Trial · NCT03967054

Repeat Ivermectin Mass Drug Administrations for MALaria Control II

NCT03967054, Phase 3, Completed, Brian Foy; results first posted 2024-01-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Repeat Ivermectin Mass Drug Administrations for MALaria Control II. Trials, record NCT03967054. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03967054

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Repeat Ivermectin Mass Drug Administrations for MALaria Control II
NCT number: NCT03967054
Status: Completed
Phases: Phase 3
Enrollment: 4,124 participants, actual
Lead sponsor: Brian Foy
Conditions: Malaria
Interventions: Ivermectin, Placebo oral tablet
First posted: 2019-05-30
Last updated: 2025-04-10
Results first posted: 2024-01-11

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Malaria Incidence	up to 8 months	Incidence of malaria episodes in enrolled village children ≤ 10 years of age
Secondary	Adverse Events	up to 8 months	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.
Secondary	Survival Rate of Blood Fed Mosquitoes	up to 8 months	Number of Blood Fed Mosquitoes Alive For 3 Days After Capture

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Malaria Incidence	up to 8 months	The primary outcome measure comes only from malaria incidence measurements within a cohort of village children (1531). It is not a measure of malaria incidence from all enrolled participants from the study villages. The majority of participants (1133/1531) within the child cohort were evaluated in both years, meaning that they contributed a malaria case count for both year 1 and year 2.	Malaria cases per person-week	MEAN
SECONDARY	Adverse Events	up to 8 months		adverse events	NUMBER
SECONDARY	Survival Rate of Blood Fed Mosquitoes	up to 8 months	This analysis population is not human participants but mosquitoes captured from participants' homes. These are blood fed Anopheles gambiae s.l. mosquitoes captured indoors in participants' home 1 week following each mass drug administration.	mosquitoes	COUNT_OF_UNITS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Malaria Incidence	Ivermectin Mass Drug Administration	0.0176	95% Confidence Interval 0.0124 to 0.0252	Malaria cases per person-week
Malaria Incidence	Placebo Mass Administration	0.0183	95% Confidence Interval 0.0128 to 0.0262	Malaria cases per person-week
Adverse Events	Ivermectin Mass Drug Administration	438		adverse events
Adverse Events	Placebo Mass Administration	402		adverse events
Survival Rate of Blood Fed Mosquitoes	Ivermectin Mass Drug Administration	399		mosquitoes
Survival Rate of Blood Fed Mosquitoes	Placebo Mass Administration	896		mosquitoes

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	Ivermectin Mass Drug Administration	2,191	7
Overall Study	STARTED	Placebo Mass Administration	1,933	7
Overall Study	COMPLETED	Ivermectin Mass Drug Administration	2,191	7
Overall Study	COMPLETED	Placebo Mass Administration	1,933	7
Overall Study	NOT COMPLETED	Ivermectin Mass Drug Administration	0	0
Overall Study	NOT COMPLETED	Placebo Mass Administration	0	0

Source ClinicalTrials.gov

Adverse events102

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	malaria	Infections and infestations	Ivermectin Mass Drug Administration	355	2,191	466
other	malaria	Infections and infestations	Placebo Mass Administration	308	1,933	436
other	abdominal pain	Gastrointestinal disorders	Ivermectin Mass Drug Administration	1	2,191	1
other	abdominal pain	Gastrointestinal disorders	Placebo Mass Administration	2	1,933	2
other	abcess	Skin and subcutaneous tissue disorders	Ivermectin Mass Drug Administration	0	2,191	0
other	abcess	Skin and subcutaneous tissue disorders	Placebo Mass Administration	2	1,933	2
other	arthralgia	Musculoskeletal and connective tissue disorders	Ivermectin Mass Drug Administration	0	2,191	0
other	arthralgia	Musculoskeletal and connective tissue disorders	Placebo Mass Administration	6	1,933	6
other	bite wound	Injury, poisoning and procedural complications	Ivermectin Mass Drug Administration	0	2,191	0
other	bite wound	Injury, poisoning and procedural complications	Placebo Mass Administration	2	1,933	2

1 to 10 of 102Source ClinicalTrials.gov

See all 102 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ivermectin Mass Drug Administration	6	2,191
Total, all-cause mortality	Placebo Mass Administration	3	1,933
Total, other adverse events	Ivermectin Mass Drug Administration	430	2,191
Total, other adverse events	Placebo Mass Administration	396	1,933
Total, serious adverse events	Ivermectin Mass Drug Administration	8	2,191
Total, serious adverse events	Placebo Mass Administration	6	1,933

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36939832	DERIVED	PubMed
39919778	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01AI138910	Repeat Ivermectin Mass Drug Administrations for MALaria control II (RIMDAMAL II): a double-blind cluster randomized trial for integrated control of malaria	FOY, BRIAN DAVID; PARIKH, SUNIL	COLORADO STATE UNIVERSITY	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2018 to 2022

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ivermectin Mass Drug Administration vs Placebo Mass Administration: deaths from any cause	Trial comparisons
Ivermectin Mass Drug Administration vs Placebo Mass Administration: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03967054

GET https://conductscience.org/api/trials/v1/NCT03967054/events?page=2

API reference For AI assistants