Clinical trial NCT01603251: Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
Official title: A Double Blind Randomized Controlled Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malaria
Keywords: transmission
anopheles
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: Centre national de recherche et de formation sur le paludisme
First posted: 2012-05-22
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Safety
timeFrame: 8 days
Secondary outcomes:
measure: Mosquitocidal activity
timeFrame: feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Centre National de Recherche et de Formation sur le Paludisme
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Teun Bousema
role: PRINCIPAL_INVESTIGATOR
References: