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
|Condition or disease||Intervention/treatment|
|Cutaneous Leishmaniasis||Drug: Pentostam|
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|
|Estimated Enrollment :||100 participants|
|Official Title:||Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||January 2017|
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].
Intralesional injection of Pentostam
Other Name: Pentavalent antimonials
- Adverse effects [ Time Frame: 1 year ]The adverse effects of IL Pentostam treatment will be monitored during the follow up period.
- Lesion healing [ Time Frame: 1 year ]Lesions number and size will be recorded and response to treatment will be monitored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281669
|Contact: Eli Schwartz, M.D, DTMH||+97235308456||Eli.email@example.com|
|Center of Geographic Medicine|
|Tel Hashomer, Israel|
|Principal Investigator:||Eli Schwartz, M.D, DTMH||Sheba Medical Center|