Mass Drug Administration of Ivermectin and Dihydroartemisinin-piperaquine as an Additional Intervention for Malaria Elimination

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a community-based cluster-randomized trial in which a novel approach to interrupt residual malaria transmission by mass drug administration (MDA) with ivermectin (IVM) combined with dihydroartemisinin-piperaquine (DP) will be tested. This cluster-randomized trial will involve 32 villages in the Upper River Region of The Gambia that will be randomized to MDA with IVM and DP or to standard of care in a ratio 1:1. This trial aims at establishing whether MDA with IVM and DP can reduce or interrupt malaria transmission in medium to low transmission settings by reducing vector survival and the human reservoir of infection. MDA with IVM and DP will be implemented in the intervention villages and all human settlements in the buffer zone, with the aim of minimizing spillover effects. Control clusters will receive standard malaria control interventions as implemented by the National Malaria Control Program. The primary outcomes will be the prevalence of malaria infection determined by molecular methods in all age groups at the peak of the second transmission season (November-December 2019) and the vector's parous rate 7-14 days after MDA.

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

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Imperial College London; Institute of Tropical Medicine, Belgium; Liverpool School of Tropical Medicine; National Malaria Control Programme, The Gambia; Radboud University; University of Durham
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Ivermectin; Piperaquine

Criteria

Inclusion Criteria

• Age/anthropometry

1. For IVM: weight ≥ 15kg or height ≥90 cm;

2. For DP: age > 6 months

• Willingness to comply with trial procedures

• Individual written informed consent obtained at the beginning of the study

Exclusion Criteria:

• Exclusion criteria for both IVM and DP will include the following:

• Known chronic illness (eg HIV, TB, hepatitis and severe malnutrition).

Additionally for IVM:

1. Pregnancy (any trimester) and breast feeding

2. Hypersensitivity to IVM

3. Travel to Loa loa endemic countries (e.g. Central Africa)

Additionally for DP:

1. First trimester pregnancy

2. Hypersensitivity to DP

3. Taking drugs that influence cardiac function or prolong QTc interval