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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Prof. Eli Schwartz MD, DTMH, Sheba Medical Center

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.

Condition or disease Intervention/treatment
Cutaneous Leishmaniasis Drug: Pentostam

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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Group/Cohort Intervention/treatment
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].
Drug: Pentostam
Intralesional injection of Pentostam
Other Name: Pentavalent antimonials




Primary Outcome Measures :
  1. Adverse effects [ Time Frame: 1 year ]
    The adverse effects of IL Pentostam treatment will be monitored during the follow up period.


Secondary Outcome Measures :
  1. Lesion healing [ Time Frame: 1 year ]
    Lesions number and size will be recorded and response to treatment will be monitored.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Eli Schwartz, M.D, DTMH +97235308456 Eli.schwartz@sheba.health.gov.il

Locations
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Israel
Center of Geographic Medicine
Tel Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Eli Schwartz, M.D, DTMH Sheba Medical Center
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Responsible Party: Prof. Eli Schwartz MD, DTMH, Principal investigator of the geographic clinic, Sheba medical center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02281669    
Other Study ID Numbers: SHEBA-14-1571-ES-CTIL
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: November 2, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antimony Sodium Gluconate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics