Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission

NCT ID: NCT01603251

Last Updated: 2013-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-04-30

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Artemether-Lumefantrine

Group Type: ACTIVE_COMPARATOR

Artemether-lumefantrine combination

Intervention Type: DRUG

Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL

Artemether-Lumefantrine + single dose Ivermectin

Group Type: EXPERIMENTAL

Artemether-lumefantrine combination + single dose Ivermectin

Intervention Type: DRUG

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 + repeated dose Ivermectin

Group Type: EXPERIMENTAL

Artemether-lumefantrine combination + repeated dose Ivermectin

Intervention Type: DRUG

Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.

Interventions

Artemether-lumefantrine combination

Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL

Intervention Type: DRUG

Artemether-lumefantrine combination + single dose Ivermectin

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.

Intervention Type: DRUG

Artemether-lumefantrine combination + repeated dose Ivermectin

Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Centre national de recherche et de formation sur le paludisme

OTHER_GOV

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teun Bousema

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

Centre National de Recherche et de Formation sur le Paludisme

Ouagadougou, , Burkina Faso

Countries

Burkina Faso

Other Identifiers

ACTIVE

Identifier Type: -

Identifier Source: org_study_id