MalariaPhase 3BOHEMIANCT04966702
Broad One Health Endectocide-based Malaria Intervention in Africa (BOHEMIA)
A Phase 3 study testing Albendazole Pill, Ivermectin Pill and Ivermectin Injectable Product in people with Malaria, run by Barcelona Institute for Global Health at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 week to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Albendazole Pill, Ivermectin Pill and Ivermectin Injectable Product
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48,145 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Mar 2022to 3 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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 (Mozambique):
- Received ivermectin less than four weeks ago
- Intention to milk or slaughter the animal for human consumption during the withdrawal period (28 days after dosing)
- Calves under 8 weeks and piglets under 6 weeks of age
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official 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
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 World Health Organization's (WHO) preferred product characteristics (PPC) for endectocides.
Read the detailed description
WHO's PPC states that the desired efficacy of an endectocide as stand-alone insecticide in areas of high to moderate transmission is at least 20% reduction in the incidence of clinical malaria (as primary outcome) and incidence of infection (as secondary outcome) in children under 5 years old (the highest incidence age-group in areas with high-transmission), lasting for at least 1 month following a single regimen. Assessing this effect requires a cluster-randomized design with meticulous follow-up of a cohort of children for efficacy and the whole exposed population for safety outcomes, which is the design selected for the BOHEMIA trials.
Two BOHEMIA cluster randomized trials will be carried out in Mozambique (Southern Africa) and Kenya (Eastern Africa). These sites encompass different transmission dynamics that increase the generalizability of results, namely: (a) a gradient of malaria transmission: moderate in Kenya and very high in Mozambique, (b) different species composition of vector population, (c) different rain patterns and environmental conditions, and (d) different livestock species and human/livestock ratios (in Mozambique).
Population:
Co-primary objectives are determined in different populations. Efficacy is primarily determined in a pediatric active cohort (children under 5 years of age in Mozambique and 5-15 years in Kenya), and safety is determined in anyone who receives the drug. Pregnant women and children under 15 kgs are not eligible for treatment.
Treatment Groups:
Two groups of clusters (three in Mozambique) will be randomized to receive (a) ivermectin in humans, (b) ivermectin in humans + livestock (only in Mozambique), or (c) albendazole control. In Mozambique, the study district will be subject to enhanced passive surveillance for malaria.
Primary Outcome Measure:
The primary outcome measure is proposed as incidence in a six-month period given that ivermectin is a short-acting intervention with <1% residual drug at 30 days after each dose. Efficacy assessment will continue 4 months post last dose of ivermectin, and this will include analysis of the vector population. We have proposed the appropriate duration of impact evaluation relevant to the biology of the intervention, and geared towards being able to clean the data, lock the database, and conduct the primary efficacy and safety analysis efficiently.
Estimated Duration of Study:
Throughout the study there will be two different groups of participants enrolled, the ones receiving the treatment (>15 kg) and the ones in the active pediatric cohort for the main outcome of malaria incidence (the ages of highest incidence in each country, under 5 years of age in Mozambique and 5-15 years in Kenya). Each group will participate for different periods of time.
Only the group enrolled in the active pediatric cohort will contribute to the primary efficacy outcome and this group will participate from date of first dose for six months. The group receiving treatment (>15 kg) will contribute to the primary safety outcome and several secondary outcomes (PK, Neglected Tropical Diseases [NTDs]) and this group will participate for four months. Women of child-bearing age will be visited one month after the third dose for a final pregnancy test, any pregnancy occurring during the trial will be followed until birth. The cross-sectional survey will enroll participants of all ages one month after the last Mass Drug Administration (MDA) round.
WHO guidance states that trial design and duration should reflect the nature of the intervention and are left at the discretion of researchers. These trials are robustly powered and are being conducted in moderate to high burden areas, so we believe the risk of failing to find an effect is low and if so, it would throw the utility of the intervention into question.
Advancing the development of this new tool towards implementation in the field can be accomplished in a time frame to contribute to the 2030 Global Technical Strategy (GTS) goals.
- Conditions
- Malaria
- Being tested
- Albendazole Pill, Ivermectin Pill, Ivermectin Injectable Product
- Keywords
- ivermectin, malaria, vector control
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole PillDrug
Also called Alben, Bendex
Using a MDA approach, fieldworkers will administer albendazole using directly observed treatment methodology to participants
Ivermectin PillDrug
Also called Stromectol
Using a MDA approach, fieldworkers will administer ivermectin using directly observed treatment methodology to participants
Ivermectin Injectable ProductDrug
Also called Veterinary Ivermectin 1%
Veterinary ivermectin injectable will be given to livestock in the relevant cluster
| Study group | Role | What they receive |
|---|---|---|
| Albendazole | Active comparator | The albendazole group will receive a single dose of 400 mg, given once a month for three months. Generic products will be used in both countries, the final product will be GMP certified and fully bioequivalent with GSK's Albenza®. Bendex (CIPLA) in Mozambique and G-Abzole (Guilin) in Kenya. Receives: Drug: Albendazole Pill |
| Ivermectin human | Experimental | The ivermectin group will receive a single dose of 400 mcg/kg, given once a month for three months. Product to be used is Stromectol (Merck) in Mozambique and Ivermectin 3mg USP (Edenbridge) in Kenya. Receives: Drug: Ivermectin Pill |
| Ivermectin human and livestock (Mozambique only) | Experimental | The ivermectin group will receive a single dose of 400 mcg/kg, given once a month for three months. Product to be used is Stromectol (Merck). For livestock, locally registered veterinary injectable ivermectin at 1% will be used. Receives: Drug: Ivermectin Pill; Drug: Ivermectin Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety (in humans) and efficacy of ivermectin MDA, administered to humans, or humans and livestock simultaneously (only in Mozambique) for the prevention of malaria.
Efficacy:
The efficacy endpoint is primarily measured in children (under 5 years of age in Mozambique and 5-15 years old in Kenya) and safety is determined by anyone who receives the drug.
Infection incidence in the most vulnerable age group (children under 5 years of age in Mozambique and 5-15 years in Kenya) for 6 months from the moment of the first MDA round in their community. Infection incidence has been chosen as primary endpoint based on the WHOs PPC for endectocides.
Measured: 6 months
To determine the safety (in humans) and efficacy of ivermectin MDA, administered to humans, or humans and livestock simultaneously (only in Mozambique) for the prevention of malaria.
Safety:
The safety endpoint is determined by anyone who receives the drug.
Rate of adverse events (AEs) and serious adverse events (SAEs) and difference between ivermectin and albendazole.
Measured: 6 months
Secondary outcomes (16)
To assess the efficacy of the intervention using complementary methods (efficacy).
Time to first positive RDT in children in the cohort.
Measured: 6 months
To assess the efficacy of the intervention using complementary methods (efficacy).
Molecular force of infection in a subset of children in the cohort.
Measured: 6 months
To assess the efficacy of the intervention using complementary methods (efficacy).
Malaria case incidence in all ages presenting at health facility.
Measured: 6 months
To assess the efficacy of the intervention using complementary methods (efficacy).
Malaria prevalence in all ages one month after the last dose.
Measured: 6 months
To assess the efficacy of the intervention using complementary methods (efficacy).
Multiplicity of infection in all ages one month after the last dose.
Measured: 6 months
To assess the safety of the intervention with complementary methods (safety).
Observed tolerability of the dose.
Measured: 12 months
To assess the safety of the intervention with complementary methods (safety).
Rate of Suspected Unexpected Serious Adverse Reactions (SUSARs).
Measured: 12 months
To assess the safety of the intervention with complementary methods (safety).
AEs and SAEs by organ system.
Measured: 12 months
To assess the PK of the proposed ivermectin dose/regime in its relationship with efficacy and safety outcomes (efficacy and safety).
Whole blood concentrations of ivermectin in dried blood spots.
Measured: 72 hours
To assess the impact of ivermectin MDA at the proposed regimen on the prevalence of selected ectoparasitic NTDs (efficacy on NTDs and acceptability).
- Serial prevalence of scabies using a simplified version of the algorithm described by Mahe et al.
- Serial prevalence of head lice by visual inspection.
- Serial prevalence of Tunga penetrans via visual inspection of the skin in both feet and applying the Fortaleza scale.
- Serial prevalence and severity of bed bug infestation by direct questions about bedbugs in the house.
Measured: 6 months
To assess the relationship between malaria incidence in children (under 5 years in Mozambique and 5-15 years in Kenya) and community prevalence at the peak of the malaria season.
Prevalence - incidence correlation:
- Malaria infection incidence in children (under 5 years in Mozambique and 5-15 years in Kenya) in the pediatric active cohort at community and health facility levels.
Measured: 6 months
To assess the relationship between malaria incidence in children (under 5 years in Mozambique and 5-15 years in Kenya) and community prevalence at the peak of the malaria season.
Prevalence - incidence correlation:
- Malaria prevalence at all ages.
Measured: 6 months
To assess the relationship between active and passive surveillance for malaria at health facility (only Mozambique).
- Infection incidence in children at community level (active surveillance)
- Infection incidence in children at health facility level (passive surveillance)
Measured: 18 months
To assess the accuracy for malaria diagnosis of two the different malaria rapid diagnostic tests (RDTs) used in comparison to Polymerase Chain Reaction (PCR) (Mozambique).
Results correlation between HRP2 and pLDH-based RDTs
Measured: 6 months
To assess the accuracy for malaria diagnosis of two the different malaria rapid diagnostic tests (RDTs) used in comparison to PCR (Mozambique).
Results correlation between RDTs and PCR
Measured: 6 months
To assess the accuracy for malaria diagnosis of two the different malaria rapid diagnostic tests (RDTs) used in comparison to PCR (Mozambique).
Proportion of RDT negative but PCR positive infections
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start17 Mar 2022
- Primary completion15 Apr 2024
- Study completion3 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The BOHEMIA trials are open-label with random assignment to one of 3 treatment arms in Mozambique and 2 in Kenya: (a) ivermectin in humans, (b) ivermectin in humans + livestock (only in Mozambique), or (c) albendazole control.
- Masking
- None (open label)
- Enrolment
- 48,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Institute for Global Health
- Sponsor type
- University, hospital or other
- Collaborators
- UNITAID
- Responsible party
- Sponsor
- Investigators
- Regina Rabinovich, Principal investigator, Barcelona Institute of Global HealthCarlos Chaccour, Principal investigator, Barcelona Institute of Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966702
- Sponsor's protocol ID
- BOHEMIA
- Acronym
- BOHEMIA
- Status last verified
- Mar 2025
- First submitted
- 4 Jun 2021
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In order to ensure that the Project Results may be shared and ISGlobal will make the fully anonymized data generated by the Project publicly available on open access terms in an appropriate online data repository: (i) at the same time as publication, in relation to data supporting, or which may be necessary to validate, the main findings of any publication; (ii) no later than six (6) months after the end of the Project Term, in relation to all other data which may have public health value
Publications
Nicolas P, Mundaca H, Brazeal A, Houana A, Ngama M, Macucha A, Matano A, Elobolobo E, Vegove V, Martinho S, Kariuki M, Mbanze J, Mitora S, Montana J, Ringera I, Tunez L, Imputiua S, Munguambe H, Mutepa V, Soares A, Xerinda A, Materrula F, Ruiz-Castillo P, Onyango T, Casellas A, Rudd M, Jones C, Maia M, Mwangangi J, Rabinovich R, Saute F, Chaccour C. Risk of adverse pregnancy outcomes following inadvertent exposure to ivermectin during the periconception period: findings from two cluster-randomized trials in Mozambique and Kenya. EClinicalMedicine. 2026 Jul 14;97:104069. doi: 10.1016/j.eclinm.2026.104069. eCollection 2026 Jul.
PubMed 42518939Chaccour C, Nicolas P, Martinho S, Mundaca H, Elobolobo E, Ruiz-Castillo P, Houana A, Montana J, Mbanze J, Casellas A, Macucha A, Mael M, Soares A, Kiuru C, Gutierrez AS, Imputiua S, Constantino L, Vegove V, Cole G, Duthaler U, Ribes M, Mutepa V, Brew J, Munguambe H, Stanulovic S, Xerinda A, Materula F, Gorski N, Wanjiku C, Furnival-Adams J, Tunez L, Sam L, Collins L, Xia K, Hammann F, Rudd M, Rist C, Jones C, Maia M, Candrinho B, Rabinovich NR, Saute F. Ivermectin to reduce malaria transmission- safety and efficacy results from the BOHEMIA cluster randomized trial in Mozambique. EClinicalMedicine. 2025 Nov 7;90:103632. doi: 10.1016/j.eclinm.2025.103632. eCollection 2025 Dec.
PubMed 41278243Furnival-Adams J, Houana A, Saute F, Elobolobo E, Rudd M, Nicolas P, Montana J, Martinho S, Mundaca H, Mbanze J, Soares A, Imputiua S, Ruiz-Castillo P, Ribes M, Sanz A, Mamudo Sale M, Macucha A, Casellas A, Lopez V, Vegove V, Mutepa V, Munguambe H, Xerinda A, Materula F, Rabinovich NR, Engelman D, Chaccour C. Direct and indirect protection against scabies through ivermectin mass drug administration designed for malaria in Mozambique: a substudy nested within a cluster-randomised, controlled trial. Lancet Microbe. 2025 Dec;6(12):101189. doi: 10.1016/j.lanmic.2025.101189. Epub 2025 Nov 20.
PubMed 41274299Chaccour C, Maia M, Kariuki M, Ruiz-Castillo P, Wanjiku C, Kasiwa L, Brazeal A, Casellas A, Ngama M, Onyango T, Elobolobo E, Kazungu K, Mael M, Wangari W, Nuru K, Otuko R, Sanz A, Ringera I, Matano A, Mitora S, Ribes M, Brew J, Gorski N, Nicolas P, Stanulovic S, Omondi I, Furnival-Adams J, Tunez L, Mbarak J, Vegove V, Yaa E, Mramba S, Kibet Y, Nyambura N, Rotich C, Wanjiru S, Vura M, Wanjiku F, Sam L, Collins L, Xia K, Hammann F, Saute F, Rudd M, Rist C, Jones C, Mwangangi J, Rabinovich NR. Ivermectin to Control Malaria - A Cluster-Randomized Trial. N Engl J Med. 2025 Jul 24;393(4):362-375. doi: 10.1056/NEJMoa2411262.
PubMed 40700688Furnival-Adams J, Houana A, Nicolas P, Montana J, Martinho S, Casellas A, Mundaca H, Mbanze J, Soares A, Imputiua S, Ruiz-Castillo P, Ribes M, Sanz A, Sale MM, Macucha A, Elobolobo E, Vegove V, Mutepa V, Munguambe H, Xerinda A, Materula F, Rabinovich R, Saute F, Chaccour C. Collateral benefits of ivermectin mass drug administration designed for malaria against headlice in Mopeia, Mozambique: a cluster randomised controlled trial. Infect Dis Poverty. 2025 Mar 27;14(1):25. doi: 10.1186/s40249-025-01290-z.
PubMed 40140904Ruiz-Castillo P, Imputiua S, Xie K, Elobolobo E, Nicolas P, Montana J, Jamisse E, Munguambe H, Materrula F, Casellas A, Deng X, Marathe A, Rabinovich R, Saute F, Chaccour C, Sacoor C. BOHEMIA a cluster randomized trial to assess the impact of an endectocide-based one health approach to malaria in Mozambique: baseline demographics and key malaria indicators. Malar J. 2023 Jun 4;22(1):172. doi: 10.1186/s12936-023-04605-3.
PubMed 37271818Chaccour C, Casellas A, Hammann F, Ruiz-Castillo P, Nicolas P, Montana J, Mael M, Selvaraj P, Duthaler U, Mrema S, Kakolwa M, Lyimo I, Okumu F, Marathe A, Schurch R, Elobolobo E, Sacoor C, Saute F, Xia K, Jones C, Rist C, Maia M, Rabinovich NR. BOHEMIA: Broad One Health Endectocide-based Malaria Intervention in Africa-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. Trials. 2023 Feb 21;24(1):128. doi: 10.1186/s13063-023-07098-2.
PubMed 36810194
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04966702
- Acronym / sponsor ID
- BOHEMIA / BOHEMIA
- Conditions
- Malaria
- Keywords
- ivermectin, malaria, vector control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48,145 participants (actual)
- Lead sponsor
- Barcelona Institute for Global HealthUniversity, hospital or other
- Collaborators
- UNITAID
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 World Health Organization's (WHO) preferred product characteristics (PPC) for endectocides.
Detailed description
WHO's PPC states that the desired efficacy of an endectocide as stand-alone insecticide in areas of high to moderate transmission is at least 20% reduction in the incidence of clinical malaria (as primary outcome) and incidence of infection (as secondary outcome) in children under 5 years old (the highest incidence age-group in areas with high-transmission), lasting for at least 1 month following a single regimen. Assessing this effect requires a cluster-randomized design with meticulous follow-up of a cohort of children for efficacy and the whole exposed population for safety outcomes, which is the design selected for the BOHEMIA trials.
Two BOHEMIA cluster randomized trials will be carried out in Mozambique (Southern Africa) and Kenya (Eastern Africa). These sites encompass different transmission dynamics that increase the generalizability of results, namely: (a) a gradient of malaria transmission: moderate in Kenya and very high in Mozambique, (b) different species composition of vector population, (c) different rain patterns and environmental conditions, and (d) different livestock species and human/livestock ratios (in Mozambique).
Population:
Co-primary objectives are determined in different populations. Efficacy is primarily determined in a pediatric active cohort (children under 5 years of age in Mozambique and 5-15 years in Kenya), and safety is determined in anyone who receives the drug. Pregnant women and children under 15 kgs are not eligible for treatment.
Treatment Groups:
Two groups of clusters (three in Mozambique) will be randomized to receive (a) ivermectin in humans, (b) ivermectin in humans + livestock (only in Mozambique), or (c) albendazole control. In Mozambique, the study district will be subject to enhanced passive surveillance for malaria.
Primary Outcome Measure:
The primary outcome measure is proposed as incidence in a six-month period given that ivermectin is a short-acting intervention with <1% residual drug at 30 days after each dose. Efficacy assessment will continue 4 months post last dose of ivermectin, and this will include analysis of the vector population. We have proposed the appropriate duration of impact evaluation relevant to the biology of the intervention, and geared towards being able to clean the data, lock the database, and conduct the primary efficacy and safety analysis efficiently.
Estimated Duration of Study:
Throughout the study there will be two different groups of participants enrolled, the ones receiving the treatment (>15 kg) and the ones in the active pediatric cohort for the main outcome of malaria incidence (the ages of highest incidence in each country, under 5 years of age in Mozambique and 5-15 years in Kenya). Each group will participate for different periods of time.
Only the group enrolled in the active pediatric cohort will contribute to the primary efficacy outcome and this group will participate from date of first dose for six months. The group receiving treatment (>15 kg) will contribute to the primary safety outcome and several secondary outcomes (PK, Neglected Tropical Diseases [NTDs]) and this group will participate for four months. Women of child-bearing age will be visited one month after the third dose for a final pregnancy test, any pregnancy occurring during the trial will be followed until birth. The cross-sectional survey will enroll participants of all ages one month after the last Mass Drug Administration (MDA) round.
WHO guidance states that trial design and duration should reflect the nature of the intervention and are left at the discretion of researchers. These trials are robustly powered and are being conducted in moderate to high burden areas, so we believe the risk of failing to find an effect is low and if so, it would throw the utility of the intervention into question.
Advancing the development of this new tool towards implementation in the field can be accomplished in a time frame to contribute to the 2030 Global Technical Strategy (GTS) goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The BOHEMIA trials are open-label with random assignment to one of 3 treatment arms in Mozambique and 2 in Kenya: (a) ivermectin in humans, (b) ivermectin in humans + livestock (only in Mozambique), or (c) albendazole control.
| Arm | Type | Receives |
|---|---|---|
| Albendazole | Active comparator | Drug: Albendazole PillThe albendazole group will receive a single dose of 400 mg, given once a month for three months. Generic products will be used in both countries, the final product will be GMP certified and fully bioequivalent with GSK's Albenza®. Bendex (CIPLA) in Mozambique and G-Abzole (Guilin) in Kenya. |
| Ivermectin human | Experimental | Drug: Ivermectin PillThe ivermectin group will receive a single dose of 400 mcg/kg, given once a month for three months. Product to be used is Stromectol (Merck) in Mozambique and Ivermectin 3mg USP (Edenbridge) in Kenya. |
| Ivermectin human and livestock (Mozambique only) | Experimental | Drug: Ivermectin Pill, Drug: Ivermectin Injectable ProductThe ivermectin group will receive a single dose of 400 mcg/kg, given once a month for three months. Product to be used is Stromectol (Merck). For livestock, locally registered veterinary injectable ivermectin at 1% will be used. |
Who may qualify
- Ages
- 1 week to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albendazole PillAlso: Alben, BendexUsing a MDA approach, fieldworkers will administer albendazole using directly observed treatment methodology to participants | Drug | Albendazole |
| Ivermectin PillAlso: StromectolUsing a MDA approach, fieldworkers will administer ivermectin using directly observed treatment methodology to participants | Drug | Ivermectin human, Ivermectin human and livestock (Mozambique only) |
| Ivermectin Injectable ProductAlso: Veterinary Ivermectin 1%Veterinary ivermectin injectable will be given to livestock in the relevant cluster | Drug | Ivermectin human and livestock (Mozambique only) |
Primary outcome
To determine the safety (in humans) and efficacy of ivermectin MDA, administered to humans, or humans and livestock simultaneously (only in Mozambique) for the prevention of malaria.
Time frame: 6 months
Efficacy: The efficacy endpoint is primarily measured in children (under 5 years of age in Mozambique and 5-15 years old in Kenya) and safety is determined by anyone who receives the drug. Infection incidence in the most vulnerable age group (children under 5 years of age in Mozambique and 5-15 years in Kenya) for 6 months from the moment of the first MDA round in their community. Infection incidence has been chosen as primary endpoint based on the WHOs PPC for endectocides.
To determine the safety (in humans) and efficacy of ivermectin MDA, administered to humans, or humans and livestock simultaneously (only in Mozambique) for the prevention of malaria.
Time frame: 6 months
Safety: The safety endpoint is determined by anyone who receives the drug. Rate of adverse events (AEs) and serious adverse events (SAEs) and difference between ivermectin and albendazole.
16 secondary outcomes
To assess the efficacy of the intervention using complementary methods (efficacy).
Time frame: 6 months
To assess the efficacy of the intervention using complementary methods (efficacy).
Time frame: 6 months
To assess the efficacy of the intervention using complementary methods (efficacy).
Time frame: 6 months
To assess the efficacy of the intervention using complementary methods (efficacy).
Time frame: 6 months
To assess the efficacy of the intervention using complementary methods (efficacy).
Time frame: 6 months
To assess the safety of the intervention with complementary methods (safety).
Time frame: 12 months
To assess the safety of the intervention with complementary methods (safety).
Time frame: 12 months
To assess the safety of the intervention with complementary methods (safety).
Time frame: 12 months
To assess the PK of the proposed ivermectin dose/regime in its relationship with efficacy and safety outcomes (efficacy and safety).
Time frame: 72 hours
To assess the impact of ivermectin MDA at the proposed regimen on the prevalence of selected ectoparasitic NTDs (efficacy on NTDs and acceptability).
Time frame: 6 months
To assess the relationship between malaria incidence in children (under 5 years in Mozambique and 5-15 years in Kenya) and community prevalence at the peak of the malaria season.
Time frame: 6 months
To assess the relationship between malaria incidence in children (under 5 years in Mozambique and 5-15 years in Kenya) and community prevalence at the peak of the malaria season.
Time frame: 6 months
To assess the relationship between active and passive surveillance for malaria at health facility (only Mozambique).
Time frame: 18 months
To assess the accuracy for malaria diagnosis of two the different malaria rapid diagnostic tests (RDTs) used in comparison to Polymerase Chain Reaction (PCR) (Mozambique).
Time frame: 6 months
To assess the accuracy for malaria diagnosis of two the different malaria rapid diagnostic tests (RDTs) used in comparison to PCR (Mozambique).
Time frame: 6 months
To assess the accuracy for malaria diagnosis of two the different malaria rapid diagnostic tests (RDTs) used in comparison to PCR (Mozambique).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Derived from this study: PubMed 42518939Nicolas P, Mundaca H, Brazeal A, Houana A, Ngama M, Macucha A, Matano A, Elobolobo E, Vegove V, Martinho S, Kariuki M, Mbanze J, Mitora S, Montana J, Ringera I, Tunez L, Imputiua S, Munguambe H, Mutepa V, Soares A, Xerinda A, Materrula F, Ruiz-Castillo P, Onyango T, Casellas A, Rudd M, Jones C, Maia M, Mwangangi J, Rabinovich R, Saute F, Chaccour C. Risk of adverse pregnancy outcomes following inadvertent exposure to ivermectin during the periconception period: findings from two cluster-randomized trials in Mozambique and Kenya. EClinicalMedicine. 2026 Jul 14;97:104069. doi: 10.1016/j.eclinm.2026.104069. eCollection 2026 Jul.
- Derived from this study: PubMed 41278243Chaccour C, Nicolas P, Martinho S, Mundaca H, Elobolobo E, Ruiz-Castillo P, Houana A, Montana J, Mbanze J, Casellas A, Macucha A, Mael M, Soares A, Kiuru C, Gutierrez AS, Imputiua S, Constantino L, Vegove V, Cole G, Duthaler U, Ribes M, Mutepa V, Brew J, Munguambe H, Stanulovic S, Xerinda A, Materula F, Gorski N, Wanjiku C, Furnival-Adams J, Tunez L, Sam L, Collins L, Xia K, Hammann F, Rudd M, Rist C, Jones C, Maia M, Candrinho B, Rabinovich NR, Saute F. Ivermectin to reduce malaria transmission- safety and efficacy results from the BOHEMIA cluster randomized trial in Mozambique. EClinicalMedicine. 2025 Nov 7;90:103632. doi: 10.1016/j.eclinm.2025.103632. eCollection 2025 Dec.
- Derived from this study: PubMed 41274299Furnival-Adams J, Houana A, Saute F, Elobolobo E, Rudd M, Nicolas P, Montana J, Martinho S, Mundaca H, Mbanze J, Soares A, Imputiua S, Ruiz-Castillo P, Ribes M, Sanz A, Mamudo Sale M, Macucha A, Casellas A, Lopez V, Vegove V, Mutepa V, Munguambe H, Xerinda A, Materula F, Rabinovich NR, Engelman D, Chaccour C. Direct and indirect protection against scabies through ivermectin mass drug administration designed for malaria in Mozambique: a substudy nested within a cluster-randomised, controlled trial. Lancet Microbe. 2025 Dec;6(12):101189. doi: 10.1016/j.lanmic.2025.101189. Epub 2025 Nov 20.
- Derived from this study: PubMed 40700688Chaccour C, Maia M, Kariuki M, Ruiz-Castillo P, Wanjiku C, Kasiwa L, Brazeal A, Casellas A, Ngama M, Onyango T, Elobolobo E, Kazungu K, Mael M, Wangari W, Nuru K, Otuko R, Sanz A, Ringera I, Matano A, Mitora S, Ribes M, Brew J, Gorski N, Nicolas P, Stanulovic S, Omondi I, Furnival-Adams J, Tunez L, Mbarak J, Vegove V, Yaa E, Mramba S, Kibet Y, Nyambura N, Rotich C, Wanjiru S, Vura M, Wanjiku F, Sam L, Collins L, Xia K, Hammann F, Saute F, Rudd M, Rist C, Jones C, Mwangangi J, Rabinovich NR. Ivermectin to Control Malaria - A Cluster-Randomized Trial. N Engl J Med. 2025 Jul 24;393(4):362-375. doi: 10.1056/NEJMoa2411262.
- Derived from this study: PubMed 40140904Furnival-Adams J, Houana A, Nicolas P, Montana J, Martinho S, Casellas A, Mundaca H, Mbanze J, Soares A, Imputiua S, Ruiz-Castillo P, Ribes M, Sanz A, Sale MM, Macucha A, Elobolobo E, Vegove V, Mutepa V, Munguambe H, Xerinda A, Materula F, Rabinovich R, Saute F, Chaccour C. Collateral benefits of ivermectin mass drug administration designed for malaria against headlice in Mopeia, Mozambique: a cluster randomised controlled trial. Infect Dis Poverty. 2025 Mar 27;14(1):25. doi: 10.1186/s40249-025-01290-z.
- Derived from this study: PubMed 37271818Ruiz-Castillo P, Imputiua S, Xie K, Elobolobo E, Nicolas P, Montana J, Jamisse E, Munguambe H, Materrula F, Casellas A, Deng X, Marathe A, Rabinovich R, Saute F, Chaccour C, Sacoor C. BOHEMIA a cluster randomized trial to assess the impact of an endectocide-based one health approach to malaria in Mozambique: baseline demographics and key malaria indicators. Malar J. 2023 Jun 4;22(1):172. doi: 10.1186/s12936-023-04605-3.
- Derived from this study: PubMed 36810194Chaccour C, Casellas A, Hammann F, Ruiz-Castillo P, Nicolas P, Montana J, Mael M, Selvaraj P, Duthaler U, Mrema S, Kakolwa M, Lyimo I, Okumu F, Marathe A, Schurch R, Elobolobo E, Sacoor C, Saute F, Xia K, Jones C, Rist C, Maia M, Rabinovich NR. BOHEMIA: Broad One Health Endectocide-based Malaria Intervention in Africa-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. Trials. 2023 Feb 21;24(1):128. doi: 10.1186/s13063-023-07098-2.
- Individual participant dataSharing planned: Yes. In order to ensure that the Project Results may be shared and ISGlobal will make the fully anonymized data generated by the Project publicly available on open access terms in an appropriate online data repository: (i) at the same time as publication, in relation to data supporting, or which may be necessary to validate, the main findings of any publication; (ii) no later than six (6) months after the end of the Project Term, in relation to all other data which may have public health value
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Rabinovich principal investigator
Barcelona Institute of Global Health
Carlos Chaccour principal investigator
Barcelona Institute of Global Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albendazole Pill, Ivermectin Pill and Ivermectin Injectable Product in people with Malaria, run by Barcelona Institute for Global Health at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety (in humans) and efficacy of ivermectin MDA, administered to humans, or humans and livestock simultaneously (only in Mozambique) for the prevention of malaria. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04966702, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.