Adjunctive Ivermectin Mass Drug Administration for Malaria Control

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.

Conditions

• Malaria,Falciparum
• Neglected Tropical Diseases
• Strongyloidiasis
• Lymphatic Filariasis
• Scabies
• Hook Worm
• Soil Transmitted Helminths

Interventions

DRUG

Ivermectin

Ivermectin will be given as tablets of 3 or 6mg. It will be given at 300-400μg/kg/day for 3 days (to the nearest whole tablet) each month for 3 months. It will be taken on an empty stomach with water.

DRUG

Placebo

Placebo will be given as tablets of 3 or 6mg (identical to Ivermectin in colour, size, shape and packaging). It will be given at 300-400μg/kg/day for 3 days (to the nearest whole tablet) each month for 3 months. It will be taken by mouth with water and without food.

DRUG

Dihydroartemisinin-piperaquine

Dihydroartemisinin-piperaquine will be given as tablets of 320/40mg (adult) and 160/20mg (child) piperaquine/dihydroartemisinin per tablet. Administration of a full course of dihydroartemisinin-piperaquine will be given in accordance with the manufacturer's guidelines once daily for 3 days each month for 3 months according to body weight. Dihydroartemisinin-piperaquine will be taken by mouth with water and without food.

Sponsors & Collaborators

• Medical Research Council Unit, The Gambia

  collaborator OTHER

• Ministerio de Saude Publica, Guinee-Bissau

  collaborator UNKNOWN

• Bandim Health Project

  collaborator OTHER

• Instituto Nacional de Estudos e Pesquisas, Guinee-Bissau

  collaborator UNKNOWN

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Anna R Last, MBChB PhD · London School of Hygiene and Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-03

Primary Completion

2023-03-31

Completion

2023-08-31

Countries

• Guinea-Bissau

Study Locations