Repeat Ivermectin Mass Drug Administrations for MALaria Control II
Condition: Malaria
MeSH terms: Malaria
Intervention: Ivermectin; Placebo oral tablet
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.; placebo in the same size, color and shape at the ivermectin tablet
Intervention MeSH terms: Ivermectin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
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.
Enrollment: 4124.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mosquito; ivermectin; Anopheles; Plasmodium

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.
    

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