LeishmaniasisLEISHChallengeNCT04512742
A Clinical Study to Develop a Controlled Human Infection Model Using Leishmania Major-infected Sand Flies
A study testing biting by Phlebotomus duboscqi infected with Leishmania major in people with Leishmaniasis and Cutaneous Leishmaniases, run by University of York at 1 site in United Kingdom.
Trial summary
The disease leishmaniasis mainly occurs in hot and tropical countries, affects millions of people and causes around 20,000 deaths across the world every year. Leishmaniasis is caused by the Leishmania parasite and is transmitted by sand flies. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Leishmaniasis, Cutaneous Leishmaniases, Insect Bites
- What is being tested?
- biting by Phlebotomus duboscqi infected with Leishmania major
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2021to 1 Nov 2023
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 50 years on the day of screening
- Willing to give consent for exposure to Leishmania-infected sand fly with the intention of causing a cutaneous leishmaniasis lesion
- Willing and able to give written informed consent
- Willing to undergo Hepatitis B, Hepatitis C \& HIV testing
- Willing to undergo a pregnancy test during screening and follow-up visits and must not be breastfeeding
- Willing to refrain from blood donation during the study
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- Using a reliable and effective form of contraception (pre-menopausal female participants)
- Judged, in the opinion of a medically qualified Clinical Investigator, to be able and likely to comply with all study requirements as set out in the protocol
- Without any other significant health problems as determined by medical history, physical examination, results of screening tests and the clinical judgment of a medically qualified Clinical Investigator
- Available for the duration of the study
- Willing to refrain from travel to regions where Leishmania-transmitting sand flies are present, from recruitment until an appropriate point (judged by study investigators).
- Willing to consent to a copy of the past medical history to be provided by the participants GP (General Practitioner) practice.
- Agree to registration on a national database of study \& trial subjects to prevent over-volunteering (TOPS)
- Willing to give consent for study investigators to contact the participants GP in the event of a significant abnormality being observed
- Willing to show identification documents to confirm identity
- Willing to give consent to biopsy(s) of suspected cutaneous leishmaniasis lesions
Who cannot join
- Receipt of any vaccine within 21 days of screening
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned study.
- History of significant allergic disease/atopy (e.g. eczema, hay fever, asthma) or reactions; or a history of severe or multiple allergies to drugs or pharmaceutical agents, as judged by the clinical investigators
- Any significant chronic skin condition as judged by the clinical investigators
- Any history of confirmed Leishmaniasis infection
- Any history of travel within the last 30 days to regions where Leishmania major-transmitting sand flies are endemic*.
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- Any history of more than 30 continuous days stay in regions where Leishmania major-transmitting sand flies are endemic within the last 10 years*.
- Any history of severe local or general reaction to insect bites, defined as
- Local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
- General: fever ≥ 39.5°C, anaphylaxis, bronchospasm, laryngeal oedema, collapse, convulsions or encephalopathy within 48 hours
- Any history of anaphylaxis
- Females - current pregnancy, less than 12 weeks postpartum, lactating or willingness/intention to become pregnant during the study.
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests as judged by study investigators
- Total IgE (immunoglobulin E) levels > 214 IU/ml
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months
- A diagnosis of diabetes type 1 or type 2 or significantly raised HbA1c (>48mmol/mol)
- Active Tuberculosis, leprosy, or malnutrition
- Any significant chronic illness requiring hospital specialist input as judged by study investigators
- Any significant psychiatric conditions as judged by general practitioner and/or study clinical team
- Unlikely to comply with the study protocol
- Participating in significant current or recent research (involving an investigational medicinal product or other significant intervention) within the past 3 months (as judged by study investigators)
- Any other significant disease, disorder, finding or medical history, which, in the opinion of a medically qualified Clinical Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Translational Research Facility, Department of Biology, University of York
York, North Yorkshire
About this study
The disease leishmaniasis mainly occurs in hot and tropical countries, affects millions of people and causes around 20,000 deaths across the world every year. Leishmaniasis is caused by the Leishmania parasite and is transmitted by sand flies. The parasite is tiny and not visible to the naked eye, whereas the sand fly is visible but small and inconspicuous.
There are different types of leishmaniasis which can affect the skin (cutaneous leishmaniasis) or the internal organs of the body (visceral leishmaniasis). Some of the milder forms will produce skin problems which will be localised, whilst other forms of leishmaniasis will cause widespread skin changes. The skin lesions of cutaneous leishmaniasis can be disfiguring if left untreated.
Read more
There are some treatments for leishmaniasis but many of them are not easy to use or don't work well. Therefore, new treatments are needed including vaccines that prevent or work against leishmaniasis.
A solution being adopted for other diseases, which the investigators now wish to adopt for leishmaniasis is to develop a 'Controlled human infection model' (CHIM). These models involve deliberate exposure of individuals to an infection, in order to better understand how the disease works and to test potential vaccines and treatments. They have contributed knowledge that has led to advances in the development of treatments.
This is study builds on an our initial successful study, FLYBITE, where uninfected (disease-free) sand flies were used to test the safety aspects and ensure that sand flies were able to bite human participants in a controlled environment. The investigators observed no major adverse effects and it was well tolerated by participants. The investigators therefore wish to proceed to a study using sand flies infected with a form of leishmaniasis that causes localised skin disease and is treatable, on the pathway to assessing future vaccines.
Read the detailed description
This is a clinical study in up to twelve healthy Leishmania-naïve subjects aged between 18 and 50 years old who develop a confirmed sand fly bite. Initially six subjects will be studied and exposed to biting by Phlebotomus duboscqi infected by Leishmania major. An adaptive design will be used, that has been pragmatically designed to minimise unnecessary exposure of volunteers to Leishmania and maximise the likelihood of developing a reproducible Controlled Human Infection Model.
The primary objective is the development of a controlled human infection model of Leishmania major using sand fly transmission which is (a) effective and (b) safe.
The first six subjects will be exposed to biting by Phlebotomus duboscqi (sand fly species) infected by Leishmania major (species of leishmaniasis causing cutaneous, ie skin disease) and assess the 'take rate', that is the number of subjects developing parasitologically confirmed cutaneous leishmaniasis (PCCL) lesions. If 6/6 subjects develop PCCL lesions no further recruitment will take place; if only < 6 subjects develop PCCL lesions, then an adaptive design will be followed.
This study is based on an initial study, entitled FLYBITE (clinicaltrials.gov identifier: NCT03999970).
the FLYBITE study was a clinical study to develop a sand fly biting protocol using pathogen-free blood-fed sand flies. Twelve healthy participants were enrolled into the study and all 12 participants experienced at least one successful sand fly bite.
- Conditions
- Leishmaniasis, Cutaneous Leishmaniases, Insect Bites
- Being tested
- biting by Phlebotomus duboscqi infected with Leishmania major
- Keywords
- Leishmaniasis, Cutaneous Leishmaniases, Controlled Human Infection Model, Human Challenge, Sand Fly, Phlebotomus
- Medical subject headings
- Leishmaniasis, Leishmaniasis, Cutaneous, Insect Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biting by Phlebotomus duboscqi infected with Leishmania majorOther
The first six subjects will be exposed to biting by Phlebotomus duboscqi infected by Leishmania major and assess the 'take rate', that is the number of subjects developing parasitologically confirmed cutaneous leishmaniasis (PCCL) lesions. If 6/6 subjects develop PCCL lesions no further recruitment will take place; if only < 6 subjects develop PCCL lesions, then an adaptive design will be followed.
| Study group | Role | What they receive |
|---|---|---|
| Leishmania infected-Phlebotomus duboscqi human challenge | Other | There is no clear indication in the medical literature to determine which of the major sand fly vectors of Leishmania major - Phlebotomus papatasi or Phlebotomus duboscqi, will be most effective at transmitting infection to a human host. Both species have a similar mode of feeding and can support L. major development. In our previous study, FLYBITE, no significant difference in biting rates on humans was observed. Based on pre-clinical data , Phlebotomus duboscqi was determined to be the lead candidate for use in this study. If all the 6 participants have developed lesions within the 6-month follow up after Leishmania challenge, the challenge phase of the study is completed. If only 5 participants have developed lesions, then a further 6 participants will undergo Leishmania challenge by P. duboscqi. If only 4 or less subjects in the first cohort develop lesions, then the investigators will switch vector to P. papatasi and a further 6 subjects will undergo Leishmania challenge. Receives: Other: biting by Phlebotomus duboscqi infected with Leishmania major |
What is being measured
The primary outcome is the main question the study is designed to answer.
The take rate of parasitologically confirmed cutaneous leishmaniasis lesions in study subjects
As the purpose is to develop a Controlled Human Infection Model with a high take rate, and as curative interventions will be carried out very early in the disease course, the P. duboscqi sand fly infected by Leishmania major has been chosen for the first six eligible and consented volunteers.
The investigators will assess the 'take rate', that is the number of subjects developing parasitologically confirmed cutaneous leishmaniasis (PCCL) lesions. If 6/6 subjects develop PCCL lesions no further recruitment will take place; if only < 6 subjects develop PCCL lesions, then the investigators will follow an adaptive design.
Measured: 1 year
Determine rate of adverse events, determined by data collection through history, clinical examination & blood tests.
The development of any study-associated serious adverse events or grade 3 adverse events at day 3 post-biting will result in a temporary halt and review of the sand fly biting schedule. Therefore the investigators will review the safety outcomes 3 days after all biting procedures in real time for each pair of subjects.
Successful treatment of cutaneous leishmaniasis lesions in participants, and absence of lesions at 1 year follow up.
Measured: 1 year
Secondary outcomes (4)
Determine rate of cutaneous leishmaniasis lesion development following infected sand fly bite
As determined by clinical examination, then biopsy and parasitological confirmation
Measured: 1 year
Determine response to Leishmania major-infected sand fly bite in terms of immunohistology and immunopathology
Analysis of immune and inflammatory response (for example macrophage and T cell phenotype) and histology compatible with CL.
Measured: 1 year
Determine parasite load in cutaneous leishmaniasis lesions in comparison to number of sand fly bites received and rate of lesion development
By polymerase chain reaction (PCR) analysis of biopsy tissue of lesion site
Measured: 1 year
Determine acceptance and psychological impact of Leishmania major-infected sand fly challenge
Using psychometric questionnaires and focus groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start16 Oct 2021
- Primary completion30 Nov 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeishmaniasisStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Controlled human infection study, with an adaptive design. The first six subjects will be exposed to biting by Phlebotomus duboscqi infected by Leishmania major and assess the 'take rate', that is the number of subjects developing parasitologically confirmed cutaneous leishmaniasis (PCCL) lesions. If 6/6 subjects develop PCCL lesions no further recruitment will take place; if only \< 6 subjects develop PCCL lesions, then an adaptive design will be followed as described elsewhere.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of York
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Department for International Development, United Kingdom
- Responsible party
- Principal investigator, Paul Kaye, University of York
- Investigators
- Charles Lacey, BMBS, MD, Principal investigator, University of York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512742
- Sponsor's protocol ID
- LEISH_Challenge
- Acronym
- LEISHChallenge
- Status last verified
- Nov 2023
- First submitted
- 11 Aug 2020
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parkash V, Ashwin H, Dey S, Sadlova J, Vojtkova B, Van Bocxlaer K, Wiggins R, Thompson D, Dey NS, Jaffe CL, Schwartz E, Volf P, Lacey CJN, Layton AM, Kaye PM. Safety and reactogenicity of a controlled human infection model of sand fly-transmitted cutaneous leishmaniasis. Nat Med. 2024 Nov;30(11):3150-3162. doi: 10.1038/s41591-024-03146-9. Epub 2024 Aug 2.
PubMed 39095597Parkash V, Jones G, Martin N, Steigmann M, Greensted E, Kaye P, Layton AM, Lacey CJ. Assessing public perception of a sand fly biting study on the pathway to a controlled human infection model for cutaneous leishmaniasis. Res Involv Engagem. 2021 May 30;7(1):33. doi: 10.1186/s40900-021-00277-y.
PubMed 34053461
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Develop a Controlled Human Infection Model Using Leishmania Major-infected Sand Flies
- ClinicalTrials.gov ID
- NCT04512742
- Acronym / sponsor ID
- LEISHChallenge / LEISH_Challenge
- Conditions
- Leishmaniasis, Cutaneous Leishmaniases, Insect Bites
- Keywords
- Leishmaniasis, Cutaneous Leishmaniases, Controlled Human Infection Model, Human Challenge, Sand Fly, Phlebotomus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of YorkUniversity, hospital or other
- Collaborators
- Medical Research Council, Department for International Development, United Kingdom
- Study start
- 16 Oct 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 13 Aug 2020 (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 disease leishmaniasis mainly occurs in hot and tropical countries, affects millions of people and causes around 20,000 deaths across the world every year. Leishmaniasis is caused by the Leishmania parasite and is transmitted by sand flies. The parasite is tiny and not visible to the naked eye, whereas the sand fly is visible but small and inconspicuous.
There are different types of leishmaniasis which can affect the skin (cutaneous leishmaniasis) or the internal organs of the body (visceral leishmaniasis). Some of the milder forms will produce skin problems which will be localised, whilst other forms of leishmaniasis will cause widespread skin changes. The skin lesions of cutaneous leishmaniasis can be disfiguring if left untreated.
There are some treatments for leishmaniasis but many of them are not easy to use or don't work well. Therefore, new treatments are needed including vaccines that prevent or work against leishmaniasis.
A solution being adopted for other diseases, which the investigators now wish to adopt for leishmaniasis is to develop a 'Controlled human infection model' (CHIM). These models involve deliberate exposure of individuals to an infection, in order to better understand how the disease works and to test potential vaccines and treatments. They have contributed knowledge that has led to advances in the development of treatments.
This is study builds on an our initial successful study, FLYBITE, where uninfected (disease-free) sand flies were used to test the safety aspects and ensure that sand flies were able to bite human participants in a controlled environment. The investigators observed no major adverse effects and it was well tolerated by participants. The investigators therefore wish to proceed to a study using sand flies infected with a form of leishmaniasis that causes localised skin disease and is treatable, on the pathway to assessing future vaccines.
Detailed description
This is a clinical study in up to twelve healthy Leishmania-naïve subjects aged between 18 and 50 years old who develop a confirmed sand fly bite. Initially six subjects will be studied and exposed to biting by Phlebotomus duboscqi infected by Leishmania major. An adaptive design will be used, that has been pragmatically designed to minimise unnecessary exposure of volunteers to Leishmania and maximise the likelihood of developing a reproducible Controlled Human Infection Model.
The primary objective is the development of a controlled human infection model of Leishmania major using sand fly transmission which is (a) effective and (b) safe.
The first six subjects will be exposed to biting by Phlebotomus duboscqi (sand fly species) infected by Leishmania major (species of leishmaniasis causing cutaneous, ie skin disease) and assess the 'take rate', that is the number of subjects developing parasitologically confirmed cutaneous leishmaniasis (PCCL) lesions. If 6/6 subjects develop PCCL lesions no further recruitment will take place; if only < 6 subjects develop PCCL lesions, then an adaptive design will be followed.
This study is based on an initial study, entitled FLYBITE (clinicaltrials.gov identifier: NCT03999970).
the FLYBITE study was a clinical study to develop a sand fly biting protocol using pathogen-free blood-fed sand flies. Twelve healthy participants were enrolled into the study and all 12 participants experienced at least one successful sand fly bite.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Controlled human infection study, with an adaptive design. The first six subjects will be exposed to biting by Phlebotomus duboscqi infected by Leishmania major and assess the 'take rate', that is the number of subjects developing parasitologically confirmed cutaneous leishmaniasis (PCCL) lesions. If 6/6 subjects develop PCCL lesions no further recruitment will take place; if only < 6 subjects develop PCCL lesions, then an adaptive design will be followed as described elsewhere.
| Arm | Type | Receives |
|---|---|---|
| Leishmania infected-Phlebotomus duboscqi human challenge | Other | Other: biting by Phlebotomus duboscqi infected with Leishmania majorThere is no clear indication in the medical literature to determine which of the major sand fly vectors of Leishmania major - Phlebotomus papatasi or Phlebotomus duboscqi, will be most effective at transmitting infection to a human host. Both species have a similar mode of feeding and can support L. major development. In our previous study, FLYBITE, no significant difference in biting rates on humans was observed. Based on pre-clinical data , Phlebotomus duboscqi was determined to be the lead candidate for use in this study. If all the 6 participants have developed lesions within the 6-month follow up after Leishmania challenge, the challenge phase of the study is completed. If only 5 participants have developed lesions, then a further 6 participants will undergo Leishmania challenge by P. duboscqi. If only 4 or less subjects in the first cohort develop lesions, then the investigators will switch vector to P. papatasi and a further 6 subjects will undergo Leishmania challenge. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy adults aged 18 to 50 years on the day of screening
- Willing to give consent for exposure to Leishmania-infected sand fly with the intention of causing a cutaneous leishmaniasis lesion
- Willing and able to give written informed consent
- Willing to undergo Hepatitis B, Hepatitis C \& HIV testing
- Willing to undergo a pregnancy test during screening and follow-up visits and must not be breastfeeding
Key exclusion criteria (22 listed)
- Receipt of any vaccine within 21 days of screening
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned study.
- History of significant allergic disease/atopy (e.g. eczema, hay fever, asthma) or reactions; or a history of severe or multiple allergies to drugs or pharmaceutical agents, as judged by the clinical investigators
- Any significant chronic skin condition as judged by the clinical investigators
- Any history of confirmed Leishmaniasis infection
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 |
|---|---|---|
| biting by Phlebotomus duboscqi infected with Leishmania majorThe first six subjects will be exposed to biting by Phlebotomus duboscqi infected by Leishmania major and assess the 'take rate', that is the number of subjects developing parasitologically confirmed cutaneous leishmaniasis (PCCL) lesions. If 6/6 subjects develop PCCL lesions no further recruitment will take place; if only < 6 subjects develop PCCL lesions, then an adaptive design will be followed. | Other | Leishmania infected-Phlebotomus duboscqi human challenge |
Primary outcome
The take rate of parasitologically confirmed cutaneous leishmaniasis lesions in study subjects
Time frame: 1 year
As the purpose is to develop a Controlled Human Infection Model with a high take rate, and as curative interventions will be carried out very early in the disease course, the P. duboscqi sand fly infected by Leishmania major has been chosen for the first six eligible and consented volunteers. The investigators will assess the 'take rate', that is the number of subjects developing parasitologically confirmed cutaneous leishmaniasis (PCCL) lesions. If 6/6 subjects develop PCCL lesions no further recruitment will take place; if only < 6 subjects develop PCCL lesions, then the investigators will follow an adaptive design.
Determine rate of adverse events, determined by data collection through history, clinical examination & blood tests.
Time frame: 1 year
The development of any study-associated serious adverse events or grade 3 adverse events at day 3 post-biting will result in a temporary halt and review of the sand fly biting schedule. Therefore the investigators will review the safety outcomes 3 days after all biting procedures in real time for each pair of subjects. Successful treatment of cutaneous leishmaniasis lesions in participants, and absence of lesions at 1 year follow up.
4 secondary outcomes
Determine rate of cutaneous leishmaniasis lesion development following infected sand fly bite
Time frame: 1 year
Determine response to Leishmania major-infected sand fly bite in terms of immunohistology and immunopathology
Time frame: 1 year
Determine parasite load in cutaneous leishmaniasis lesions in comparison to number of sand fly bites received and rate of lesion development
Time frame: 1 year
Determine acceptance and psychological impact of Leishmania major-infected sand fly challenge
Time frame: 1 year
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 9 Nov 2023.
- Derived from this study: PubMed 39095597Parkash V, Ashwin H, Dey S, Sadlova J, Vojtkova B, Van Bocxlaer K, Wiggins R, Thompson D, Dey NS, Jaffe CL, Schwartz E, Volf P, Lacey CJN, Layton AM, Kaye PM. Safety and reactogenicity of a controlled human infection model of sand fly-transmitted cutaneous leishmaniasis. Nat Med. 2024 Nov;30(11):3150-3162. doi: 10.1038/s41591-024-03146-9. Epub 2024 Aug 2.
- Derived from this study: PubMed 34053461Parkash V, Jones G, Martin N, Steigmann M, Greensted E, Kaye P, Layton AM, Lacey CJ. Assessing public perception of a sand fly biting study on the pathway to a controlled human infection model for cutaneous leishmaniasis. Res Involv Engagem. 2021 May 30;7(1):33. doi: 10.1186/s40900-021-00277-y.
- Individual participant dataSharing planned: No
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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.
Charles Lacey, BMBS, MD principal investigator
University of York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biting by Phlebotomus duboscqi infected with Leishmania major in people with Leishmaniasis and Cutaneous Leishmaniases, run by University of York at 1 site in United Kingdom.
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 16 inclusion and 22 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 9 Nov 2023. 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 United Kingdom. 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.
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?
The take rate of parasitologically confirmed cutaneous leishmaniasis lesions in study subjects (time frame: 1 year). 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 NCT04512742, which also lists 2 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 9 Nov 2023.