Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202106695877303 Date of Approval: 08/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Broad One Health Endectocide-based Malaria Intervention in Africa - BOHEMIA: 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.
Official scientific title Broad One Health Endectocide-based Malaria Intervention in Africa - BOHEMIA: 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.
Brief summary describing the background and objectives of the trial Using MDA of endectocides such as ivermectin to reduce malaria transmission offers several potential advantages: 1. It would target malaria vectors feeding on treated humans regardless of the place and time of biting, effectively targeting residual transmission driven by mosquitoes that feed outside times and spaces protected by core vector control tools. 2. It would target malaria vectors that feed on livestock and that are not exposed to insecticide within the home, effectively targeting zoophagic-driven residual transmission. 3. It holds additional potential to tackle insecticide resistance given that ivermectin’s mechanism of action differs from public health insecticides currently in use. 4. It offers an opportunity for the integrated prevention of malaria and NTDs [56, 57], which may help achieve efficiencies. 5. Broader ivermectin delivery to livestock would have positive externalities on households, by reducing the burden of intestinal helminths and ecto-parasites in dominant domesticated herds. Primary objective • To determine the safety (in humans) and efficacy of ivermectin MDA (administered to humans or humans and livestock simultaneously) for the prevention of malaria. Secondary objectives To assess: • The efficacy of the intervention using complementary methods (efficacy) • The safety of the intervention with complementary methods (safety) • The PK of the proposed ivermectin dose/regime in its relationship with efficacy and safety outcomes (efficacy and safety) • The impact of ivermectin MDA at the proposed regimen on the prevalence of selected ectoparasitic NTDs • The relationship between malaria incidence in children under 5 years old in Mozambique and 5-15 years old in Kenya and community prevalence one month post last dose (Moz) • The relationship between active and passive surveillance for malaria at health facility (Moz) • To assess the accuracy for malaria diagnosis of two different malaria RDTs used in comparison to PCR
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BOHEMIA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/01/2022
Actual trial start date 17/03/2022
Anticipated date of last follow up 30/10/2024
Actual Last follow-up date 03/10/2024
Anticipated target sample size (number of participants) 53000
Actual target sample size (number of participants) 48145
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Albendazole The control group will receive a single dose of albendazole of 400 mg, orally Once a month for three months Participants will be randomised to one of three treatment arms: ivermectin in human, ivermectin in human and livestock (only Mozambique) and albendazole. Additionally, a cohort of children that have not received study drug will be followed for 6 months. 20499 Active-Treatment of Control Group
Experimental Group Ivermectin Eligible individuals in the ivermectin arm will receive a single dose of 400 mcg/kg, orally Once a month for 3 months Using a Mass Drug Administration approach, fieldworkers will administer ivermectin human to participants using a Directly Observed Treatment approach. 27646
Control Group Albendazole The control group will receive a single dose of albendazole of 400 mg, orally Once a month for three months Participants will be randomised to one of three treatment arms: ivermectin in human, ivermectin in human and livestock (only Mozambique) and albendazole. Additionally, a cohort of children that have not received study drug will be followed for 6 months. 20499 Active-Treatment of Control Group
Experimental Group Ivermectin Eligible individuals in the ivermectin arm will receive a single dose of 400 mcg/kg, orally Once a month for 3 months Using a Mass Drug Administration approach, fieldworkers will administer ivermectin human to participants using a Directly Observed Treatment approach. 27646
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 years • 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 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 (Mozambique): • Received ivermectin three weeks 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 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 18 Month(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/03/2022 World Health Organisation Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
20 Avenue Appia Geneva-27 CH-1211 Switzerland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/04/2021 Comite Institucional de Bioetica para Saude do CISM
Ethics Committee Address
Street address City Postal code Country
Rua 12, Bairro Cambeve Manhica 1121 Mozambique
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/07/2021 CEIm Hospital Clinica
Ethics Committee Address
Street address City Postal code Country
Villarroel 170 Barcelona 08036 Spain
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/10/2021 CNBS
Ethics Committee Address
Street address City Postal code Country
Av Eduardo Montlane 1008/Salvador Allende Maputo 1101 Mozambique
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/01/2023 Kenya Medical Research Institute SERU
Ethics Committee Address
Street address City Postal code Country
P.O Box 54840-00200 Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
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. End of study
Secondary Outcome • To assess the efficacy of the intervention using complementary methods (efficacy) • To assess the safety of the intervention with complementary methods (safety) • To assess the pharmacokinetics (PK) of the proposed ivermectin dose/regime in its relationship with efficacy and safety outcomes (efficacy and safety) • To assess the impact of ivermectin MDA at the proposed regimen on the prevalence of selected ectoparasitic neglected tropical diseases (NTDs). • To assess the relationship between malaria incidence in children under 5 years old in Mozambique and 5-15 years old in Kenya and community prevalence one month post last dose (Mozambique) • To assess the relationship between active and passive surveillance for malaria at health facility (Mozambique) • 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) End of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CISM Rua Samora Machel, Bairro 25 de Junho, em frente a praca dos trabalhadores Mopeia Mozambique
KEMRI pongwe-kikoneni and ramisi Kwale 90100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Unitaid 20 Avenue Appia Geneva 27 CH-1211 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Barcelona Institute for GlobalHealth Rossello 132 Barcelona 08036 Spain Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Regina Rabinovich regina.rabinovich@isglobal.org +34932271806 Rosello 132
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Director Malaria Elimination Initiative
Role Name Email Phone Street address
Public Enquiries Mary Mael mary.mael@isglobal.org +34932271806 Rossello 132
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Administrator
Role Name Email Phone Street address
Scientific Enquiries Carlos Chaccour carlos.chaccour@isglobal.org +34932271806 Rosello 132
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Chief Scientific Officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes In order to ensure that the Project Results may be shared, 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 Clinical Study Report,Informed Consent Form,Study Protocol No later than six months after the end of the project term Publicly available to interested parties
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 18/06/2024 Update Protocol Safety & Efficacy Master v6.0 Using MDA of endectocides such as ivermectin to reduce malaria transmission offers several potential advantages: 1. It would target malaria vectors feeding on treated humans regardless of the place and time of biting, effectively targeting residual transmission driven by mosquitoes that feed outside times and spaces protected by core vector control tools. 2. It would target malaria vectors that feed on livestock and that are not exposed to insecticide within the home, effectively targeting zoophagic-driven residual transmission. 3. It holds additional potential to tackle insecticide resistance given that ivermectin’s mechanism of action differs from public health insecticides currently in use. 4. It offers an opportunity for the integrated prevention of malaria and NTDs [56, 57], which may help achieve efficiencies. 5. Broader ivermectin delivery to livestock would have positive externalities on households, by reducing the burden of intestinal helminths and ecto-parasites in dominant domesticated herds; this can in turn increase income, food security, and liberate resources for re-investment in household improvement and human healthcare Primary objective ● To determine the safety (in humans) and efficacy of ivermectin MDA (administered to humans or humans and livestock simultaneously) for the prevention of malaria. Secondary objectives • To assess the efficacy of the intervention using complementary methods (efficacy) • To assess the safety of the intervention with complementary methods (safety) • To assess the pharmacokinetics (PK) of the proposed ivermectin dose/regime in its relationship with efficacy and safety outcomes (efficacy and safety) • To 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) • To assess the relationship between malaria incidence in children under 5 and community prevalence one month post last dose (this ser Using MDA of endectocides such as ivermectin to reduce malaria transmission offers several potential advantages: 1. It would target malaria vectors feeding on treated humans regardless of the place and time of biting, effectively targeting residual transmission driven by mosquitoes that feed outside times and spaces protected by core vector control tools. 2. It would target malaria vectors that feed on livestock and that are not exposed to insecticide within the home, effectively targeting zoophagic-driven residual transmission. 3. It holds additional potential to tackle insecticide resistance given that ivermectin’s mechanism of action differs from public health insecticides currently in use. 4. It offers an opportunity for the integrated prevention of malaria and NTDs [56, 57], which may help achieve efficiencies. 5. Broader ivermectin delivery to livestock would have positive externalities on households, by reducing the burden of intestinal helminths and ecto-parasites in dominant domesticated herds. Primary objective • To determine the safety (in humans) and efficacy of ivermectin MDA (administered to humans or humans and livestock simultaneously) for the prevention of malaria. Secondary objectives To assess: • The efficacy of the intervention using complementary methods (efficacy) • The safety of the intervention with complementary methods (safety) • The PK of the proposed ivermectin dose/regime in its relationship with efficacy and safety outcomes (efficacy and safety) • The impact of ivermectin MDA at the proposed regimen on the prevalence of selected ectoparasitic NTDs • The relationship between malaria incidence in children under 5 years old in Mozambique and 5-15 years old in Kenya and community prevalence one month post last dose (Moz) • The relationship between active and passive surveillance for malaria at health facility (Moz) • To assess the accuracy for malaria diagnosis of two different malaria RDTs used in comparison to PCR
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 28/03/2022 Actual start date entered 17 Mar 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 28/03/2022 Study start up delay for 2nd site 31 Jan 2023 31 Jan 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 13/02/2023 Timelines has changed 31 Jan 2024 30 Jun 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 12/12/2023 Change in the first administration date in Kenya 30 Jun 2024 30 Oct 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 11/03/2025 Update actual completion date 03 Oct 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 28/03/2022 Change in cluster formation 100000 65000
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 13/02/2023 Number of participants acording currently Recon 65000 53000
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 11/03/2025 Update final no. of participants 48145
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 28/03/2022 Final EC approval received, site in Mozambique activated Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 26/07/2022 Recruitment finished in Mozambique site while still did not start in the other site. Recruiting Active, not recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 12/12/2023 Recruiting in Kenya Active, not recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 28/02/2024 Study is continuing, participants are being examined, but new participants are not currently being recruited or enrolled Recruiting Active, not recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 11/03/2025 Update study status to completed Active, not recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 20/02/2023 Tanzania's Site has been changed to Kenya's 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 Tanzania) • Residents of the study area • Parent/guardian’s able to provide consent for minors • Minors aged 12 to 15 in Tanzania able to provide assent For livestock treatment: • Owner/guardian able to provide consent • Animal expected to spend at least one week every study month inside the cluster border 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 livestock treatment: • Owner/guardian able to provide consent • Animal expected to spend at least one week every study month inside the cluster border
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 18/06/2024 Update from Protocol Safety & Efficacy Master v6.0 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 livestock treatment: • Owner/guardian able to provide consent • Animal expected to spend at least one week every study month inside the cluster border 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 years • 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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 18/06/2024 Update from Protocol Safety & Efficacy Master v6.0 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 5.2.4. 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 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 (Mozambique): • Received ivermectin three weeks 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
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/06/2024 Update Protocol Safety & Efficacy Master v6.0 Control Group, Albendazole, The control group will receive a single dose of albendazole of 400 mg, orally, Once a month for three months, Participants will be randomised to one of three treatment arms: ivermectin in human, ivermectin in human and livestock (only Mozambique) and albendazole. Additionally, a cohort of children that have not received study drug will be followed for 6 months., 49000, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 11/03/2025 Actual total group size number Control Group, Albendazole, The control group will receive a single dose of albendazole of 400 mg, orally, Once a month for three months, Participants will be randomised to one of three treatment arms: ivermectin in human, ivermectin in human and livestock (only Mozambique) and albendazole. Additionally, a cohort of children that have not received study drug will be followed for 6 months., 49000, Active-Treatment of Control Group Control Group, Albendazole, The control group will receive a single dose of albendazole of 400 mg, orally, Once a month for three months, Participants will be randomised to one of three treatment arms: ivermectin in human, ivermectin in human and livestock (only Mozambique) and albendazole. Additionally, a cohort of children that have not received study drug will be followed for 6 months., 20499, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/06/2024 Update from Protocol Safety & Efficacy Master v6.0 Experimental Group, Ivermectin, Eligible individuals in the ivermectin arm will receive a single dose of 400 mcg/kg, orally, given once a month for three months, Once a month for 3 months, Using a Mass Drug Administration approach, fieldworkers will administer ivermectin human to participants using a Directly Observed Treatment approach., 49000, Experimental Group, Ivermectin, Eligible individuals in the ivermectin arm will receive a single dose of 400 mcg/kg, orally, Once a month for 3 months, Using a Mass Drug Administration approach, fieldworkers will administer ivermectin human to participants using a Directly Observed Treatment approach., 49000,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 11/03/2025 Final group size number Experimental Group, Ivermectin, Eligible individuals in the ivermectin arm will receive a single dose of 400 mcg/kg, orally, Once a month for 3 months, Using a Mass Drug Administration approach, fieldworkers will administer ivermectin human to participants using a Directly Observed Treatment approach., 49000, Experimental Group, Ivermectin, Eligible individuals in the ivermectin arm will receive a single dose of 400 mcg/kg, orally, Once a month for 3 months, Using a Mass Drug Administration approach, fieldworkers will administer ivermectin human to participants using a Directly Observed Treatment approach., 27646,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 18/06/2024 Update from Protocol Safety and Efficacy Master v6.0 Primary Outcome, ● To determine the safety (in humans) and efficacy of ivermectin MDA (administered to humans or humans and livestock simultaneously) for the prevention of malaria, End of study 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., End of study
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 18/06/2024 Update from Protocol Safety and Efficacy Master v6.0 Secondary Outcome, • To assess the efficacy of the intervention using complementary methods (efficacy) • To assess the safety of the intervention with complementary methods (safety) • To assess the pharmacokinetics (PK) of the proposed ivermectin dose/regime in its relationship with efficacy and safety outcomes (efficacy and safety) • To 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) • To assess the relationship between malaria incidence in children under 5 and community prevalence one month post last dose (this serves for prevalence outcomes and paves the way for future studies using prevalence as outcome which is much less resource-consuming than incidence) • 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) • 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) , End of study Secondary Outcome, • To assess the efficacy of the intervention using complementary methods (efficacy) • To assess the safety of the intervention with complementary methods (safety) • To assess the pharmacokinetics (PK) of the proposed ivermectin dose/regime in its relationship with efficacy and safety outcomes (efficacy and safety) • To assess the impact of ivermectin MDA at the proposed regimen on the prevalence of selected ectoparasitic neglected tropical diseases (NTDs). • To assess the relationship between malaria incidence in children under 5 years old in Mozambique and 5-15 years old in Kenya and community prevalence one month post last dose (Mozambique) • To assess the relationship between active and passive surveillance for malaria at health facility (Mozambique) • 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) , End of study
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 26/07/2022 Centre not going to be part of the study anymore. Project management still in the process of establishing the second trial site. IHI, TBA, Kibiti and Rufiji districts, , Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 13/02/2023 because political issues Tanzania has been changed for Kenya KEMRI, pongwe-kikoneni and ramisi, Kwale, 90100, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/03/2022 Ethics approval received FALSE, World Health Organisation Ethics Review Committee, 20 Avenue Appia , Geneva-27, CH-1211, Switzerland, 19 Feb 2021, , +41227915060, ukannae@unitaid.who.int, TRUE, World Health Organisation Ethics Review Committee, 20 Avenue Appia , Geneva-27, CH-1211, Switzerland, 19 Feb 2021, 13 Mar 2022, +41227915060, triannia@who.int, 15905_13275_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 08/06/2021 Added copy of ethics letter TRUE, Comite Institucional de Bioetica para Saude do CISM, Rua 12, Bairro Cambeve, Manhica, 1121, Mozambique, , 23 Apr 2021, +25821810002, sozinho.acacio@manhica.net, TRUE, Comite Institucional de Bioetica para Saude do CISM, Rua 12, Bairro Cambeve, Manhica, 1121, Mozambique, , 23 Apr 2021, +25821810002, sozinho.acacio@manhica.net, 15905_13276_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/02/2023 The Clinical Trial will not be carried out in Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/02/2023 The Clinical Trial will not be carried out in Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/03/2022 Ethics approval received FALSE, CEIm Hospital Clinica, Villarroel 170, Barcelona, 08036, Spain, 01 Jun 2021, , +34932275400, ceic@clinic.cat, TRUE, CEIm Hospital Clinica, Villarroel 170, Barcelona, 08036, Spain, 01 Jun 2021, 22 Jul 2021, +34932275400, ceic@clinic.cat, 15905_13279_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/03/2022 Ethics approval received FALSE, CNBS, Av Eduardo Montlane 1008/Salvador Allende, Maputo, 1101, Mozambique, 14 May 2021, , +258430814, person@misau.gov.mz, TRUE, CNBS, Av Eduardo Montlane 1008/Salvador Allende, Maputo, 1101, Mozambique, 14 May 2021, 18 Oct 2021, +258430814, person@misau.gov.mz, 15905_13280_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/02/2023 approval of new Site TRUE, Kenya Medical Research Institute SERU, P.O Box 54840-00200, Nairobi, 00200, Kenya, , 28 Jan 2023, +2540202722541, ddrt@kemri.go.ke, TRUE, Kenya Medical Research Institute SERU, P.O Box 54840-00200, Nairobi, 00200, Kenya, , 28 Jan 2023, +2540202722541, ddrt@kemri.go.ke, 15905_23139_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 13/02/2023 Tanzania site has benn changed for Kenya site TRUE, Kenya Medical Research Institute SERU, P.O Box 54840-00200, Nairobi, 00200, Kenya, , 28 Jan 2023, +2540202722541, ddrt@kemri.go.ke,