Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
ACTIVE
A Double Blind Randomized Controlled Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2012
CompletedFirst Posted
Study publicly available on registry
May 22, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedApril 18, 2013
April 1, 2013
3 months
May 16, 2012
April 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values
8 days
Secondary Outcomes (1)
Mosquitocidal activity
feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding
Study Arms (3)
Artemether-Lumefantrine
ACTIVE COMPARATORArtemether-Lumefantrine + single dose Ivermectin
EXPERIMENTALArtemether-Lumefantrine + repeated dose Ivermectin
EXPERIMENTALInterventions
Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL
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.
Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.
Eligibility Criteria
You may qualify if:
- asymptomatically infected individuals with any P. falciparum parasite density
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre National de Recherche et de Formation sur le Paludisme
Ouagadougou, Burkina Faso
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Teun Bousema
London School of Hygiene and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2012
First Posted
May 22, 2012
Study Start
January 1, 2013
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
April 18, 2013
Record last verified: 2013-04