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Trial record 8 of 106 for:    IVERMECTIN

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

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ClinicalTrials.gov Identifier: NCT03967054
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Yale University
Institut de Recherche en Sciences de la Sante
Radboud University
PATH
Information provided by (Responsible Party):
Brian Foy, Colorado State University

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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Ivermectin Drug: Placebo oral tablet Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel-assignment trial with two arms randomized in a 1:1 ratio.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Prevention
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
Actual Study Start Date : July 13, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Ivermectin mass drug administration
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.
Drug: Ivermectin
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.
Other Name: Iver P

Placebo Comparator: Placebo mass administration
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.
Drug: Placebo oral tablet
placebo in the same size, color and shape at the ivermectin tablet




Primary Outcome Measures :
  1. Malaria incidence [ Time Frame: up to 8 months ]
    Incidence of uncomplicated malaria episodes in enrolled village children ≤ 10 years of age


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: up to 25 months ]
    Number of participants with adverse events in the study population over the course of the intervention period

  2. Blood fed mosquito mortality [ Time Frame: up to 8 months ]
    Rate of blood fed mosquito mortality following capture

  3. Entomological inoculation rate [ Time Frame: Approximately 8 months over 2 consecutive rainy seasons (2019-2020) ]
    Rate of infectious mosquito bites per cross-section participant over time

  4. Human antibody responses to an Anopheles salivary gland peptide [ Time Frame: up to 8 months ]
    IgG antibody reactivity from cross-section participants to an Anopheles salivary gland peptide over each rainy season

  5. Plasmodium prevalence [ Time Frame: up to 8 months ]
    Proportion of cross-section participants with Plasmodium blood infections over time

  6. Plasmodium parasitemia [ Time Frame: up to 8 months ]
    Density of Plasmodium parasites in the blood of cross-section participants over time

  7. Plasmodium multiplicity of infection [ Time Frame: up to 8 months ]
    number of Plasmodium clones per infected blood sample from infected cross-section participants over time

  8. Plasmodium molecular force of infection [ Time Frame: up to 8 months ]
    number of new Plasmodium clones per cross-section participant over time



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967054


Contacts
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Contact: Catherine Bens 970-491-5445 Cat.Bens@colostate.edu
Contact: Tammy Felton-Noyle 970-491-1655 Tammy.Felton-Noyle@colostate.edu

Locations
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Burkina Faso
Institut de Recherche en Sciences de la Sante Recruiting
Diebougou, Sud-Ouest, Burkina Faso
Contact: Roch K Dabire, PhD    +226 70 73 90 69    dabireroch@gmail.com   
Contact: Fabrice A Some, PhD    +226 70 01 13 80    afabricesome@yahoo.fr   
Sponsors and Collaborators
Brian Foy
Yale University
Institut de Recherche en Sciences de la Sante
Radboud University
PATH
Investigators
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Principal Investigator: Brian D. Foy, PhD Colorado State University
Principal Investigator: Sunil Parikh, MD Yale University

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Responsible Party: Brian Foy, Professor, Colorado State University
ClinicalTrials.gov Identifier: NCT03967054     History of Changes
Other Study ID Numbers: 18-1803H
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Within 6 mos of publication of the primary outcomes of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Foy, Colorado State University:
mosquito
ivermectin
Anopheles
Plasmodium
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents