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

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.

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).