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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4939 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-11

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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The hypothesis of this project is that mass drug administration (MDA) with ivermectin (IVM) and dihydroartemisinin-piperaquine (DP) can reduce or interrupt malaria transmission in medium to low transmission settings by reducing vector survival and the human reservoir of infection. The research questions include the following:

1. Will MDA with IVM plus DP (3 rounds per transmission season) in communities with high coverage of vector control interventions further reduce malaria transmission (up to local elimination)?
2. Will MDA with IVM suppress the vector population?
3. What is the most socially acceptable and sustainable way of achieving and maintaining high coverage of MDA with IVM and DP, and of embedding it within local communities and stakeholders?
4. What is the impact of MDA with IVM on prevalence of ectoparasites and helminths
5. What is the cost and cost-effectiveness of this intervention compared to standard malaria control measures?

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Malaria prevalence will be determined by technicians blinded to the treatment arm

Study Groups

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intervention: IVM and DP

Mass Drug Administration with ivermectin (IVM) and dihydroartemisinin-piperaquine (DP) will be given to participants in the intervention villages plus the NMCP standard malaria control intervention

Group Type EXPERIMENTAL

dihydroartemisinin-piperaquine (DP)

Intervention Type DRUG

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

ivermectin (IVM)

Intervention Type DRUG

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

standard malaria control interventions only

Intervention Type OTHER

this is the standard malaria control interventions in the Gambia

control: standard malaria control intervetions

Participants in the control clusters will receive only standard malaria control interventions such as Artemether Lumefantrine, LLINs, IRS, SMC and IPTp as implemented by the National Malaria Control Program (NMCP) of the Gambia

Group Type ACTIVE_COMPARATOR

standard malaria control interventions only

Intervention Type OTHER

this is the standard malaria control interventions in the Gambia

Interventions

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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

Intervention Type 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

Intervention Type DRUG

standard malaria control interventions only

this is the standard malaria control interventions in the Gambia

Intervention Type OTHER

Eligibility Criteria

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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

* 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

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes