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

NCT02281669 | Unknown

• 1 other identifier: SHEBA-14-1571-ES-CTIL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Leishmaniasis

Outcome Measures

Primary Outcomes (1)

• Adverse effects

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

  1 year

Secondary Outcomes (1)

• Lesion healing

  1 year

Study Arms (1)

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

Interventions

Pentostam DRUG

Intralesional injection of Pentostam

Also known as: Pentavalent antimonials

Research group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Children and pregnant women will not participate in the study

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Center of Geographic Medicine

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Antimony Sodium Gluconate

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Eli Schwartz, M.D, DTMH

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eli Schwartz, M.D, DTMH

CONTACT

+97235308456; Eli.schwartz@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator of the geographic clinic, Sheba medical center

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 3, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: November 3, 2014

Record last verified: 2014-10

Locations

IL (1)