Malaria Clinical Trial
— BOHEMIAOfficial title:
A Phase III Cluster-randomized, Open-label, Clinical Trial to Study the Safety and Efficacy of Ivermectin Mass Drug Administration to Reduce Malaria Transmission in Two African Settings
Verified date | February 2024 |
Source | Barcelona Institute for Global Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The BOHEMIA program consists of a combination of studies organized around a central community prevention mass drug administration protocol and four sub-studies (i.e.; social science, entomology, health economics, and environmental), each written as an individual protocol. The protocol is central but used in two separate, individually powered trials in Mozambique and Kenya. The trials have been powered on the efficacy outcome and designed to meet the requirements of WHO´s preferred product characteristics (PPC) for endectocides.
Status | Active, not recruiting |
Enrollment | 53000 |
Est. completion date | October 31, 2024 |
Est. primary completion date | April 16, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Week to 99 Years |
Eligibility | Inclusion Criteria: For human treatment/safety cohort - Residents of the study area - Male or female weighing more than 15kg - Adult able to provide written consent - Minors aged 12 to 17 able to provide assent - Parent/guardian's able to provide consent for minors - Negative pregnancy test for women aged between 13 and 49 - Agreement to adhere to study visits and procedures For pediatric active cohort: - Children in the age of highest burden at the time of enrollment (under 5 years of age in Mozambique or 5-15 in Kenya) - Residents of the study area - Parent/guardian's able to provide consent for minors - Minors aged 12 to 15 in Kenya able to provide assent For cross sectionals - Residents of the area for at least 3 months prior to enrolment - Parent/guardian's consent for minors - Ability to provide assent for minors aged 12 to 17 - Written consent from adults For livestock treatment: - Owner/guardian able to provide consent - Animal expected to spend at least one week every study month inside the cluster border Exclusion Criteria: 5.2.1. For human treatment/safety cohort: - Known hypersensitivity to ivermectin or albendazole - Risk of Loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria or Sudan - Pregnant women - Lactating women in the first week postpartum - Children < 15 kg - Currently participating in another clinical trial - Unwilling to provide informed consent or assent - Unwilling to adhere to study visits and/or procedures - Severely ill either self-reported or in the eyes of the investigator, e.g. defined as need for clinical care, or active or progressive disease interfering with activities of daily living. If in doubt, these criteria can be confirmed after a call with either the site PI/MD/safety officer against a pre-defined list. - Currently under treatment with inhibitors of CYP3A or P-gp or other drugs that can interfere with the study For incidence cohort: - Non-residents - Currently enrolled in other clinical trial For cross sectionals • Non-residents For livestock treatment - Received ivermectin three weeks than four weeks ago - Intention to milk or slaughter the animal for human consumption during the withdrawal period - Calves under 8 weeks and piglets under 6 weeks of age |
Country | Name | City | State |
---|---|---|---|
Kenya | KEMRI | Kwale | Pongwe-Kikoneni And Ramisi, Kwale |
Mozambique | CISM | Mopeia | Zambezia |
Lead Sponsor | Collaborator |
---|---|
Barcelona Institute for Global Health | UNITAID |
Kenya, Mozambique,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Using a rapid serologic test to determine the prevalence of COVID-19 antibodies in a sub-sample of the participant population in Mozambique | Use of rapid serologic tests to provide more accurate data on the sero-prevalence of COVID-19 in the district of Mopeia | 6 months | |
Other | Using a rapid serologic test to determine the incidence of COVID-19 antibodies in a sub-sample of the participant population in Mozambique | Use of rapid serologic tests to provide more accurate data on the sero-incidence of COVID-19 in the district of Mopeia | 6 months | |
Other | Using transcriptomic and antibody response patterns to assess whether ivermectin effects the immune response | Samples from a sub-sample of participants will be collected to assess the potential direct or indirect effect of ivermectin on the immune response to the malaria parasite | 6 months | |
Other | To assess whether self-reported Last Menstrual Period (LMP) can be used as a tool for determining conception. | To evaluate the correlation between self-reported pregnancy status, the LMP and the results of urine pregnancy tests in women of reproductive age participating in the study | 3 months | |
Other | Assess all-cause and malaria-related mortality in intervention and control arms | Using verbal autopies to assess all-cause and malaria-related mortality in intervention and control arms | 18 months | |
Other | To estimate the prevalence of relevant CYP and P-gp variations in the target population and subjects suffering from CNS-AEs | Samples will be collected from the first 100 participants reporting CNS AEs for pharmacogenetic testing for CYP 3A5 and ABCB1 SNPs | 3 months | |
Primary | To determine the safety (in humans) and efficacy of ivermectin MDA (administered to humans or humans and livestock simultaneously) for the prevention of malaria | Infection incidence across 6 months of follow up has been chosen as primary outcome based on the WHOs PPC for endectocides | 6 months | |
Secondary | Assess the efficacy of the intervention using number of hospitalisations | To assess whether ivermectin works as a complementary vector control tool, the number of hospitalisations occuring in the efficacy cohort group during the trial will be compared to previous years' data | 6 months | |
Secondary | Assess the safety of the intervention based on the number of related SAEs reported | To assess the safety of the intervention based on the number of related SAEs reported during the trial, including pregnancy outcomes | 12 months | |
Secondary | PK assays to support the BOHEMIA trial dosage and regimen | PK results from a sub-sample of the participant population are compared with actual or modelled parameters for the currently label-approved doses of ivermectin to determine optimal dosing and regimen | 72 hours | |
Secondary | Assess the impact of ivermectin MDA at the proposed regimen on the prevalence of selected ectoparasitic neglected tropical diseases (NTDs) | o assess the impact of ivermectin MDA at the proposed regimen on the prevalence of selected ectoparasitic neglected tropical diseases (NTDs) (scabies, headlice, tungiasis, and bed bugs) | 6 months | |
Secondary | Using RDT results to compare malaria incidence in children under 5 with community prevalence one month post last dose | To assess the relationship between malaria incidence in children under 5 and community prevalence one month post last dose using data from RDTs in the efficacy cohort (this serves for prevalence outcomes and paves the way for future studies using prevalence as outcome which is much less resource-consuming than incidence) | 6 months | |
Secondary | Using data from health facility malaria registers (passive surveillance) to compare with data from active case finding in the community by healthworkers to establish trends, relationships and patterns between the two. | Staff based in health facilities will capture malaria data from facility records which will be compared to data collected in the field to assess the relationship between active and passive surveillance for malaria at health facility (this serves as validation of passive surveillance and paves the way for future studies using passive surveillance as outcome which is much less resource-consuming than active surveillance, ensuring no key safety events are missed) | 18 months | |
Secondary | Assess the accuracy for malaria diagnosis of two different malaria rapid diagnostic tests | To assess the accuracy for malaria diagnosis of two different malaria rapid diagnostic tests (RDTs) used in comparison to polymerase chain reaction (PCR) (this is directly linked to efficacy as determined by RDTs) | 6 months |
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