Malaria Clinical Trial
Official title:
Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study
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:
• Adverse events (seriousness, causality, expectedness)
Secondary Outcomes:
- Incidence of new P. falciparum infections acquired (molecular force-of-infection)
- Prevalence and intensity (eggs/larvae per gram of feces) of soil transmitted helminth
infections in a subset of treated patients between 6-10 years of age.
- Indoor-resting Anopheles mosquito capture rate
- Outdoor-host seeking Anopheles mosquito capture rate
- Adult mosquito age structure (parity rate) in captured mosquitoes
- Plasmodium sporozoite rate/entomological inoculation rate in captured mosquitoes
- Rate of Wuchereria bancrofti in captured mosquitoes
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04601714 -
Baseline Cohort Malaria Morbidity Study
|
||
Withdrawn |
NCT04020653 -
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
|
Phase 2 | |
Terminated |
NCT04368910 -
Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
|
Phase 3 | |
Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
Completed |
NCT02544048 -
Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
|
||
Completed |
NCT00527163 -
Role of Nitric Oxide in Malaria
|
||
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Active, not recruiting |
NCT04704674 -
Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
|
||
Completed |
NCT03276962 -
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
|
Phase 2 | |
Completed |
NCT04966871 -
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
|
Phase 1 | |
Completed |
NCT00289185 -
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
|
Phase 2 | |
Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
Active, not recruiting |
NCT06153862 -
Africa Ready Malaria Screening
|
N/A | |
Completed |
NCT04545905 -
Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
|
||
Recruiting |
NCT06278181 -
Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
|
||
Completed |
NCT02793622 -
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
|
Phase 3 | |
Withdrawn |
NCT02793414 -
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
|
||
Withdrawn |
NCT02793388 -
A Trial on Supervised Primaquine Use in Ethiopia
|
Phase 4 | |
Completed |
NCT02909712 -
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
|
Phase 2 | |
Completed |
NCT02536222 -
Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts
|
Phase 4 |