Leishmaniasis, CutaneousPhase 3NCT06917040
Enhancing Protection Against Vector-borne Diseases in Forcibly Displaced Communities: Evaluating the Efficacy of Spatial Repellents for Cutaneous Leishmaniasis Control in North-East Syria
A Phase 3 study testing Spatial repellant emanator in people with Leishmaniasis, Cutaneous and Vector Borne Diseases, run by The Mentor Initiative at 1 site in Syria.
Trial summary
The aim of this study is to determine the efficacy of Mosquito Shield (spatial repellent) in reducing cutaneous leishmaniasis case incidence among internally displaced persons and sandfly density in temporary shelters and camp settings in Ar-Raqqa governorate, North-East Syria. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Leishmaniasis, Cutaneous, Vector Borne Diseases
- What is being tested?
- Spatial repellant emanator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,404 participants
- Where
- 1 siteSyria
- Study dates
- 1 Feb 2021to 1 Apr 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Known history of cutaneous leishmaniasis in camp Sleeping under same shelter type (all UNHCR tents / plastic sheets) Camp easily accessible by road Camps a minimum of 5km apart Adequate security levels
Who cannot join
- Camps closer than 5km from a camp included in the study Camps with no previously recorded cases of cutaneous leishmaniasis Displaced communities living outside of defined camp settings
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the efficacy of Mosquito Shield (spatial repellent) in reducing cutaneous leishmaniasis case incidence among internally displaced persons and sandfly density in temporary shelters and camp settings in Ar-Raqqa governorate, North-East Syria.
- Conditions
- Leishmaniasis, Cutaneous, Vector Borne Diseases
- Being tested
- Spatial repellant emanator
- Keywords
- Conflict, Internally displaced people, temporary shelter, spatial repellants
- Medical subject headings
- Leishmaniasis, Cutaneous, Vector Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial repellant emanatorDevice
Spatial emanator with an active ingredient Transfluthrin (C15H12Cl2F4O2, 110mg, EPA registered number 432-1588).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 2 clusters received: 1.The study intervention was Mosquito ShieldTM. The active ingredient releases on a controlled basis over a 1-month period (1 emanator in rooms up to 18 m 2 / 2 emanator per 9 m). The households in the intervention arm were provided with Mosquito ShieldTM for 9 months (April-December 2021). This was distributed directly to households every month with pictogram instructions in the local language describing the correct intervention usage: how to open Mosquito ShieldTM, the number to be installed per room, how to attach and position Mosquito ShieldTM and the duration of Mosquito ShieldTM usage (30 days) prior to replacement. 2. IECs (brochures and posters) with information on cutaneous leishmaniasis transmission, prevention, clinical symptoms, correct treatment seeking practices and treatment locations. 3. Free of charge access to diagnostic and treatment services Receives: Device: Spatial repellant emanator |
| Control | No intervention | 4 clusters received: 1. IECs (brochures and posters) with information on cutaneous leishmaniasis transmission, prevention, clinical symptoms, correct treatment seeking practices and treatment locations. 2. Free of charge access to diagnostic and treatment services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological outcome: cutaneous leishmaniasis incidence
Cutaneous leishmaniasis incidence per 1,000 will be estimated as the total number of cutaneous leishmaniasis episodes per 1,000 persons over the course of the trial. Two different incubation times or diagnostic cut-offs will be used: at 2 months post-intervention (from August 2021 to April 2022) and at 4 months post-intervention (from August 2021 to April 2022).
Measured: 11 or 9 months
Entomological outcome: phlebotomine sandfly density
Phlebotomine sandfly density will be estimated monthly using Centers for Disease Control and Prevention light traps inside shelters.
Measured: 9 months
Secondary outcomes (1)
Intervention feasibility, acceptability and uptake
To measure community and household intervention acceptability and uptake, a questionnaire will be conducted post-intervention.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 Feb 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leishmaniasis, CutaneousStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18,404 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Mentor Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nevada, Las Vegas, Hacettepe University
- Responsible party
- Principal investigator, Richard Allan, The Mentor Initiative
- Investigators
- Richard J Allan, PhD, Principal investigator, The Mentor Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917040
- Sponsor's protocol ID
- CGCSR-Syria
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allan R, Scherrer R, Kasap OE, Paris L, Scott T, Sauskojus H, Wetherill O, Estecha-Querol S, Alkhalaf Z, Karakus M, Yilmaz A, Alten B, Messenger LA. Enhancing protection against vector-borne diseases in forcibly displaced communities: evaluating the efficacy of spatial repellents for cutaneous leishmaniasis control in North-East Syria. BMC Med. 2025 Jul 3;23(1):401. doi: 10.1186/s12916-025-04244-2.
PubMed 40611204
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Protection Against Vector-borne Diseases in Forcibly Displaced Communities: Evaluating the Efficacy of Spatial Repellents for Cutaneous Leishmaniasis Control in North-East Syria
- ClinicalTrials.gov ID
- NCT06917040
- Acronym / sponsor ID
- CGCSR-Syria
- Conditions
- Leishmaniasis, Cutaneous, Vector Borne Diseases
- Keywords
- Conflict, Internally displaced people, temporary shelter, spatial repellants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,404 participants (actual)
- Lead sponsor
- The Mentor InitiativeUniversity, hospital or other
- Collaborators
- University of Nevada, Las Vegas, Hacettepe University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 8 Apr 2025 (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 aim of this study is to determine the efficacy of Mosquito Shield (spatial repellent) in reducing cutaneous leishmaniasis case incidence among internally displaced persons and sandfly density in temporary shelters and camp settings in Ar-Raqqa governorate, North-East Syria.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Spatial repellant emanator2 clusters received: 1.The study intervention was Mosquito ShieldTM. The active ingredient releases on a controlled basis over a 1-month period (1 emanator in rooms up to 18 m 2 / 2 emanator per 9 m). The households in the intervention arm were provided with Mosquito ShieldTM for 9 months (April-December 2021). This was distributed directly to households every month with pictogram instructions in the local language describing the correct intervention usage: how to open Mosquito ShieldTM, the number to be installed per room, how to attach and position Mosquito ShieldTM and the duration of Mosquito ShieldTM usage (30 days) prior to replacement. 2. IECs (brochures and posters) with information on cutaneous leishmaniasis transmission, prevention, clinical symptoms, correct treatment seeking practices and treatment locations. 3. Free of charge access to diagnostic and treatment services |
| Control | No intervention | –4 clusters received: 1. IECs (brochures and posters) with information on cutaneous leishmaniasis transmission, prevention, clinical symptoms, correct treatment seeking practices and treatment locations. 2. Free of charge access to diagnostic and treatment services |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Known history of cutaneous leishmaniasis in camp Sleeping under same shelter type (all UNHCR tents / plastic sheets) Camp easily accessible by road Camps a minimum of 5km apart Adequate security levels
Key exclusion criteria (1 listed)
- Camps closer than 5km from a camp included in the study Camps with no previously recorded cases of cutaneous leishmaniasis Displaced communities living outside of defined camp settings
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 |
|---|---|---|
| Spatial repellant emanatorSpatial emanator with an active ingredient Transfluthrin (C15H12Cl2F4O2, 110mg, EPA registered number 432-1588). | Device | Intervention |
Primary outcome
Epidemiological outcome: cutaneous leishmaniasis incidence
Time frame: 11 or 9 months
Cutaneous leishmaniasis incidence per 1,000 will be estimated as the total number of cutaneous leishmaniasis episodes per 1,000 persons over the course of the trial. Two different incubation times or diagnostic cut-offs will be used: at 2 months post-intervention (from August 2021 to April 2022) and at 4 months post-intervention (from August 2021 to April 2022).
Entomological outcome: phlebotomine sandfly density
Time frame: 9 months
Phlebotomine sandfly density will be estimated monthly using Centers for Disease Control and Prevention light traps inside shelters.
1 secondary outcome
Intervention feasibility, acceptability and uptake
Time frame: 11 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 8 Apr 2025.
- Derived from this study: PubMed 40611204Allan R, Scherrer R, Kasap OE, Paris L, Scott T, Sauskojus H, Wetherill O, Estecha-Querol S, Alkhalaf Z, Karakus M, Yilmaz A, Alten B, Messenger LA. Enhancing protection against vector-borne diseases in forcibly displaced communities: evaluating the efficacy of spatial repellents for cutaneous leishmaniasis control in North-East Syria. BMC Med. 2025 Jul 3;23(1):401. doi: 10.1186/s12916-025-04244-2.
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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.
Richard J Allan, PhD principal investigator
The Mentor Initiative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spatial repellant emanator in people with Leishmaniasis, Cutaneous and Vector Borne Diseases, run by The Mentor Initiative at 1 site in Syria.
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 1 inclusion and 1 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 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. 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?
Epidemiological outcome: cutaneous leishmaniasis incidence (time frame: 11 or 9 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 NCT06917040, which also lists 1 linked publication.
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 8 Apr 2025.