- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03576313
Mass Drug Administration of Ivermectin and Dihydroartemisinin-piperaquine as an Additional Intervention for Malaria Elimination (MASSIV)
Study Overview
Status
Conditions
Detailed Description
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:
- 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)?
- Will MDA with IVM suppress the vector population?
- 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?
- What is the impact of MDA with IVM on prevalence of ectoparasites and helminths
- What is the cost and cost-effectiveness of this intervention compared to standard malaria control measures?
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Basse Santa Su, Gambia
- Basse Villages
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Age/anthropometry
- For IVM: weight ≥ 15kg or height ≥90 cm;
- 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:
- Pregnancy (any trimester) and breast feeding
- Hypersensitivity to IVM
- Travel to Loa loa endemic countries (e.g. Central Africa)
Additionally for DP:
- First trimester pregnancy
- Hypersensitivity to DP
- Taking drugs that influence cardiac function or prolong QTc interval
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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
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
this is the standard malaria control interventions in the Gambia
|
Active Comparator: 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
|
this is the standard malaria control interventions in the Gambia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of malaria infection
Time Frame: at 12 months
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Prevalence of malaria infection determined by molecular methods number of participants with a positive varATS quantitative PCR divided by the total number of participants sampled
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at 12 months
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Vector's parous rate
Time Frame: 7-14 days after mass drug administration (MDA)
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Malaria prevalence will be used as an indicator of on-going malaria transmission, while vector's parous rate will quantify the effect of IVM on vector survival and mosquito population age structure.
Proportion: number of parous vectors divided by the total number of collected vectors
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7-14 days after mass drug administration (MDA)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
malaria prevalence
Time Frame: at 6 months
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malaria prevalence at the peak of the first transmission season of number of participants with a positive varATS quantitative PCR divided by the total number of participants sampled
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at 6 months
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incidence of clinical (laboratory confirmed) malaria cases
Time Frame: after MDA over 6 months period
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incidence of clinical (laboratory confirmed) malaria cases at health facilities of Number of clinical malaria cases observed divided by person-years of follow-up
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after MDA over 6 months period
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serological markers of recent malaria
Time Frame: after MDA over 6 months period
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serological markers of recent malaria infection by Mean Fluorescent Intensity of the different antigens will be determined and presented as a geometric mean
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after MDA over 6 months period
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serological markers of recent Anopheles exposure
Time Frame: after MDA over 6 months period
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serological markers of recent Anopheles exposure by Mean Fluorescent Intensity of the different antigens will be determined and presented as a geometric mean
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after MDA over 6 months period
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mosquito density
Time Frame: over 24 months after MDA
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Total number of mosquitoes collected during the study period across both intervention and control villages
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over 24 months after MDA
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mosquito mortality
Time Frame: 21 days post treatment
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mosquito mortality after feeding on IVM treated individuals Number of mosquitoes that die after a blood meal 21 days post-treatment divided by total number of mosquitoes blood fed
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21 days post treatment
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sporozoite rates in field-caught mosquitoes
Time Frame: over 24 months after MDA
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Number of P. falciparum circumsporozoite antibody (CSP) positive mosquitoes divided by the total number of mosquitoes caught
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over 24 months after MDA
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
drug resistance markers
Time Frame: after MDA 6 months
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prevalence of drug resistance markers in the number of malaria parasites with drug-resistance markers divided by the total number of samples tested
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after MDA 6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Umberto D'alessandro, MD, PhD, MRC @ LSHTM
Publications and helpful links
General Publications
- Dabira ED, Soumare HM, Conteh B, Ceesay F, Ndiath MO, Bradley J, Mohammed N, Kandeh B, Smit MR, Slater H, Peeters Grietens K, Broekhuizen H, Bousema T, Drakeley C, Lindsay SW, Achan J, D'Alessandro U. Mass drug administration of ivermectin and dihydroartemisinin-piperaquine against malaria in settings with high coverage of standard control interventions: a cluster-randomised controlled trial in The Gambia. Lancet Infect Dis. 2022 Apr;22(4):519-528. doi: 10.1016/S1473-3099(21)00557-0. Epub 2021 Dec 15.
- Dabira ED, Soumare HM, Lindsay SW, Conteh B, Ceesay F, Bradley J, Kositz C, Broekhuizen H, Kandeh B, Fehr AE, Nieto-Sanchez C, Ribera JM, Peeters Grietens K, Smit MR, Drakeley C, Bousema T, Achan J, D'Alessandro U. Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High Coverage of Malaria Control Interventions: Protocol for the MASSIV Cluster Randomized Clinical Trial. JMIR Res Protoc. 2020 Nov 19;9(11):e20904. doi: 10.2196/20904.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCC 1593
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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