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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Centre national de recherche et de formation sur le paludisme; Radboud University
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Ivermectin; Lumefantrine

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).