief summary
This study aims to assess the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for Plasmodium vivax malaria. The study will be conducted in Nansang Township, Southern- Shan State, Myanmar. This surveillance study 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 artemether-lumefantrine for uncomplicated P. falciparum malaria and chloroquine phosphate for P. vivax and monitored for 28 days. Febrile patients with uncomplicated P. falciparum and P. vivax malaria attending the study clinic, who are aged 6 years and above will be enrolled. Sample Size will be 80 patients for each drug. Clinical and parasitological parameters will be monitored over a 28-days follow- up period for artemether-lumefantrine for uncomplicated P. falciparum malaria and chloroquine phosphate for P. vivax, to evaluate drug efficacy and safety of respective drugs. The study hypothesis is that efficacy of (a) artemether-lumefantrine for uncomplicated P. falciparum malaria in term of adequate clinical and parasitological response is higher than 94 % and (b) chloroquine phosphate for P. vivax malaria in term of adequate clinical and parasitological response is higher than 90 %. The treatments for both malaria infections are still safe.
Interventions
This surveillance study is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum and vivax malaria. The study will be conducted from 01 April 2025 to 31 Mar 2026 in Nansang Township, Southern- Shan State, Myanmar People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with oral administration of artemether-lumefantrine tablets containing 20 mg base of artemether and
This surveillance study is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum and vivax malaria. The study will be conducted from 01 April 2025 to 31 Mar 2026 in Nansang Township, Southern- Shan State, Myanmar People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with oral administration of artemether-lumefantrine tablets containing 20 mg base of artemether and 120 mg base of lumefantrine for uncomplicated Plasmodium falciparum malaria. Dosage will be 4 tablets for adult and 2 tablets for children twice a day and monitored for 28 days. Oral chloroquine with dosage will be 25mg base/kg once a day over 3 days: 10mg/kg/day, 10mg/kg/day, 5mg/kg/day for Plasmodium vivax malaria and monitored for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. On the basis of the results of direct clinical observation 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(s). Polymerase Chain Reaction (PCR) analysis will be used to distinguish between a true recrudescence due to treatment failure and episodes of reinfection for both P. falciparum only.
Sponsors
WHO Mekong Malaria Elimination Program
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. falciparum detected by microscopy (parasitaemia of 500-100,000/µl asexual form detected by microscopy), or 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 18 years of age and • informed assent from any minor participant aged from 12 to 17 years of age.
Exclusion criteria
• presence of signs of severe falciparum malaria according to the definitions of WHO; • mixed or mono-infection with another Plasmodium species detected by microscopy. • 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);
Outcome results
None listed