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

London School of Hygiene and Tropical Medicine1 site in 1 country120 target enrollmentJanuary 2013

InterventionsArtemether-lumefantrine combination Artemether-lumefantrine combination + single dose Ivermectin Artemether-lumefantrine combination + repeated dose Ivermectin

DrugsArtemether-lumefantrine combination Artemether-lumefantrine combination + single dose Ivermectin Artemether-lumefantrine combination + repeated dose Ivermectin

Overview

Phase: Phase 1
Intervention: Artemether-lumefantrine combination
Conditions: Malaria
Sponsor: London School of Hygiene and Tropical Medicine
Enrollment: 120
Locations: 1
Primary Endpoint: Safety
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

April 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

London School of Hygiene and Tropical Medicine

Responsible Party

Sponsor

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