Optimising Operational Use of Artemether-lumefantrine Comparing 3 Day Versus 5 Day (AL3vs5)
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|ClinicalTrials.gov Identifier: NCT02020330|
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Plasmodium Falciparum Infection||Drug: Artemether-lumefantrine 3 days Drug: Artemether-lumefantrine 5 days||Phase 3|
- The study will be conducted in 6 village health centres in the Mon and Kayin states
- The patient or parent/guardian (in case of minor or under aged) must personally sign and date the latest approved version of the informed consent form before any study specific procedures are performed
- A case record form will be completed for each patient documenting symptoms prior to clinic attendance, concomitant illness, drug history. Height, weight, vital signs and physical examination findings will be recorded.
At enrolment (D0) all patients will have the following samples taken:
- Repeat parasite count (thick and thin films). Treatment should be started without waiting for the result.
- Filter paper blood blots (3 dots on Whatman 3MM filter paper approx 180-300 µL blood) for parasite genotyping (MSP1, MSP2, GLURP in case of recurrence during follow-up)
- Slide microscopy: Thick and thin blood films stained with Giemsa will be read and counts expressed as the number of parasites per 500 white blood cells
- Molecular studies: The samples will be used to detect asexual parasites (blood smear, sensitive PCR), parasite population structure (Sequenom genotyping and sequencing), gametocytes (microscopy). The samples will be stored in a cool box and kept maximum 5 days in the field and will be transported to the local laboratory for processing. Plasma and buffy coat will be separated, frozen and stored. The frozen packed red cells will be transported to the molecular laboratory at MORU, Bangkok, Thailand, for sample processing (DNA extraction, quantitative PCRs).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Randomized Controlled Trial to Evaluate the Effectiveness and Safety of a 3 Day Versus 5 Day Course of Artemether-lumefantrine for the Treatment of Uncomplicated Falciparum Malaria in Myanmar|
|Actual Study Start Date :||November 25, 2013|
|Actual Primary Completion Date :||February 4, 2015|
|Actual Study Completion Date :||March 25, 2015|
Active Comparator: AL3days
Artemether-lumefantrine 3 days
Drug: Artemether-lumefantrine 3 days
One tablet contains 20mg artemether and 120mg lumefantrine. The standard regimen is twice daily for 3 days with a delay of at least 8 hours between the first and second dose. It is dosed by weight categories. One gram of fish oil will be given to half of the participants in the 3 days arm.
Other Name: Coartem®, Novatis, Switzerland
Artemether-lumefantrine 5 days
Drug: Artemether-lumefantrine 5 days
One tablet contains 20mg artemether and 120mg lumefantrine. The experiment regimen is twice daily for 5 days with a delay of at least 8 hours between the first and second dose. It is dosed by weight categories. One gram of fish oil will be given to half of the participants in the 5 days arm.
Other Name: Coartem®, Novartis, Switzerland
- proportion of patients with detectable parasitaemia [ Time Frame: On day 5 and day 7 ]Assessed by sensitive PCR on days 5 and 7 after treatment
- Parasitaemia clearance time [ Time Frame: On day 3 and Day 5 ]Assessed by sensitive PCR on D3 in the 3 day arm and D5 in the 5 day arm
- Gametocyte carriage rates [ Time Frame: Day 7 ]
- artemether-lumefantrine tolerability [ Time Frame: 5 days ]Tolerability of artemether-lumefantrine will be assessed by comparing the proportion of patients with anorexia, nausea, vomiting, abdominal pain and other symptoms of administration between the intervention arm and the control arm
- Comparison of effectiveness [ Time Frame: Day 42 ]Comparison of effectiveness uncorrected and corrected will be assessed by PCR genotyping
- concentrations of lumefantrine [ Time Frame: Day 7 ]
- Haematological recovery rate [ Time Frame: Day 28 ]Assessed by comparing hemoglobin between baseline and after treatment at day 28
- Incidence of vivax malaria relapses [ Time Frame: 42 days ]Assessed by the microscopist find malaria smear positive within the follow up period
- Comparison of addition of food supplement (fish oil) [ Time Frame: day 3 to day 21 ]Assessed by comparing lumefantrine concentration on day 7 and proportion of patients with detectable parasitaemia by qPCR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020330
|Medical Action Myanmar|
|Principal Investigator:||Frank Smithuis, MD||Myanmar Oxford Clinical Research Unit|