Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients

• ClinicalTrials.gov Identifier: NCT02281669
• Recruitment Status: Unknown
• First Posted: November 3, 2014
• Last Update Posted: November 3, 2014
• Sponsor: Sheba Medical Center
• Information provided by (Responsible Party): Prof. Eli Schwartz MD, DTMH, Sheba Medical Center

Tracking Information

• First Submitted Date: October 30, 2014
• First Posted Date: November 3, 2014
• Last Update Posted Date: November 3, 2014
• Study Start Date: November 2014
• Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 30, 2014)

Adverse effects [ Time Frame: 1 year ]

The adverse effects of IL Pentostam treatment will be monitored during the follow up period.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 30, 2014)

Lesion healing [ Time Frame: 1 year ]

Lesions number and size will be recorded and response to treatment will be monitored.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients
• Official Title: Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients
• Brief Summary: Cutaneous leishmaniasis (CL) is endemic in Israel and is caused by Leishmania major or Leishmania tropica. CL is usually a benign disease and limited to the skin. One of the local treatment available is intralesional (IL) Pentostam injection. During the current study the investigators will monitor the adverse effects of this treatment and will follow up the recovery of the lesions after Pentostam injections.

Detailed Description

Cutaneous leishmaniasis is usually treated by topical intervention. In more severe cases intralesional Pentostam injection may be applied. This treatment is extremely efficient but painful, however without the known adverse effects of IV Pentostam treatment.

In this study the investigators will follow systematically all leishmania patients who are receiving the intralesional treatment. A structured questionnaire will be filled up in each doctor visit.

The current study goal is to examine the adverse effects and the patient reaction to this treatment, and to follow the recovery of lesion(s) after this treatment including the number of IL injections which was needed.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients arriving to the Geographic clinic or to the Skin clinic, diagnosed with Cutaneous leishmaniasis, and the treatment which is choosen by their physican is Pentostam injections.
• Condition: Cutaneous Leishmaniasis

Intervention

Drug: Pentostam

Intralesional injection of Pentostam

Other Name: Pentavalent antimonials

Study Groups/Cohorts

Research group

The study group includes all CL cases for whom the treating physician decides to treat by IL Pentostam. The patients will return to follow up and additional treatment every 3 weeks until full recovery [as our current policy].

Intervention: Drug: Pentostam

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 30, 2014): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2017
• Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Cutaneous leishmaniasis patients
• Treatment by IL Pentostam
• Age above 18 years

Exclusion Criteria:

• Children and pregnant women will not participate in the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT02281669
• Other Study ID Numbers: SHEBA-14-1571-ES-CTIL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Prof. Eli Schwartz MD, DTMH, Sheba Medical Center
• Study Sponsor: Sheba Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Eli Schwartz, M.D, DTMH; Sheba Medical Center

• PRS Account: Sheba Medical Center
• Verification Date: October 2014