MalariaPhase 3RIMDAMAL IINCT03967054
Repeat Ivermectin Mass Drug Administrations for MALaria Control II
A Phase 3 study testing Ivermectin in people with Malaria, run by Brian Foy at 1 site in Burkina Faso.
Trial summary
RIMDAMAL II is a double-blind, cluster randomized trial in Burkina Faso designed to test whether repeated ivermectin mass drug administrations, integrated into a monthly delivery platform with standard malaria control measures of seasonal malaria chemoprevention and insecticide-treated bed net distribution in the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,124 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 13 Jul 2019to 1 Aug 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residence in selected study village
- Able to understand the information and willing to give consent or assent (age 12-18) and parent/guardian consent if study participant age is < 18 years of age.
- Exclusion Criteria (for participating in the intervention [ivermectin or placebo MDA]):
- Residence outside of the study village
- Height < 90 cm (*note: if subject becomes ≥90cm over course the trial, this exclusion criteria will no longer be valid in subsequent MDA)
- Current treatment with SP+AQ as part of SMC (restricted to children 3-59 months old) (*note: if subject discontinuous SP+AQ treatment because they become older than 59 months over course the trial, this exclusion criteria will no longer be valid in subsequent MDA)
Show all 12Show fewer
- Permanent disability or serious medical illness that prevents or impedes study participation and/or comprehension
- Pregnancy (screened for in women of child-bearing age [ages 15-45] using a pregnancy urine rapid test [e.g. SD Bioline hCG] the week prior to each MDA)
- Breast feeding if infant is within 1 week of birth
- Known allergy to ivermectin
- Possibility of Loa loa infection as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, Democratic Republic of Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria, and Sudan.
- Enrolled in any other active clinical trials
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Institut de Recherche en Sciences de la Sante
Diébougou, Sud-Ouest Region
About this study
Official title: Repeat Ivermectin Mass Drug Administrations for MALaria Control II (RIMDAMAL II): a Double-blind, Cluster-randomized Control Trial for Integrated Control of Malaria
RIMDAMAL II is a double-blind, cluster randomized trial in Burkina Faso designed to test whether repeated ivermectin mass drug administrations, integrated into a monthly delivery platform with standard malaria control measures of seasonal malaria chemoprevention and insecticide-treated bed net distribution in the Sahel, will reduce childhood malaria incidence.
Read the detailed description
The RIMDAMAL II trial is designed to determine the efficacy of adding seasonal ivermectin mass drug administrations to the standard-policy malaria control measures in the Sahel (seasonal malaria chemoprevention in children, maximum long-lasting insecticidal net coverage, intermittent preventive treatment in pregnancy), for reducing the incidence of uncomplicated malaria episodes in enrolled village children (≤ 10 years of age) assessed by active case surveillance. The investigators will also examine the safety of the intervention, as well as entomological and parasitological endpoints. This is a double-blind, cluster randomized trial in that will occur in villages in southwestern Burkina Faso over two consecutive rainy seasons. For the intervention, mass administration of ivermectin or placebo will be given monthly over 4 months of each rainy season to the eligible village population, each as 3-day course of 300 µg/kg/day. These mass drug administrations will occur simultaneously with the distribution of seasonal malaria chemoprevention drugs on the same monthly schedule to eligible children aged 3-59 months.
- Conditions
- Malaria
- Being tested
- Ivermectin, Placebo oral tablet
- Keywords
- mosquito, ivermectin, Anopheles, Plasmodium
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Also called Iver P
Ivermectin (6 mg tablet) given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands.
Placebo oral tabletDrug
placebo in the same size, color and shape at the ivermectin tablet
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin mass drug administration | Experimental | Ivermectin given monthly from July-October (4 times) as a 3-day course of 300 µg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; >158 cm = 4 tablet/day for 3 days. Receives: Drug: Ivermectin |
| Placebo mass administration | Placebo comparator | Placebo given monthly from July-October (4 times) as a 3-day course to all eligible persons per exclusion/inclusion criteria. Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; >158 cm = 4 tablet/day for 3 days. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria Incidence
Incidence of malaria episodes in enrolled village children ≤ 10 years of age
Measured: up to 8 months
Secondary outcomes (2)
Adverse Events
Number adverse events among the study population over the course of the intervention period. Note, this number includes all malaria cases that were part of the primary outcome that occurred in the cohort of children that were actively assessed for malaria on a weekly basis during the intervention.
Measured: up to 8 months
Survival Rate of Blood Fed Mosquitoes
Number of Blood Fed Mosquitoes Alive For 3 Days After Capture
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start13 Jul 2019
- Primary completion8 Nov 2020
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-assignment trial with two arms randomized in a 1:1 ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian Foy
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest, Radboud University Medical Center, PATH, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor-investigator, Brian Foy, Colorado State University
- Investigators
- Brian D. Foy, PhD, Principal investigator, Colorado State UniversitySunil Parikh, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967054
- Sponsor's protocol ID
- 1691
- Other IDs
- U01AI138910
- Acronym
- RIMDAMAL II
- Status last verified
- Apr 2025
- First submitted
- 24 May 2019
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected from this study, including de-identified individual participant data, will be made available upon publication to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. The finalized study protocol, statistical analysis plan, and informed consent forms will be made available on ClinicalTrials.gov.
Publications
Some AF, Some A, Sougue E, Ouedraogo COW, Da O, Dah SR, Nikiema F, Magalhaes T, Gray LI, Finical W, Pugh G, Lado P, Randall JC, Burton TA, Ring ME, Leon AS, Colt M, Li F, Wang K, Wade M, Lier AJ, Richards K, Sproch H, Zhang E, Ellman J, Achebe I, Jackson CL, Xiao M, Wu EJ, Bousema T, Slater HC, Foy BD, Parikh S, Dabire RK. Safety and efficacy of repeat ivermectin mass drug administrations for malaria control (RIMDAMAL II): a phase 3, double-blind, placebo-controlled, cluster-randomised, parallel-group trial. Lancet Infect Dis. 2025 Jul;25(7):737-750. doi: 10.1016/S1473-3099(24)00751-5. Epub 2025 Feb 4.
PubMed 39919778Foy BD, Some A, Magalhaes T, Gray L, Rao S, Sougue E, Jackson CL, Kittelson J, Slater HC, Bousema T, Da O, Coulidiaty AGV, Colt M, Wade M, Richards K, Some AF, Dabire RK, Parikh S. Repeat Ivermectin Mass Drug Administrations for Malaria Control II: Protocol for a Double-blind, Cluster-Randomized, Placebo-Controlled Trial for the Integrated Control of Malaria. JMIR Res Protoc. 2023 Mar 20;12:e41197. doi: 10.2196/41197.
PubMed 36939832
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeat Ivermectin Mass Drug Administrations for MALaria Control II (RIMDAMAL II): a Double-blind, Cluster-randomized Control Trial for Integrated Control of Malaria
- ClinicalTrials.gov ID
- NCT03967054
- Acronym / sponsor ID
- RIMDAMAL II / 1691
- Conditions
- Malaria
- Keywords
- mosquito, ivermectin, Anopheles, Plasmodium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,124 participants (actual)
- Lead sponsor
- Brian FoyUniversity, hospital or other
- Collaborators
- Yale University, Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest, Radboud University Medical Center, PATH, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 13 Jul 2019 (actual)
- Primary completion
- 8 Nov 2020 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Posted 11 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RIMDAMAL II is a double-blind, cluster randomized trial in Burkina Faso designed to test whether repeated ivermectin mass drug administrations, integrated into a monthly delivery platform with standard malaria control measures of seasonal malaria chemoprevention and insecticide-treated bed net distribution in the Sahel, will reduce childhood malaria incidence.
Detailed description
The RIMDAMAL II trial is designed to determine the efficacy of adding seasonal ivermectin mass drug administrations to the standard-policy malaria control measures in the Sahel (seasonal malaria chemoprevention in children, maximum long-lasting insecticidal net coverage, intermittent preventive treatment in pregnancy), for reducing the incidence of uncomplicated malaria episodes in enrolled village children (≤ 10 years of age) assessed by active case surveillance. The investigators will also examine the safety of the intervention, as well as entomological and parasitological endpoints. This is a double-blind, cluster randomized trial in that will occur in villages in southwestern Burkina Faso over two consecutive rainy seasons. For the intervention, mass administration of ivermectin or placebo will be given monthly over 4 months of each rainy season to the eligible village population, each as 3-day course of 300 µg/kg/day. These mass drug administrations will occur simultaneously with the distribution of seasonal malaria chemoprevention drugs on the same monthly schedule to eligible children aged 3-59 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-assignment trial with two arms randomized in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Ivermectin mass drug administration | Experimental | Drug: IvermectinIvermectin given monthly from July-October (4 times) as a 3-day course of 300 µg/kg/day to all eligible persons per exclusion/inclusion criteria. Per package insert, dosing of IVM will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; >158 cm = 4 tablet/day for 3 days. |
| Placebo mass administration | Placebo comparator | Drug: Placebo oral tabletPlacebo given monthly from July-October (4 times) as a 3-day course to all eligible persons per exclusion/inclusion criteria. Dosing of placebo will be according to height to approximate weight: 90-119 cm = 1 tablet/day for 3 days; 120-140 cm = 2 tablets/day for 3 days; 141-158 cm = 3 tablets/day for 3 days; >158 cm = 4 tablet/day for 3 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Residence in selected study village
- Able to understand the information and willing to give consent or assent (age 12-18) and parent/guardian consent if study participant age is < 18 years of age.
- Residence outside of the study village
- Height < 90 cm (*note: if subject becomes ≥90cm over course the trial, this exclusion criteria will no longer be valid in subsequent MDA)
- Current treatment with SP+AQ as part of SMC (restricted to children 3-59 months old) (*note: if subject discontinuous SP+AQ treatment because they become older than 59 months over course the trial, this exclusion criteria will no longer be valid in subsequent MDA)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvermectinAlso: Iver PIvermectin (6 mg tablet) given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands. | Drug | Ivermectin mass drug administration |
| Placebo oral tabletplacebo in the same size, color and shape at the ivermectin tablet | Drug | Placebo mass administration |
Primary outcome
Malaria Incidence
Time frame: up to 8 months
Incidence of malaria episodes in enrolled village children ≤ 10 years of age
2 secondary outcomes
Adverse Events
Time frame: up to 8 months
Survival Rate of Blood Fed Mosquitoes
Time frame: up to 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39919778Some AF, Some A, Sougue E, Ouedraogo COW, Da O, Dah SR, Nikiema F, Magalhaes T, Gray LI, Finical W, Pugh G, Lado P, Randall JC, Burton TA, Ring ME, Leon AS, Colt M, Li F, Wang K, Wade M, Lier AJ, Richards K, Sproch H, Zhang E, Ellman J, Achebe I, Jackson CL, Xiao M, Wu EJ, Bousema T, Slater HC, Foy BD, Parikh S, Dabire RK. Safety and efficacy of repeat ivermectin mass drug administrations for malaria control (RIMDAMAL II): a phase 3, double-blind, placebo-controlled, cluster-randomised, parallel-group trial. Lancet Infect Dis. 2025 Jul;25(7):737-750. doi: 10.1016/S1473-3099(24)00751-5. Epub 2025 Feb 4.
- Derived from this study: PubMed 36939832Foy BD, Some A, Magalhaes T, Gray L, Rao S, Sougue E, Jackson CL, Kittelson J, Slater HC, Bousema T, Da O, Coulidiaty AGV, Colt M, Wade M, Richards K, Some AF, Dabire RK, Parikh S. Repeat Ivermectin Mass Drug Administrations for Malaria Control II: Protocol for a Double-blind, Cluster-Randomized, Placebo-Controlled Trial for the Integrated Control of Malaria. JMIR Res Protoc. 2023 Mar 20;12:e41197. doi: 10.2196/41197.
- Individual participant dataSharing planned: Yes. Data collected from this study, including de-identified individual participant data, will be made available upon publication to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. The finalized study protocol, statistical analysis plan, and informed consent forms will be made available on ClinicalTrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian D. Foy, PhD principal investigator
Colorado State University
Sunil Parikh, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin in people with Malaria, run by Brian Foy at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malaria Incidence (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03967054, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.