Evidence map›Paper›PMID 36939832›Full record

ArticleJMIR research protocols2023

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.

Brian D Foy, Anthony Some, Tereza Magalhaes, Lyndsey Gray, Sangeeta Rao, Emmanuel Sougue, Conner L Jackson, John Kittelson, Hannah C Slater, Teun Bousema and 8 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03967054 (Repeat Ivermectin Mass Drug Administrations for MALaria Control II), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.3field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03967054 phase3completednot on this map

Repeat Ivermectin Mass Drug Administrations for MALaria Control II (RIMDAMAL II): a Double-blind, Cluster-randomized Control Trial for Integrated Control of Malaria

TypeinterventionalSponsorBrian FoyRan2019 to 2024Enrolled4,124ConditionsMalariaArmsIvermectin, Placebo oral tablet
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 4 countries.

Brian D FoyCenter for Vector-Borne Infectious Diseases, Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO, United States.ORCID https://orcid.org/0000-0002-9117-203X
Anthony SomeInstitut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.ORCID https://orcid.org/0000-0002-4625-7499
Tereza MagalhaesDepartment of Entomology, Texas A&M University, College Station, TX, United States.ORCID https://orcid.org/0000-0003-1474-0889
Lyndsey GrayCenter for Vector-Borne Infectious Diseases, Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO, United States.ORCID https://orcid.org/0000-0001-5897-464X
Sangeeta RaoDepartment of Clinical Sciences, Colorado State University, Fort Collins, CO, United States.ORCID https://orcid.org/0000-0002-9234-0082
Emmanuel SougueInstitut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.ORCID https://orcid.org/0000-0001-9974-0671
Conner L JacksonDepartment of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, United States.ORCID https://orcid.org/0000-0002-3519-5667
John KittelsonDepartment of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, United States.ORCID https://orcid.org/0000-0002-4929-1414
Hannah C SlaterMalaria and Neglected Tropical Diseases, Program for Appropriate Technology in Health, Seattle, WA, United States.ORCID https://orcid.org/0000-0003-4291-7899
Teun BousemaRadboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.ORCID https://orcid.org/0000-0003-2666-094X
Ollo DaInstitut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.ORCID https://orcid.org/0000-0002-6319-5322
A Gafar V CoulidiatyInstitut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.ORCID https://orcid.org/0000-0002-6050-8573
McKenzie ColtDepartment of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.ORCID https://orcid.org/0000-0002-7141-1179
Martina WadeDepartment of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.ORCID https://orcid.org/0000-0003-2898-1296
Kacey RichardsDepartment of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.ORCID https://orcid.org/0000-0002-5624-9791
A Fabrice SomeInstitut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.ORCID https://orcid.org/0000-0002-1530-1493
Roch K DabireInstitut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.ORCID https://orcid.org/0000-0002-3471-3506
Sunil ParikhDepartment of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.ORCID https://orcid.org/0000-0001-9411-5180
Institut de Recherche en Sciences de la Santé · BFYale University · USColorado State University · USColorado School of Public Health · USProgram for Appropriate Technology in Health · USRadboud University Nijmegen · NLUniversidade Federal da Bahia · BR

Funding

Repeat Ivermectin Mass Drug Administrations for MALaria control II (RIMDAMAL II): a double-blind cluster randomized trial for integrated control of malariaU01AI138910 · NIAID · COLORADO STATE UNIVERSITY · PI FOY, BRIAN DAVID, PARIKH, SUNIL · 2018 to 2022
$3.5M
NIAID NIH HHS U01 AI138910
6 · The paper itself

Abstract

backgroundThe gains made against malaria have stagnated since 2015, threatened further by increasing resistance to insecticides and antimalarials. Improvement in malaria control necessitates a multipronged strategy, which includes the development of novel tools. One such tool is mass drug administration (MDA) with endectocides, primarily ivermectin, which has shown promise in reducing malaria transmission through lethal and sublethal impacts on the mosquito vector.

objectiveThe primary objective of the study is to assess the impact of repeated ivermectin MDA on malaria incidence in children aged ≤10 years.

methodsRepeat Ivermectin MDA for Malaria Control II is a double-blind, placebo-controlled, cluster-randomized, and parallel-group trial conducted in a setting with intense seasonal malaria transmission in Southwest Burkina Faso. The study included 14 discrete villages: 7 (50%) randomized to receive standard measures (seasonal malaria chemoprevention [SMC] and bed net use for children aged 3 to 59 months) and placebo, and 7 (50%) randomized to receive standard measures and monthly ivermectin MDA at 300 μg/kg for 3 consecutive days, provided under supervision to all eligible village inhabitants, over 2 successive rainy seasons. Nonpregnant individuals >90 cm in height were eligible for ivermectin MDA, and cotreatment with ivermectin and SMC was not permitted. The primary outcome is malaria incidence in children aged ≤10 years, as assessed by active case surveillance. The secondary safety outcome of repeated ivermectin MDA was assessed through active and passive adverse event monitoring.

resultsThe trial intervention was conducted from July to November in 2019 and 2020, with additional sampling of humans and mosquitoes occurring through February 2022 to assess postintervention changes in transmission patterns. Additional human and entomological assessments were performed over the 2 years in a subset of households from 6 cross-sectional villages. A subset of individuals underwent additional sampling in 2020 to characterize ivermectin pharmacokinetics and pharmacodynamics. Analysis and unblinding will commence once the database has been completed, cleaned, and locked.

conclusionsOur trial represents the first study to directly assess the impact of a novel approach for malaria control, ivermectin MDA as a mosquitocidal agent, layered into existing standard-of-care interventions. The study was designed to leverage the current SMC deployment infrastructure and will provide evidence regarding the additional benefit of ivermectin MDA in reducing malaria incidence in children. TRIAL REGISTRATIONS: ClinicalTrials.gov NCT03967054; https://clinicaltrials.gov/ct2/show/NCT03967054 and Pan African Clinical Trials Registry PACT201907479787308; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=8219. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41197.

Indexed as

Anophelesclinical trialcluster-randomizedendectocideivermectinmalariamass drug administrationmosquitoseasonal malaria chemopreventiontransmission

Identifiers

PMID36939832
PMCPMC10132043
OpenAlexW4318710361

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.