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.: PACTR202001893991170 Date of Approval: 30/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title BOHEMIA Pk400
Official scientific title Mosquitocidal effect and pharmacokinetics of different ivermectin dose regimens in preparation for BOHEMIA cluster randomized controlled trial.
Brief summary describing the background and objectives of the trial Ivermectin is an endectocide that has been used for decades in mass drug administration (MDA) campaigns against various neglected tropical diseases (NTDs). There is recent interest in re-purposing the compound for malaria vector control as MDA campaigns may have an impact on transmission by reducing the survival of mosquitoes post blood feeding. BOHEMIA (Broad One Health Endectocide-based Malaria Intervention in Africa) is a research consortium that aims at investigating ivermectin MDA to humans and livestock through two double-blinded cluster randomised controlled trials in Mozambique and Tanzania. The most appropriate dose and frequency of ivermectin MDA for malaria vector control is not yet established. A single monthly dose of ivermectin is operationally more convenient, and likely to be better adhered to by communities. On the other hand, a monthly 3-day regimen of ivermectin has been reported as safe and is already being investigated in the field for this purpose. The current study is being conducted in preparation for BOHEMIA and proposes to compare the pharmacokinetics and mosquito-killing effect of 300 mcg/Kg of IVM given on three consecutive days to 400mcg/Kg of IVM given once. We also wish to rule out any mosquitocidal effect caused by albendazole which is being considered as a comparator for BOHEMIA. Primary objective: To determine cumulative mosquito mortality up to 28 days post blood feeding on volunteers who have been treated with: a. Single oral dose ivermectin 400 mcg/Kg of ivermectin given once (400 mcg/Kg x 1 day); or b. Single oral dose of 300 mcg/Kg of ivermectin given on 3 consecutive days (300 mcg/Kg x 3 days); or c. Single oral dose of albendazole 400 mg; or d. No treatment (control). Secondary objective: To describe the pharmacokinetics of ivermectin during the first 7 days post treatment for each of the following IVM dose regimens: A. Ivermectin 400 mcg/Kg x 1 day; B. Ivermectin 300 mcg/Kg x 3 consecutive days;
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BOHEMIA PK400
Disease(s) or condition(s) being studied Infections and Infestations,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Malaria,PK/PD of ivermectin in relation to malaria vector control
Purpose of the trial Endectocide
Anticipated trial start date 03/08/2021
Actual trial start date
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date 21/06/2022
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants)
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
Experimental Group Repeated ivermectin Ivermectin 300 mcg/Kg once daily for three consecutive days. The treatment is concluded in 3 days. Oral single dose of ivermectin 300 mcg/Kg taken once a day for three consecutive days. 6
Experimental Group Single high dose ivermectin Single dose ivermectin 400 mcg/Kg Treatment is concluded after single dose intake. Oral single high dose of ivermectin (400 mcg/Kg) taken once. 12
Experimental Group Albendazole Single dose 400mg Treatment is concluded after single dose intake. Oral 400mg albendazole taken once. 6
Control Group No treatment No treatment The participant will not be given any treatment. 6 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Male or female 18 - 45 years old; ii. Body weight over 50Kg; iii. Good health or no medical conditions that could interfere with the study according to the opinion of the study clinician; iv. Willingness to participate voluntarily in all study procedures; v. Plans to remain available for study participation within the next 7 months; vi. Use of effective method of contraception documented through a family planning card for the duration of study for female participants; vii. Ability to give informed consent and communicate with the study personnel. i. Feeling sick or presenting signs of sickness, which are considered by the project physician to not be temporary condition or likely to resolve before pre-enrolment screening; ii. Body weight below 50Kg; iii. Positive for malaria rapid diagnostic test (mRDT); iv. Lactating or pregnant verified through ß-hCG urine test; v. Clinically significant laboratory abnormality as judged by the study clinician; vi. Receiving or having received in the past 30 days treatments that could, in the eyes of the investigator, interfere with the study; vii. Hypersensitivity against any of the study drugs. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 16/08/2019 Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
KENYA MEDICAL RESEARCH INSTITUTE SCIENTIFIC AND ETHICS REVIEW UNIT P.O. BOX 54840 00200 OFF MBAGATHI ROAD, NAIROBI, KENYA HOUSE NUMBER 8, KEMRI HEADQUARTERS Nairobi 00200 Kenya
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 17/10/2019 Oxford Tropical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Oxford Research Services, University Offices Wellington Square Oxford 00000 United Kingdom
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 07/10/2019 World Health Organization Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Avenue Appia 20 Geneva 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 31/05/2019 University Hospital Barcelona Ethics Committee on Drug Research
Ethics Committee Address
Street address City Postal code Country
Carrer Villaroel 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 21/11/2019 Bern Canton Committee for Ethics Research
Ethics Committee Address
Street address City Postal code Country
Murtenstrasse 31 Bern 3010 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mosquito survival up to 28 days post blood feeding will be assessed by measuring the daily proportion of knocked-down mosquitoes after feeding on blood from participants up to 28 days post treatment with either ivermectin 300mcg/Kg x3, single dose ivermectin 400mcg/Kg x1, single dose albendazole 400mg or no treatment D0 4h, D7, D10, D14, D21 and D28.
Secondary Outcome Ivermectin plasma concentration ng/L D0 1h, D0 2h, D0 3h, D0 4h, D0 5h, D0 6h, D0 8h, D0 10h, D1, D2, D3, D4, and D7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI Wellcome Trust Research Programme KEMRI square, Off hospital Rd Kilifi 80108 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
UNITAID Global Health Campus, Chemin du Pommier 40, 5th floor, Grand-Saconnex Geneva 1218 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Research Services, University Offices Wellington Square, Oxford 0000 United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
IS Global Carrer Rossello, 132 Barcelona 08036 Spain
University of Basel Petersplatz 1 Basel 4001 Switzerland
University Hospital Bern Freiburgstrasse 18 Bern 3010 Switzerland
University of Pwani Malindi Road Kilifi 80108 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marta Maia mmaia@kemri-wellcome.org +254791639964 KEMRI Wellcome Trust Research Programme, Off hospital Road, Administration building, Office 214
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Researcher
Role Name Email Phone Street address
Public Enquiries Marta Maia mmaia@kemri-wellcome.org +254791639964 KEMRI Wellcome Trust Research Programme, Off hospital Road, Administration building, Office 214
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Researcher
Role Name Email Phone Street address
Scientific Enquiries Marta Maia mmaia@kemri-wellcome.org +254791639964 KEMRI Wellcome Trust Research Programme, Off hospital Road, Administration building, Office 214
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results will be published in international peer-reviewed open-access journals and presented at national and/or international conferences. Anonymized data will be shared through online data repositories for non commercial purpose and made accessible upon approval from the principal investigator and the institutional data governance committee. Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 6 months of publication of the primary outcomes of the study. Controlled access upon approval from PI and institutional data governance committee.
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