Malaria
Conditions
Keywords
transmission, anopheles
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.
Interventions
Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL
DRUGArtemether-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.
DRUGArtemether-lumefantrine combination + repeated dose Ivermectin
Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.
Sponsors
Radboud University Medical Center
Centre national de recherche et de formation sur le paludisme
London School of Hygiene and Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 8 days | The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mosquitocidal activity | feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding | Daily mortality rates of (malaria-infected) Anopheles gambiae s.s. and An. funestus mosquitoes after taking a blood meal 1, 3 or 7 days after initiation of treatment |
Countries
Burkina Faso
Outcome results
None listed