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

Malaria Clinical Trial

— ACTIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603251
• Other study ID #: ACTIVE
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 16, 2012
• Last updated: April 17, 2013
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of HealthUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 25 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Artemether-lumefantrine combination
Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL
• Artemether-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.
• Artemether-lumefantrine combination + repeated dose Ivermectin
Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.

Locations

Country	Name	City	State
Burkina Faso	Centre National de Recherche et de Formation sur le Paludisme	Ouagadougou

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Centre National de Recherche et de Formation sur le Paludisme, Burkina Faso, Radboud University

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values	8 days	Yes
Secondary	Mosquitocidal activity	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	feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding	No