Skin Diseases, ParasiticCL Detect™NCT01769612
Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
An observational study of Skin Diseases, Parasitic, run by U.S. Army Medical Research and Development Command at 2 sites in Tunisia.
Trial summary
The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Diseases, Parasitic
- How many people
- 168 participants
- Where
- 2 sitesTunisia
- Study dates
- Jan 2013to Apr 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- At least 18 years of age and generally healthy
- Subject able to give written informed consent
- Subject has a lesion suspicious for leishmaniasis that satisfies the following criteria for an index lesion:
- less than 4 months in age
- primarily ulcerative, ie not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis
- in a location suitable for collecting samples by dental broach, scraping, and aspiration
- In the opinion of the investigator, the subject is capable of understanding and complying with the protocol
Who cannot join
- Received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Primary Health Clinic
Gafsa, Gafsa Governorate
Primary Health Clinics
Sidi Bouzid, Sidi Bouzid Governorate
About this study
Official title: Evaluation of a Diagnostic Device, CL Detect Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.
Read the detailed description
Subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (CL). Study compared the CL Detect Rapid Test vs microscopic identification of Leishmania amastigotes in a stained lesion sample. Two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the CL Detect Rapid Test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. Samples were analyzed by microscopy and CL Detect Repaid Test by different operators who evaluated each sample independently blinded to the other assay result.
- Conditions
- Skin Diseases, Parasitic
- Being tested
- No Intervention
- Keywords
- Leishmaniasis, Leishmania
- Medical subject headings
- Skin Diseases, Parasitic, Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| CL Detect Rapid Test and Microsopy Samples | Samples taken to be evaluated in the CL Detect and Microscopy assays Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results
Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results.
Note: only data where results for all three methods were available were included in the analysis.
Measured: within 1 hour after taking samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin Diseases, ParasiticStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- InBios International, Inc., Institut Pasteur of Tunis, Tunisia
- Responsible party
- Sponsor
- Investigators
- Afif Ben Salah, MD PhD, Principal investigator, Institut Pasteur de Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769612
- Sponsor's protocol ID
- S-12-14
- Other IDs
- A-15174.2b, K141341
- Acronym
- CL Detect™
- Status last verified
- Apr 2017
- First submitted
- 14 Jan 2013
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Diagnostic Device, CL Detect Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
- ClinicalTrials.gov ID
- NCT01769612
- Acronym / sponsor ID
- CL Detect™ / S-12-14
- Conditions
- Skin Diseases, Parasitic
- Keywords
- Leishmaniasis, Leishmania
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- InBios International, Inc., Institut Pasteur of Tunis, Tunisia
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Posted 20 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.
Detailed description
Subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (CL). Study compared the CL Detect Rapid Test vs microscopic identification of Leishmania amastigotes in a stained lesion sample. Two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the CL Detect Rapid Test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. Samples were analyzed by microscopy and CL Detect Repaid Test by different operators who evaluated each sample independently blinded to the other assay result.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CL Detect Rapid Test and Microsopy Samples | – | Other: No InterventionSamples taken to be evaluated in the CL Detect and Microscopy assays |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (7 listed)
- At least 18 years of age and generally healthy
- Subject able to give written informed consent
- Subject has a lesion suspicious for leishmaniasis that satisfies the following criteria for an index lesion:
- In the opinion of the investigator, the subject is capable of understanding and complying with the protocol
Key exclusion criteria (1 listed)
- Received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome
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 |
|---|---|---|
| No Intervention | Other | CL Detect Rapid Test and Microsopy Samples |
Primary outcome
Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results
Time frame: within 1 hour after taking samples
Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results. Note: only data where results for all three methods were available were included in the analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Skin Diseases, Parasitic
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Diagnosis and Treatment of Leishmania Infections
Kinetoplastid, Skin Diseases, Parasitic
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.
Afif Ben Salah, MD PhD principal investigator
Institut Pasteur de Tunis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Diseases, Parasitic, run by U.S. Army Medical Research and Development Command at 2 sites in Tunisia.
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 7 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results (time frame: within 1 hour after taking samples). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.