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.: PACTR202406779622099 Date of Approval: 04/06/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Repellents for loiasis prevention
Official scientific title Evaluation of arthropod repellents in their efficacy to avoid Chrysops bites in a high transmission region for loiasis in Gabon
Brief summary describing the background and objectives of the trial Loiasis is a parasitic disease most prevalent in central Africa. It is transmitted by the bite of the Chrysops fly. Currently it is unclear how to prevent Chrysops bites. Here we evaluate current repellents for their efficacy to prevent Chrysops bites. This study is designed as a parallel arm randomized controlled clinical trial using topical repellents in comparison to placebo for the prevention of Chrysops bites. The unit of randomization is the entomological assistants who are randomized for each catchment session to one intervention group (active repellent or placebo), and to one of three locations in which the fly catching is performed. After each session the randomisation is performed anew. To avoid spill-over effect diligent washing of the skin exposed to the intervention is performed. The sample size is calcuated based on the demonstration of a statistically significant difference between the intervention group and the placebo based on alpha<0.05 and beta>0.8 assuming a median reduction of Chrysops bites by 60%.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RepChrysLoa
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Loiasis
Purpose of the trial Prevention
Anticipated trial start date 12/05/2024
Actual trial start date
Anticipated date of last follow up 30/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 204
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Icaridin 20 percent lotion once applied to skin per session 3 hours The repellent which consists of 20% Icardine lotion is applied locally to the skin of the participant. The lotion is left to dry before the observation period begins. 68
Experimental Group DEET 30 Deet 30% skin lotion once per session 3 hours The repellent which consists of 30% DEET lotion is applied locally to the skin of the participant. The lotion is left to dry before the observation period begins. 68
Control Group Ethanol once per session 3 hours the inactive placebo which consist of ethanol only is applied to the skin. It is left to dry before the observation period 68 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age >18 years Written informed consent No acute illness Inability to provide written informed consent Adult: 19 Year-44 Year 0 Year(s) 100 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 12/03/2024 Comite d ethic institutionelle du CERMEL
Ethics Committee Address
Street address City Postal code Country
BP118 Lambarene BP118 Gabon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of blood meal attempts by Chrysops fly during entire 3 hours session
Secondary Outcome Number of landings on unexposed body parts covered by clothing Number of landings on exposed skin body parts Number of seconds each landed Chrysops on exposed skin. Impact of time on preventive efficacy of repellent, impact of sex on preventive efficacy, impact of climate data on protective efficacy, impact of infection status on protective efficacy during entire 3 hours period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherches de Lambarene Institut en Recherche de Sante de Sindara BP118 Lambarene Sindara BP118 Gabon
FUNDING SOURCES
Name of source Street address City Postal code Country
German Center for Infection Research Hamburg-Lbeck-Borstel-Riems Hamburg Germany
GIZ Hamburg Hamburg Germany
Bernhard Nocht Institute for Tropical Medicine Bernhard Nocht Strasse 74 Hamburg 20359 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bernhard Nocht Institute for Tropical Medicine Bernhard Nocht Institute for Tropical Medicine Hamburg 20359 Germany Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Bernhard Nocht Institute for Tropical Medicine Bernhard Nocht Strasse 74 Hamburg 20359 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Michael Ramharter ramharter@bnitm.de +49402853800 Bernhard Nocht Strasse 74
City Postal code Country Position/Affiliation
Hamburg 20359 Germany Head of Department
Role Name Email Phone Street address
Principal Investigator Ayola Akim Adegnika aadegnika@cermel.org +24177406464 BP 242
City Postal code Country Position/Affiliation
Lambarene BP242 Gabon Director
Role Name Email Phone Street address
Public Enquiries Michael Ramharter ramharter@bnitm.de +49402853800 Bernhard Nocht Strasse 74
City Postal code Country Position/Affiliation
Hamburg 20359 Germany Head of Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data will be shared by the Sponsor of the clinical trial. All individual participant data collected during the trial will be shared after deidentification Clinical Study Report Individual participant data will be made available immediately after publication for for a period of 3 years. Summary results will also be shared immediately after publication for a period of 3 years. All individuals and institutions may request access to the data for academic non-commercial purposes. Data will be made available in a data repository.
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