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

Phase 1

Completed

• Conditions: Malaria
• Interventions: Drug: Artemether-lumefantrine combination + repeated dose Ivermectin; Drug: Artemether-lumefantrine combination; Drug: Artemether-lumefantrine combination + single dose Ivermectin

• Registration Number: NCT01603251
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-22
• Study Start: 2013-01
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-17
• Last Update Posted: 2013-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artemether-Lumefantrine + repeated dose Ivermectin	Artemether-lumefantrine combination + repeated dose Ivermectin	-
Artemether-Lumefantrine	Artemether-lumefantrine combination	-
Artemether-Lumefantrine + single dose Ivermectin	Artemether-lumefantrine combination + single dose Ivermectin	-

Primary Outcome Measures

Name	Time	Method
Safety	8 days	The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre National de Recherche et de Formation sur le Paludisme; 🇧🇫 Ouagadougou, Burkina Faso