Status:
UNKNOWN
Adjunctive Ivermectin Mass Drug Administration for Malaria Control
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Medical Research Council Unit, The Gambia
Ministerio de Saude Publica, Guinee-Bissau
Conditions:
Malaria,Falciparum
Neglected Tropical Diseases
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief 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) M...
Detailed Description
The objectives of this trial are 1. To evaluate the impact of adjunctive IVM to DP MDA on malaria transmission in communities with high ITN coverage. 2. To evaluate the impact of IVM MDA on An. gambi...
Eligibility Criteria
Inclusion
- Age over six months to receive dihydroartemisinin-piperaquine
- Height over 90cm or weight over 15kg to receive ivermectin or placebo
- Willingness to adhere to trial procedures
- 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
- Known severe chronic illness (AIDS, Tuberculosis, chronic malnutrition)
- Known hypersensitivity to either dihydroartemisinin-piperaquine or ivermectin
- Pregnancy (any trimester) and breastfeeding (for ivermectin (or placebo)) and pregnancy (first trimester only) (for dihydroartemisinin-piperaquine)
- Travel to a Loa loa endemic country (eg Central African Republic) (for ivermectin (or placebo))
- Concomitant drugs that influence cardiac function or affect the corrected QT interval (for dihydroartemisinin-piperaquine)
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
24000 Patients enrolled
Trial Details
Trial ID
NCT04844905
Start Date
May 3 2021
End Date
August 1 2023
Last Update
February 24 2022
Active Locations (1)
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1
Bijagos Archipelago (islands)
Bissau, Guinea-Bissau