Adjunctive Ivermectin Mass Drug Administration for Malaria Control

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a cluster-randomized placebo-controlled clinical trial to evaluate the additive benefit of Ivermectin (IVM) (or Placebo) mass drug administration (MDA) to dihydroartemisinin-piperaquine (DP) MDA for malaria control in a moderate to low malaria-endemic setting as an adjunctive strategy to existing programmatic malaria control measures. The regime of DP and IVM will target both human reservoirs of Plasmodium falciparum and the Anopheles gambiae vector respectively, with the aim of interrupting transmission. The trial will be conducted on the Bijagos Archipelago, where islands (clusters) will be randomised to receive seasonal DP and IVM or DP and Placebo MDA. The primary outcome will be the prevalence of infection with Plasmodium falciparum in all age groups detected by nucleic acid amplification testing during the peak malaria transmission season after two years of intervention.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Bandim Health Project; Instituto Nacional de Estudos e Pesquisas, Guinee-Bissau; Medical Research Council Unit, The Gambia; Ministerio de Saude Publica, Guinee-Bissau
• Treatments: Artenimol; Dihydroartemisinin; Ivermectin; Piperaquine

Criteria

Inclusion Criteria:

1. Age over six months to receive dihydroartemisinin-piperaquine

2. Height over 90cm or weight over 15kg to receive ivermectin or placebo

3. Willingness to adhere to trial procedures

4. Individual written, informed consent from the participant or parent/guardian in the case of participants below the age of 18 years (and assent in young people between the ages of 12 and 17 years of age)

Exclusion Criteria:

1. Known severe chronic illness (AIDS, Tuberculosis, chronic malnutrition)

2. Known hypersensitivity to either dihydroartemisinin-piperaquine or ivermectin

3. Pregnancy (any trimester) and breastfeeding (for ivermectin (or placebo)) and pregnancy (first trimester only) (for dihydroartemisinin-piperaquine)

4. Travel to a Loa loa endemic country (eg Central African Republic) (for ivermectin (or placebo))

5. Concomitant drugs that influence cardiac function or affect the corrected QT interval (for dihydroartemisinin-piperaquine)