Effectiveness of Artemisinin Combination Regimens in Falciparum Malaria (ACT)
Comparing the Effectiveness of 5 Artemisinin Combination Treatment Regimens in the Treatment of Uncomplicated Falciparum Malaria
Sponsor: Disease Control, Department of Health, Myanmar
This PHASE4 trial investigates Uncomplicated Falciparum Malaria and is currently ongoing. Disease Control, Department of Health, Myanmar leads this study, which shows 7 recorded versions since 2008 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.
Study Description(click to expand)Malaria in Myanmar: In Myanmar, malaria is the number one cause of morbidity. According to the Department of Health (DoH) and WHO there are approximately 500,000 patients with malaria each year. About 80% of reported infections are due to Plasmodium falciparum and 20% are due to Plasmodium vivax. This is likely to be a severe underestimation. MSF-Holland alone treats already 250,000 slide positive malaria patients per year in an area of mixed endemicity covering a population of less that 1 million patients out of a total population of 54 million in the country. Chloroquine was the first line treatment for falciparum malaria for the last five decades. In 1996 and 1998 MSF-Holland with support from the Wellcome Trust (Prof N. White) performed studies in the northern and western part of the country, in which very high in-vivo resistance levels to chloroquine and sulfadoxine-pyrimethamine were demonstrated1,2. Combination treatment of mefloquine plus artesunate (loose tablets) \[MA(LT)\]and treatment with dihydroartemisinin-piperaquine (DP) both proved highly efficacious (99-100%)3,4. The studies performed by MSF provided an important component of the evidence used to convince the health authorities that a change of national protocol was needed. In 2001, the DOH of Myanmar changed the national protocol for...
Malaria in Myanmar:
In Myanmar, malaria is the number one cause of morbidity. According to the Department of Health (DoH) and WHO there are approximately 500,000 patients with malaria each year. About 80% of reported infections are due to Plasmodium falciparum and 20% are due to Plasmodium vivax. This is likely to be a severe underestimation. MSF-Holland alone treats already 250,000 slide positive malaria patients per year in an area of mixed endemicity covering a population of less that 1 million patients out of a total population of 54 million in the country.
Chloroquine was the first line treatment for falciparum malaria for the last five decades. In 1996 and 1998 MSF-Holland with support from the Wellcome Trust (Prof N. White) performed studies in the northern and western part of the country, in which very high in-vivo resistance levels to chloroquine and sulfadoxine-pyrimethamine were demonstrated1,2. Combination treatment of mefloquine plus artesunate (loose tablets) \[MA(LT)\]and treatment with dihydroartemisinin-piperaquine (DP) both proved highly efficacious (99-100%)3,4. The studies performed by MSF provided an important component of the evidence used to convince the health authorities that a change of national protocol was needed. In 2001, the DOH of Myanmar changed the national protocol for the treatment of uncomplicated falciparum malaria; a 3 day treatment of mefloquine-artesunate was chosen to become the first line treatment. Artemether-lumefantrine (AL) and DP are also mentioned in the national protocol as effective treatment regimens, but there is a call in the protocol for more research of these treatments.
These changes in policy are a very good step forward and were widely respected. In practice, some problems remain.
MSF has implemented large malaria activities in Myanmar over the past decade. The programme has performed a diagnostic test for malaria for approximately 3,000,000 patients and approximately 1,500,000 patients have been treated with artemisinin combination treatment (ACT).
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Unknown PHASE4
-
Sep 2025 — Present [monthly]
Unknown PHASE4
-
Sep 2024 — Sep 2025 [monthly]
Unknown PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE4
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status PHASE4
▶ Show 2 earlier versions
-
Jun 2018 — Jan 2021 [monthly]
Unknown Status PHASE4
-
Jan 2017 — Jun 2018 [monthly]
Unknown Status PHASE4
First recorded
Dec 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Disease Control, Department of Health, Myanmar
- Mahidol University
- Medecins Sans Frontieres, Netherlands
- University of Oxford
For direct contact, visit the study record on ClinicalTrials.gov .