Optimising Operational Use of Artemether-lumefantrine Comparing 3 Day Versus 5 Day
AL3vs5
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
1 other identifier
interventional
150
1 country
1
Brief Summary
This is a randomised two arm study, comparing artemether-lumefantrine 3 days and 5 days treatment. Patients will be randomised in blocks of ten to one of the two treatment arms. The standard regimen is twice daily for three days with a delay of at least eight hours between the first and second doses. A single of primaquine will be given to all patients on the first day of treatment for gametocytocidal activity. The initial treatment will be given under supervision, all other subsequent doses will be given to the patient to the taken at home. Patients will be followed up for nine visits over forty two days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2013
CompletedStudy Start
First participant enrolled
November 25, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2015
CompletedSeptember 20, 2018
September 1, 2018
1.2 years
October 30, 2013
September 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proportion of patients with detectable parasitaemia
Assessed by sensitive PCR on days 5 and 7 after treatment
On day 5 and day 7
Secondary Outcomes (8)
Parasitaemia clearance time
On day 3 and Day 5
Gametocyte carriage rates
Day 7
artemether-lumefantrine tolerability
5 days
Comparison of effectiveness
Day 42
concentrations of lumefantrine
Day 7
- +3 more secondary outcomes
Study Arms (2)
AL3days
ACTIVE COMPARATORArtemether-lumefantrine 3 days
AL5days
EXPERIMENTALArtemether-lumefantrine 5 days
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 6 year
- Symptomatic malaria infection, i.e. history of fever or presence of fever \>37.5°C
- Microscopic confirmation of asexual stages of P. falciparum (may be mixed with non-falciparum species) with parasitaemia PFT≥5/500 WBC
- Written informed consent given to participate in the trial
You may not qualify if:
- Pregnancy or lactation (urine test for β HCG to be performed on any woman of child bearing age unless menstruating).
- Female of 12 to 18 years of age
- P. falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175,000/µL).
- Signs or symptoms indicative of severe malaria including:
- Impaired consciousness (Blantyre Coma Score \<5 or Glasgow Coma Scale \<15)
- Severe anaemia (Hb% \<5 mg/dl)
- Bleeding disorder -evidenced by epistaxis, bleeding gums, frank haematuria, bleeding from venepuncture sites
- Respiratory distress
- Severe jaundice
- Haemodynamic shock
- A full course of artemether-lumefantrine treatment in the previous 28 days
- Known hypersensitivity to artemisinins - defined as history of erythroderma/other severe cutaneous reaction, angioedema or anaphylaxis
- History of splenectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Action Myanmar
Yangon, Burma
Related Publications (1)
Tun KM, Jeeyapant A, Myint AH, Kyaw ZT, Dhorda M, Mukaka M, Cheah PY, Imwong M, Hlaing T, Kyaw TH, Ashley EA, Dondorp A, White NJ, Day NPJ, Smithuis F. Effectiveness and safety of 3 and 5 day courses of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in an area of emerging artemisinin resistance in Myanmar. Malar J. 2018 Jul 11;17(1):258. doi: 10.1186/s12936-018-2404-4.
PMID: 29996844DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Smithuis, MD
Myanmar Oxford Clinical Research Unit
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2013
First Posted
December 24, 2013
Study Start
November 25, 2013
Primary Completion
February 4, 2015
Study Completion
March 25, 2015
Last Updated
September 20, 2018
Record last verified: 2018-09