A Phase 3 interventional study of Artemether-lumefantrine 3 days and Artemether-lumefantrine 5 days in Plasmodium Falciparum Infection, sponsored by University of Oxford. Completed at 1 site in Myanmar. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2018-09-20.
Sponsored by University of Oxford · Phase 3, Interventional, and Treatment
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.
At enrolment (D0) all patients will have the following samples taken:
Laboratory procedures
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 150 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Signs or symptoms indicative of severe malaria including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Artemether-lumefantrine 3 days
Drug: Artemether-lumefantrine 3 days
Artemether-lumefantrine 5 days
Drug: Artemether-lumefantrine 5 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.
Also known as: Coartem®, Novatis, Switzerland
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.
Also known as: Coartem®, Novartis, Switzerland
proportion of patients with detectable parasitaemia
Assessed by sensitive PCR on days 5 and 7 after treatment
Time frame: On day 5 and day 7
Parasitaemia clearance time
Assessed by sensitive PCR on D3 in the 3 day arm and D5 in the 5 day arm
Time frame: On day 3 and Day 5
Gametocyte carriage rates
Time frame: Day 7
artemether-lumefantrine tolerability
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
Time frame: 5 days
Comparison of effectiveness
Comparison of effectiveness uncorrected and corrected will be assessed by PCR genotyping
Time frame: Day 42
concentrations of lumefantrine
Time frame: Day 7
Haematological recovery rate
Assessed by comparing hemoglobin between baseline and after treatment at day 28
Time frame: Day 28
Incidence of vivax malaria relapses
Assessed by the microscopist find malaria smear positive within the follow up period
Time frame: 42 days
Comparison of addition of food supplement (fish oil)
Assessed by comparing lumefantrine concentration on day 7 and proportion of patients with detectable parasitaemia by qPCR
Time frame: day 3 to day 21
Ran from Nov 2013 to primary completion in Feb 2015, 14 months.
Of 23 phase 3 interventional studies under Malaria, Falciparum, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 28. This study's 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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