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 2, 2014
Last Update Posted : November 2, 2014
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Tracking Information | ||||
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First Submitted Date | October 30, 2014 | |||
First Posted Date | November 2, 2014 | |||
Last Update Posted Date | November 2, 2014 | |||
Study Start Date | November 2014 | |||
Estimated Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Adverse effects [ Time Frame: 1 year ] The adverse effects of IL Pentostam treatment will be monitored during the follow up period.
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Original Primary Outcome Measures | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures |
Lesion healing [ Time Frame: 1 year ] Lesions number and size will be recorded and response to treatment will be monitored.
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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. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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
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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
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Sheba Medical Center | |||
Verification Date | October 2014 |