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

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.

Conditions

• Malaria

Interventions

DRUG

dihydroartemisinin-piperaquine (DP)

DP will be available as tablets of 320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet. Administration of a full course of DP will be done as per manufacturer's guidelines once daily for 3 days and according to body weight. DP will be taken orally with water and without food

DRUG

ivermectin (IVM)

IVM will be available as tablets of 3mg or 6mg strength. It will be given at 300-400μg/kg/day over 3 days (to the nearest whole tablet). IVM will also be taken on an empty stomach with water

OTHER

standard malaria control interventions only

this is the standard malaria control interventions in the Gambia

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• National Malaria Control Programme, The Gambia

  collaborator OTHER_GOV

• Liverpool School of Tropical Medicine

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• University of Durham

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Umberto D'alessandro, MD, PhD · MRC @ LSHTM

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-08-11

Primary Completion

2019-12-31

Completion

2021-07-31

Countries

• The Gambia

Study Locations