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Repeat Ivermectin Mass Drug Administrations for MALaria Control II (RIMDAMAL II)

Primary Purpose

Malaria

Status

Active

Phase

Phase 3

Locations

Burkina Faso

Study Type

Interventional

Intervention

Ivermectin

Placebo oral tablet

About this trial

This is an interventional prevention trial for Malaria focused on measuring mosquito, ivermectin, Anopheles, Plasmodium

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (for being enrolled in the study):

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)
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

Sites / Locations

Institut de Recherche en Sciences de la Sante

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ivermectin mass drug administration

Placebo mass administration

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Malaria incidence

Incidence of malaria episodes in enrolled village children ≤ 10 years of age

Secondary Outcome Measures

Adverse Events

Number of participants with adverse events in the study population over the course of the intervention period

Blood fed mosquito mortality

Rate of blood fed mosquito mortality following capture

Full Information

NCT ID

NCT03967054

First Posted

May 24, 2019

Last Updated

September 23, 2022

Sponsor

Brian Foy

Collaborators

Yale University, Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest, Radboud University Medical Center, PATH

1. Study Identification

Unique Protocol Identification Number

NCT03967054

Brief Title

Repeat Ivermectin Mass Drug Administrations for MALaria Control II

Acronym

RIMDAMAL II

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 13, 2019 (Actual)

Primary Completion Date

November 8, 2020 (Actual)

Study Completion Date

August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Brian Foy

Collaborators

Yale University, Institut de Recherche en Sciences de la Sante-Direction Regionale de l'Ouest, Radboud University Medical Center, PATH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

mosquito, ivermectin, Anopheles, Plasmodium

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Parallel-assignment trial with two arms randomized in a 1:1 ratio.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The study pharmacist in charge of the drug stock room will originate the masking and maintain the masking from all other investigators. The masking codes will be written on three paper copies and put in identical and sealed opaque envelopes, which will be kept in three different areas.

Allocation

Randomized

Enrollment

4088 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ivermectin mass drug administration

Arm Type

Experimental

Arm Description

Arm Title

Placebo mass administration

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ivermectin

Other Intervention Name(s)

Iver P

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Intervention Description

placebo in the same size, color and shape at the ivermectin tablet

Primary Outcome Measure Information:

Title

Malaria incidence

Description

Incidence of malaria episodes in enrolled village children ≤ 10 years of age

Time Frame

up to 8 months

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Number of participants with adverse events in the study population over the course of the intervention period

Time Frame

up to 25 months

Title

Blood fed mosquito mortality

Description

Rate of blood fed mosquito mortality following capture

Time Frame

up to 8 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (for being enrolled in the study): 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) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian D. Foy, PhD

Organizational Affiliation

Colorado State University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sunil Parikh, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de Recherche en Sciences de la Sante

City

Diebougou

State/Province

Sud-Ouest

Country

Burkina Faso

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

Within 6 mos of publication of the primary outcomes of the study.

Learn more about this trial

Repeat Ivermectin Mass Drug Administrations for MALaria Control II

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