Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

NCT01769612 | Completed Results

• 3 other identifiers: S-12-14A-15174.2bK141341
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.

Conditions

Skin Diseases, Parasitic

Keywords

Leishmaniasis, Leishmania

Outcome Measures

Primary Outcomes (1)

• 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.

  within 1 hour after taking samples

Study Arms (1)

CL Detect Rapid Test and Microsopy Samples

Samples taken to be evaluated in the CL Detect and Microscopy assays

Other: No Intervention

Interventions

No Intervention OTHER

CL Detect Rapid Test and Microsopy Samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• Received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• InBios International, Inc.: collaborator
• Institut Pasteur of Tunis, Tunisia: collaborator

Study Sites (2)

Primary Health Clinic

Gafsa, Gafsa Governorate, Tunisia

Location

Primary Health Clinics

Sidi Bouzid, Sidi Bouzid Governorate, Tunisia

Location

MeSH Terms

Conditions

Skin Diseases, Parasitic; Leishmaniasis

Condition Hierarchy (Ancestors)

Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Euglenozoa Infections; Protozoan Infections; Vector Borne Diseases

Results Point of Contact

• Title: Afif Gen Salah, MD, PhD
• Organization: Institut Pasteur of Tunis

noemailavailable@no.com

011-216-71-792-429

Study Officials

• Afif Ben Salah, MD PhD

  Institut Pasteur de Tunis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 16, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: April 1, 2014
• Last Updated: June 20, 2017
• Results First Posted: June 20, 2017

Record last verified: 2017-04

Locations

TU (2)