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

Information source: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria

Intervention: Artemether-lumefantrine combination (Drug); Artemether-lumefantrine combination + single dose Ivermectin (Drug); Artemether-lumefantrine combination + repeated dose Ivermectin (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: London School of Hygiene and Tropical Medicine

Official(s) and/or principal investigator(s):
Teun Bousema, Principal Investigator, Affiliation: LSHTM


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.

Clinical Details

Official title: A Double Blind Randomized Controlled Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Safety

Secondary outcome: Mosquitocidal activity


Minimum age: 15 Years. Maximum age: 25 Years. Gender(s): Both.


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


- 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).

Locations and Contacts

Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso
Additional Information

Starting date: January 2013
Last updated: April 17, 2013

Page last updated: August 23, 2015

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