Trial · NCT02509481

Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study

NCT02509481, Phase 2, Phase 3, Completed, Colorado State University; results first posted 2019-01-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study. Trials, record NCT02509481. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02509481

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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 Control of Malaria: a Pilot Safety and Efficacy Study
NCT number: NCT02509481
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 2,712 participants, actual
Lead sponsor: Colorado State University
Conditions: Malaria, Lymphatic Filariasis
Interventions: Ivermectin, Albendazole
First posted: 2015-07-28
Last updated: 2019-01-04
Results first posted: 2019-01-04
Limitations and caveats: We could not provide placebo MDA for the control villages, and the trial was not blinded to the study population or the study team. Adverse event analysis bias may have from the knowledge of the village populace as to what arm they were part of.

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Incidence of Clinical Malaria Episodes	Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm	Cumulative incidence of malaria episodes in a cohort of village children ≤ 5 years of age (as assessed by active case surveillance in study villages - malaria episode defined as ≥38.0°C fever or history of fever in the last 24 hours + positive rapid diagnostic test for Plasmodium falciparum). Incidence is reported as malaria episodes per child over the course of the trial, a higher incidence is a worse outcome.
Secondary	Adverse Events	Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm	The number of adverse events. Adverse events data were collected via passive case detection from total population.
Secondary	Entomological Indicator of Parasite Transmission	Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm	Change in human IgG reactivity (optical density; ∆OD) to an Anopheles salivary gland antigen (peptide gSG6-P1) over the trial period. A score of 0 indicates no change in seroreactivity from from immediately before to immediately after the trial, suggesting consistent mosquito biting throughout the trial. A positive score indicates increasing seroreactivity and thus increasing mosquito biting on participants from immediately before to immediately after the trial. A negative score indicates decreasing seroreactivity and thus decreasing mosquito biting on participants from immediately before to immediately after the trial.
Secondary	Molecular Force of P. Falciparum Infection	Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm	Examination of new P. falciparum clones acquired from the beginning to the end of the intervention (molecular force of infection; mFOI) per child. Molecular genotyping used capillary blood taken at the time of diagnosis of each positive malaria episode and consisted of nPCR of the msp2 gene. We calculated the multiplicity of infection (MOI) per malaria episode, and then calculated the molecular force of infection (mFOI) associated with malaria episodes per child (over course of the trial)
Secondary	Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH)	Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm	Prevalence of soil transmitted helminth infections in children between 6-10 years old from the beginning to the end of the intervention
Secondary	Entomological Inoculation Rate	6 sampling periods over 18 weeks, starting in week 2 following the first MDA, and sampling every 3 weeks thereafter until week 17 of the treatment phase.	The entomological inoculation rate (EIR per week per person) is the measure of the human biting rate per person per week, multiplied by the sporozoite rate (in biting mosquitoes) per week, an estimated from sampling mosquitoes from 8 households located in the center of each study village. The EIR was calculated for each of the 6 sampling weeks of the treatment phase.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Clinical Malaria Episodes	Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm	Note that the primary outcome measure comes only from malaria incidence measurements within this child cohort (590 children). It is not a measure of malaria incidence from all enrolled participants from the study villages (2712 participants).	episodes	MEAN
SECONDARY	Adverse Events	Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm	Per protocol, the secondary outcome was a measure of all adverse events, excluding uncomplicated malaria episodes that were reported in the primary outcome, that occurred among the total enrolled population from the study villages (2712 participants).	adverse events	NUMBER
SECONDARY	Entomological Indicator of Parasite Transmission	Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm	We sampled finger capillary blood pre-intervention from a subset of enrolled participants located in 8 households at the center of each study village, and then re-sampled their blood immediately after the intervention period. Data were reported only from participants that gave both sets of samples (221 of 2712 participants).	change in IgG ELISA optical density	MEAN
SECONDARY	Molecular Force of P. Falciparum Infection	Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm	Molecular genotyping was performed on blood samples from 132 enrolled cohort children who were selected using a random sequence generator. Genotyping was successful on blood spots corresponding to 153 malaria episodes, which allowed us to calculate the mFOI over the trial from 76 enrolled children from the cohort.	new P. faliciparum infections per child	MEDIAN
SECONDARY	Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH)	Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm	This outcome was only measured in older enrolled children between 6-10 years of age, who were not in our primary outcome cohort, and who were eligible to be treated with ivermectin due to their height \>90 cm (232 of 2712 participants).	participants	NUMBER
SECONDARY	Entomological Inoculation Rate	6 sampling periods over 18 weeks, starting in week 2 following the first MDA, and sampling every 3 weeks thereafter until week 17 of the treatment phase.	The mean EIR was calculated across the 6 sampling periods in the 8 study villages (4 villages in each arm). EIR was calculated from the number of mosquitoes captured in select houses and the number of enrolled participants who lived in each sampled house (324/1265 in single MDA arm, and 271/1447 in repeated MDA arm).	infectious bites per person per week	MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Incidence of Clinical Malaria Episodes	Single MDA	2.49	95% Confidence Interval 2.28 to 2.73	episodes
Incidence of Clinical Malaria Episodes	Repeated MDA	2.00	95% Confidence Interval 1.82 to 2.20	episodes
Adverse Events	Single MDA	24		adverse events
Adverse Events	Repeated MDA	45		adverse events
Entomological Indicator of Parasite Transmission	Single MDA	-0.057	95% Confidence Interval -0.096 to -0.017	change in IgG ELISA optical density
Entomological Indicator of Parasite Transmission	Repeated MDA	-0.124	95% Confidence Interval -0.161 to -0.088	change in IgG ELISA optical density
Molecular Force of P. Falciparum Infection	Single MDA	4	Inter-Quartile Range 2 to 7	new P. faliciparum infections per child
Molecular Force of P. Falciparum Infection	Repeated MDA	3	Inter-Quartile Range 2 to 5	new P. faliciparum infections per child
Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH)	Single MDA	3		participants
Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH)	Repeated MDA	0		participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Single MDA	1,265
Overall Study	STARTED	Repeated MDA	1,447
Overall Study	COMPLETED	Single MDA	1,265
Overall Study	COMPLETED	Repeated MDA	1,447
Overall Study	NOT COMPLETED	Single MDA	0
Overall Study	NOT COMPLETED	Repeated MDA	0

Source ClinicalTrials.gov

Adverse events88

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	Single MDA	2	1,265	2
other	malaria	Infections and infestations	Repeated MDA	2	1,447	2
other	acute malnutrition	Infections and infestations	Single MDA	2	1,265	2
other	acute malnutrition	Infections and infestations	Repeated MDA	5	1,447	5
other	fever	Infections and infestations	Single MDA	1	1,265	1
other	fever	Infections and infestations	Repeated MDA	0	1,447	0
other	diarrhea	Infections and infestations	Single MDA	1	1,265	1
other	diarrhea	Infections and infestations	Repeated MDA	0	1,447	0
other	unspecified injury	Injury, poisoning and procedural complications	Single MDA	1	1,265	1
other	unspecified injury	Injury, poisoning and procedural complications	Repeated MDA	0	1,447	0

1 to 10 of 88Source ClinicalTrials.gov

See all 88 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Single MDA	5	1,265
Total, all-cause mortality	Repeated MDA	15	1,447
Total, other adverse events	Single MDA	14	1,265
Total, other adverse events	Repeated MDA	26	1,447
Total, serious adverse events	Single MDA	10	1,265
Total, serious adverse events	Repeated MDA	19	1,447

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30878222	DERIVED

Source PubMed

Grants0

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.

None in this release.

Trial comparisons3

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

Comparison	Source
Single MDA vs Repeated MDA: Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH)	Trial comparisons
Single MDA vs Repeated MDA: deaths from any cause	Trial comparisons
Single MDA vs Repeated MDA: 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/NCT02509481

GET https://conductscience.org/api/trials/v1/NCT02509481/events?page=2

API reference For AI assistants