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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02020330 |
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Date of registration:
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30/10/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Optimising Operational Use of Artemether-lumefantrine Comparing 3 Day Versus 5 Day
AL3vs5 |
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Scientific title:
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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 |
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Date of first enrolment:
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November 25, 2013 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02020330 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Myanmar
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Contacts
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Name:
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Frank Smithuis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Myanmar Oxford Clinical Research Unit |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age = 6 year
2. Symptomatic malaria infection, i.e. history of fever or presence of fever >37.5°C
3. Microscopic confirmation of asexual stages of P. falciparum (may be mixed with
non-falciparum species) with parasitaemia PFT=5/500 WBC
4. Written informed consent given to participate in the trial
Exclusion Criteria:
1. Pregnancy or lactation (urine test for ß HCG to be performed on any woman of child
bearing age unless menstruating).
2. Female of 12 to 18 years of age
3. P. falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells
(175,000/µL).
4. 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
5. A full course of artemether-lumefantrine treatment in the previous 28 days
6. Known hypersensitivity to artemisinins - defined as history of erythroderma/other
severe cutaneous reaction, angioedema or anaphylaxis
7. History of splenectomy
Age minimum:
6 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Plasmodium Falciparum Infection
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Intervention(s)
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Drug: Artemether-lumefantrine 5 days
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Drug: Artemether-lumefantrine 3 days
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Primary Outcome(s)
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proportion of patients with detectable parasitaemia
[Time Frame: On day 5 and day 7]
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Secondary Outcome(s)
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Gametocyte carriage rates
[Time Frame: Day 7]
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Incidence of vivax malaria relapses
[Time Frame: 42 days]
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Comparison of addition of food supplement (fish oil)
[Time Frame: day 3 to day 21]
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Parasitaemia clearance time
[Time Frame: On day 3 and Day 5]
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artemether-lumefantrine tolerability
[Time Frame: 5 days]
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Comparison of effectiveness
[Time Frame: Day 42]
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concentrations of lumefantrine
[Time Frame: Day 7]
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Haematological recovery rate
[Time Frame: Day 28]
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Secondary ID(s)
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MOCRU1301
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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