Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission (ACTIVE)
April 17, 2013 updated by: London School of Hygiene and Tropical Medicine
A Double Blind Randomized Controlled Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
The purpose of this study is to determine the safety and impact of ivermectin, administered as single or repeated dose, in combination with artemether-lumefantrine in reducing the proportion of mosquitoes that survive and become infected after feeding on a blood meal from a malaria-infected individual.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ouagadougou, Burkina Faso
- Centre national de recherche et de formation sur le paludisme
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- asymptomatically infected individuals with any P. falciparum parasite density
Exclusion Criteria:
- age < 15 years or > 25 years
- malaria parasite density ≥ 10,000 parasites/µL
- clinical symptoms indicating severe malaria
- axillary temperature ≥ 37.5°C
- Body Mass Index (BMI) below 18 or above 32 kg/m2
- haemoglobin concentration below 11 g/dL
- taken ivermectin in the last three months
- Loa loa as assessed by questionnaire, clinical examination and parasitological assessments
- for women: pregnancy or lactation
- known hypersensitivity to AL or IVM
- history and/or symptoms indicating chronic illness
- current use of tuberculosis or anti-retroviral medication
- unable to give written informed consent
- unwillingness to participate in two membrane feeding assays
- travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan. If a potential participant has ever visited one or more of these countries, he or she will not be eligible for enrolment.
- history of cardiovascular disease.
- taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes - macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride.
- known disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
- taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Artemether-Lumefantrine
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Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL
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|
Experimental: Artemether-Lumefantrine + single dose Ivermectin
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Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given once together with the first dose of AL.
A placebo is given together with the fifth dose of AL.
|
|
Experimental: Artemether-Lumefantrine + repeated dose Ivermectin
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Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety
Time Frame: 8 days
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The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values
|
8 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mosquitocidal activity
Time Frame: feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding
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Daily mortality rates of (malaria-infected) Anopheles gambiae s.s. and An.
funestus mosquitoes after taking a blood meal 1, 3 or 7 days after initiation of treatment
|
feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Teun Bousema, LSHTM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
May 16, 2012
First Submitted That Met QC Criteria
May 21, 2012
First Posted (Estimate)
May 22, 2012
Study Record Updates
Last Update Posted (Estimate)
April 18, 2013
Last Update Submitted That Met QC Criteria
April 17, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTIVE (Nationwide Children's Hospital Intramural Grant - 292913)
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