A Phase 2/3 interventional study of Ivermectin and Albendazole in Malaria and Lymphatic Filariasis, sponsored by Colorado State University. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by Colorado State University · Phase 2/3, Interventional, and Treatment
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Among 10 studies testing ivermectin in Malaria — 1 open to participants now, 1 under way, 1 of them phase 3. Ivermectin · Malaria.
Among the 10 studies testing ivermectin in Malaria, this one is the 7th largest by enrollment, is one of 2 that started in 2015, is the only one in phase 2/3, and was the 2nd registered.
1,185 studies on the registry are indexed under Malaria; 80 are open to participants now.
Browse Malaria studies →1 of the 10 studies testing ivermectin in Malaria is open now, in 1 country. Recruiting first, the newest first:
Malaria Consortium · Sites in Burkina Faso
Ages 5–15
By country, each count listing its studies:
Ivermectin: first FDA approval 1996 (STROMECTOL). What it is approved for, and how studies give it, is on its page →
Of the 52 Malaria studies recruiting now, 15 (29%) set no upper age limit and 34 (65%) stop at 75 or younger; 38 take children under 18; 32 take healthy volunteers.
This study: all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 7 · Phase 4 1
First in 2015; this study’s year is marked. 2 started in 2015.
This study's enrollment of 2,712 is above the median of 252 across 938 interventional studies indexed under Malaria.
Median enrollment 4,532 across the 10 interventional studies. Of the 7 that completed or were terminated, 2 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 10 has an industry lead sponsor. The 9 most frequent:
Colorado State University is the lead sponsor of 118 studies on the registry; 20 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Colorado State University has 1 study filed under Malaria — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing ivermectin in Malaria, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to determine whether repeated ivermectin mass drug administrations to Burkinabé villagers, performed in three week intervals over the rainy-season, is well-tolerated and safe, and also effective in reducing local malaria transmission and thus clinical malaria episodes in treated village children.
Primary Objective: To determine the efficacy of repeated ivermectin mass drug administrations (IVM MDA) (150 µg/kg), given to the population of eligible patients in enrolled villages, for reducing the cumulative incidence of uncomplicated malaria episodes in enrolled village children (≤ 5 years of age) over the course of the treatment.
Hypothesis: Repeated IVM MDA starting at the beginning of the rainy season will be well tolerated and safe, and will reduce clinical malaria episodes in children by significantly reducing malaria transmission among treated villages.
Overview Study Design: Single-blind (outcomes assessor); parallel assignment with 2 arms; cluster-randomized control trial to determine the effect of repeated IVM MDA on malaria transmission and clinical malaria episodes. The unit of randomization will be the village (cluster). 8 villages total will be enrolled in two arms. The active comparator arm (4 villages) will receive a single standard MDA (IVM; 150-200 µg/kg + albendazole; 400 mg) soon after the start of the rainy season, while the experimental arm (4 villages) will receive the standard MDA on the same date, plus 5 more IVM MDA at 3 week intervals thereafter. The primary endpoint will be the cumulative incidence of clinical malaria episodes in children ≤5 year of age within each village.
Sites: This study will be conducted in villages along the main east-west and north-south road corridors in the Sud-Ouest administrative region of Burkina Faso.
Study Population: Indigenous Burkinabé from various ethnic groups (Dagara, Bobo, Lobi, Mossi, etc.). The entire eligible population of each enrolled village will receive the MDAs, following the standard inclusion/exclusion criteria of MDA for control of microfilaremia caused by Wuchereria bancrofti (lymphatic filariasis; LF). Clinical incidence of malaria will be assessed only in children living in enrolled villages who are ≤ 5 years of age, most of whom will not have received any treatment due to the standard MDA exclusion criteria of children \< 90 cm.
Study Interventions: 2 arms: 1) Active comparator arm - single standard MDA with IVM (150 µg/kg) + albendazole (ALB;400 mg) soon after the beginning of the rainy season; 2) Experimental arm, single standard MDA with IVM (150 µg/kg) + ALB (400 mg) plus 5 more MDA with IVM alone (150 µg/kg) at 3 week intervals thereafter. Community health workers and trained by local health authority of the Sud-Ouest region will perform the first MDA in both arms with logistical assistance from the study investigators. Repeated MDAs will only occur in the experimental-arm villages, and be performed by the study investigators.
Follow-up Procedures: Trained nurses will visit each study village each week over the course of the study to investigate and record any adverse events or severe adverse events communicated by the study population. They will also perform active case surveillance each week on enrolled village children for clinical malaria episodes, defined as ≥38.0°C fever or history of fever in the last 24 hours + positive rapid diagnostic test for Plasmodium falciparum. Secondary measures will be collected by the nurses.
Sample Size: Assuming an 80% cumulative incidence of malaria episodes in the control arm and an intracluster correlation coefficient of 0.02, 4 clusters are needed per arm and 69 children enrolled per cluster to detect a conservative 40% reduction in incidence in the treatment arm with 80% power and a statistical confidence of 95%.
Safety Outcomes:
Secondary Outcomes:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis.
Drug: Ivermectin · Drug: Albendazole
Same at Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter.
Drug: Ivermectin · Drug: Albendazole
Also known as: Mectizan
Incidence of Clinical Malaria Episodes
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.
Time frame: Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm
Adverse Events
The number of adverse events. Adverse events data were collected via passive case detection from total population.
Time frame: Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm
Entomological Indicator of Parasite Transmission
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.
Time frame: Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm
Molecular Force of P. Falciparum Infection
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)
Time frame: Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm
Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH)
Prevalence of soil transmitted helminth infections in children between 6-10 years old from the beginning to the end of the intervention
Time frame: Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm
Entomological Inoculation Rate
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.
Time frame: 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.
2712 participants from 8 villages were recruited to participate and enrolled. Importantly, the intervention (repeated ivermectin MDA) was given to most villagers and the safety outcome was assessed in this whole group. However, the primary outcome was assessed in a cohort of 590 enrolled village children ≤5 years old.
| Milestone | Single MDA | Repeated MDA |
|---|---|---|
| Started | 1265 | 1447 |
| Completed | 1265 | 1447 |
| Not completed | 0 | 0 |
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.
| episodes | Single MDA | Repeated MDA |
|---|---|---|
| Incidence of Clinical Malaria Episodes | 2.49 (2.28 to 2.73) | 2.00 (1.82 to 2.20) |
The number of adverse events. Adverse events data were collected via passive case detection from total population.
| adverse events | Single MDA | Repeated MDA |
|---|---|---|
| Adverse Events | 24 | 45 |
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.
| change in IgG ELISA optical density | Single MDA | Repeated MDA |
|---|---|---|
| Entomological Indicator of Parasite Transmission | -0.057 (-0.096 to -0.017) | -0.124 (-0.161 to -0.088) |
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)
| new P. faliciparum infections per child | Single MDA | Repeated MDA |
|---|---|---|
| Molecular Force of P. Falciparum Infection | 4 (2 to 7) | 3 (2 to 5) |
Prevalence of soil transmitted helminth infections in children between 6-10 years old from the beginning to the end of the intervention
| participants | Single MDA | Repeated MDA |
|---|---|---|
| Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH) | 3 | 0 |
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.
| infectious bites per person per week | Single MDA | Repeated MDA |
|---|---|---|
| Entomological Inoculation Rate | 0.2069 ± 0.2376 | 0.1972 ± 0.2084 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single MDA | 5/1,265 (0.4%) | 10/1,265 (0.8%) | 14/1,265 (1.1%) |
| Repeated MDA | 15/1,447 (1%) | 19/1,447 (1.3%) | 26/1,447 (1.8%) |
| Event | Single MDA | Repeated MDA |
|---|---|---|
| moderate to severe malariaInfections and infestations | 7/1265 | 7/1447 |
| neonatal infectionInfections and infestations | 1/1265 | 0/1447 |
| untreated decompensated hypertensive heart failureCardiac disorders | 1/1265 | 0/1447 |
| fever, vomiting, anorexiaInfections and infestations | 1/1265 | 0/1447 |
| Infectious pneumopathyRespiratory, thoracic and mediastinal disorders | 1/1265 | 0/1447 |
| acute intestinal obstructionGastrointestinal disorders | 0/1265 | 1/1447 |
| liver disease: ascites + bulky edema of the lower limbs.Hepatobiliary disorders | 0/1265 | 1/1447 |
| liver cancer, cirrhosis of the liverHepatobiliary disorders | 0/1265 | 1/1447 |
| abdominal pain, loose stool, vomitingGastrointestinal disorders | 0/1265 | 1/1447 |
| dyspneaRespiratory, thoracic and mediastinal disorders | 0/1265 | 1/1447 |
| Event | Single MDA | Repeated MDA |
|---|---|---|
| acute malnutritionInfections and infestations | 2/1265 | 5/1447 |
| vomitingGastrointestinal disorders | 0/1265 | 3/1447 |
| malariaInfections and infestations | 2/1265 | 2/1447 |
| pruritisImmune system disorders | 1/1265 | 2/1447 |
| feverInfections and infestations | 1/1265 | 0/1447 |
| diarrheaInfections and infestations | 1/1265 | 0/1447 |
| unspecified injuryInjury, poisoning and procedural complications | 1/1265 | 0/1447 |
| stage 3 tooth decay with local tumefactionInfections and infestations | 1/1265 | 0/1447 |
| Bilateral palpebral edemaEye disorders | 1/1265 | 0/1447 |
| Tremor, palpitations, arthralgiaGeneral disorders | 1/1265 | 0/1447 |
The total number of enrolled participants were most of population of the eight enrolled villages (2712 participants).
| Age, Continuous(years) | Single MDA | Repeated MDA | Total |
|---|---|---|---|
| Median | 14 (7 to 30) | 16 (6 to 35) | 15 (6 to 34) |
| Sex: Female, Male(Participants) | Single MDA | Repeated MDA | Total |
|---|---|---|---|
| Female | 620 | 713 | 1333 |
| Male | 645 | 734 | 1379 |
| Race (NIH/OMB)(Participants) | Single MDA | Repeated MDA | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1265 | 1447 | 2712 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Single MDA | Repeated MDA | Total |
|---|---|---|---|
| Burkina Faso | 1265 | 1447 | 2712 |
| Height <90 cm(Participants) | Single MDA | Repeated MDA | Total |
|---|---|---|---|
| Count of participants | 210 | 267 | 477 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Jun 2015, a primary completion of Nov 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2019, 3 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ivermectin