Adjunctive Ivermectin Mass Drug Administration for Malaria Control
MATAMAL
1 other identifier
interventional
24,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2021
CompletedFirst Posted
Study publicly available on registry
April 14, 2021
CompletedStudy Start
First participant enrolled
May 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedFebruary 24, 2022
February 1, 2022
1.8 years
March 17, 2021
February 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of infection with Plasmodium falciparum
Prevalence of infection with Plasmodium falciparum in all age groups estimated using a cross-sectional survey sample conducted during peak transmission season after 2 years of intervention
2 years
Secondary Outcomes (12)
Vector parous rate
7-14 days post-MDA
Prevalence of infection with Plasmodium falciparum
1 year
Incidence of clinical malaria (Passive Case Detection)
For six months during the malaria transmission season
Incidence of clinical malaria (Active Case Detection)
For six months during the malaria transmission season
Age-adjusted prevalence of recent exposure to Plasmodium falciparum
Peak transmission season at 1 year and 2 years
- +7 more secondary outcomes
Study Arms (2)
Ivermectin Mass Drug Administration
EXPERIMENTALIvermectin and Dihydroartemisinin-piperaquine MDA will be given to all eligible participants in each cluster (island) in addition to the standard national malaria control programme interventions.
Placebo Mass Drug Administration
PLACEBO COMPARATORPlacebo and Dihydroartemisinin-piperaquine MDA will be given to all eligible participants in each cluster (island) in addition to the standard national malaria control programme interventions.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Age over six months to receive dihydroartemisinin-piperaquine
- Height over 90cm or weight over 15kg to receive ivermectin or placebo
- Willingness to adhere to trial procedures
- Individual written, informed consent from the participant or parent/guardian in the case of participants below the age of 18 years (and assent in young people between the ages of 12 and 17 years of age)
You may not qualify if:
- Known severe chronic illness (AIDS, Tuberculosis, chronic malnutrition)
- Known hypersensitivity to either dihydroartemisinin-piperaquine or ivermectin
- Pregnancy (any trimester) and breastfeeding (for ivermectin (or placebo)) and pregnancy (first trimester only) (for dihydroartemisinin-piperaquine)
- Travel to a Loa loa endemic country (eg Central African Republic) (for ivermectin (or placebo))
- Concomitant drugs that influence cardiac function or affect the corrected QT interval (for dihydroartemisinin-piperaquine)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- Medical Research Council Unit, The Gambiacollaborator
- Ministerio de Saude Publica, Guinee-Bissaucollaborator
- Bandim Health Projectcollaborator
- Instituto Nacional de Estudos e Pesquisas, Guinee-Bissaucollaborator
Study Sites (1)
Bijagos Archipelago (islands)
Bissau, Guinea-Bissau
Related Publications (2)
Hutchins H, Pretorius E, Bradley J, Teixeira da Silva E, Vasileva H, Ndiath MO, Jones RT, Soumare HDM, Nyang H, Prom A, Sambou S, Ceesay F, Ceesay S, Moss S, Mabey D, Djata P, Nante JE, Martins C, Logan JG, Slater H, Tetteh K, Drakeley C, D'Alessandro U, Rodrigues A, Last A. Adjunctive ivermectin mass drug administration for malaria control on the Bijagos Archipelago of Guinea-Bissau (MATAMAL): a quadruple-blinded, cluster-randomised, placebo-controlled trial. Lancet Infect Dis. 2025 Apr;25(4):424-434. doi: 10.1016/S1473-3099(24)00580-2. Epub 2024 Nov 14.
PMID: 39551062DERIVEDHutchins H, Bradley J, Pretorius E, Teixeira da Silva E, Vasileva H, Jones RT, Ndiath MO, Dit Massire Soumare H, Mabey D, Nante EJ, Martins C, Logan JG, Slater H, Drakeley C, D'Alessandro U, Rodrigues A, Last AR. Protocol for a cluster randomised placebo-controlled trial of adjunctive ivermectin mass drug administration for malaria control on the Bijagos Archipelago of Guinea-Bissau: the MATAMAL trial. BMJ Open. 2023 Jul 7;13(7):e072347. doi: 10.1136/bmjopen-2023-072347.
PMID: 37419638DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna R Last, MBChB PhD
London School of Hygiene and Tropical Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- An independent statistician will randomize the clusters to DP+IVM or DP+Placebo. The Placebo is identical in size, shape and colour and packaging. An independent pharmacist at Medical Research Council Unit The Gambia @ London School of Hygiene and Tropical Medicine will label the IVM and Placebo according to the statistician's designation and maintain the masking from all other investigators. Specifically generated masking codes will be generated and saved in three separate encrypted locations securely. Only the statistician and the pharmacist will have access to the encryption key.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2021
First Posted
April 14, 2021
Study Start
May 3, 2021
Primary Completion
March 1, 2023
Study Completion
August 1, 2023
Last Updated
February 24, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The study protocol and Statistical Analysis Plan (SAP) will be made available on acceptance of the manuscript for publication. Participant information and Informed Consent Form (ICF) will be made available from recruitment. Results (including Clinical Study Report (CSR)) will be made available within six months of completion of the trial.
- Access Criteria
- Study Protocol and Statistical Analysis Plan (SAP) will be published in an Open Access peer-reviewed journal. The participant information and and informed consent form may be requested from the trial research team. Results and a clinical study report will be made available within six months of completion of the trial. Analytic code will be made available under a Creative Commons license. Publication of results will be Open-Access and available in pre-print on MedRxiv (The Preprint Server for Health Sciences).
There is a manuscript in preparation detailing the study protocol and statistical analysis plan. The participant information and and informed consent form may be requested from the trial research team. Results and a clinical study report will be made available within six months of completion of the trial. Analytic code will be made available under a Creative Commons license. Publication of results will be open-access and available in pre-print on MedRxiv (The Preprint Server for Health Sciences).