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

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ClinicalTrials.gov Identifier: NCT02281669
Recruitment Status : Unknown
Verified October 2014 by Prof. Eli Schwartz MD, DTMH, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 3, 2014
Last Update Posted : November 3, 2014
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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