Expanded Access WR 279396 Topical Cream Treatment for Uncomplicated Cutaneous Leishmaniasis (WR279396RX)

Expanded access is currently available for this treatment.
Verified May 2014 by U.S. Army Medical Research and Materiel Command
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01641796
First received: June 18, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

This is an expanded access treatment protocol designed to provide a topical cream treatment option to military health care beneficiaries with parasitologically confirmed uncomplicated Cutaneous Leishmaniasis.


Condition Intervention
Leishmaniasis, Cutaneous
Drug: WR 279,396

Study Type: Expanded Access     What is Expanded Access?
Official Title: WR 279,396 (Paromomycin + Gentamicin Topical Cream) Treatment Program for Individuals With Uncomplicated Cutaneous Leishmaniasis

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Intervention Details:
    Drug: WR 279,396
    Topical Cream applied to lesion once a day
    Other Name: Topical paromomycin and gentamicin combination cream.
Detailed Description:

When a military health care beneficiary presents at a Department of Defense Military Treatment Facility with a skin lesion clinically and epidemiologically consistent with suspicious Cutaneous Leishmaniasis, routine diagnostic parasitology testing will be performed as standard of care, and if there is a positive diagnosis, the patient will be offered the option to participate in this treatment program and after providing written informed consent/assent., if eligible to participate, the patient will receive treatment with WR 279,396.

  Eligibility

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Male or female military health care beneficiary of any age.
  • Diagnosis of uncomplicated CL by having at least one lesion parasitologically confirmed by at least one of the following methods: 1) positive culture for promastigotes; 2) microscopic identification of amastigotes in stained lesion tissue; and/or 3) PCR assay performed either at the LDL, WRAIR or the Clinical Parasitology Service, CDC.
  • Ability to comprehend and willingness to sign informed consent or give assent
  • CL lesions in a location amenable to topical treatment
  • Patient is willing to forgo other treatments for CL while on treatment program
  • Females of childbearing potential must have a negative pregnancy test within 1 day of starting treatment and agree to use an acceptable method of birth control from start of treatment until 2 weeks after completing treatment

Exclusion Criteria:

  • Clinically significant concomitant disease that would preclude the patient from completing treatment in the opinion of the treating physician.
  • Clinical Evidence of mucosal involvement
  • Known allergy to aminoglycosides
  • Females who are pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641796

Contacts
Contact: Naomi Aronson, MD 301-295-3621 naomi.aronson@usuhs.edu
Contact: Timothy Whitman, DO 301-295-6400 timothy.whitman@med.navy.mil

Locations
United States, Maryland
Military Treatment Facilities
Multiple, Maryland, United States
Contact: Naomi Aronson, MD       usarmy.detrick.medcom-usammda.list.leishmania-tx-protocol@mail.mil   
Principal Investigator: Naomi Aronson, MD         
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Naomi Aronson, MD Uniformed Services University of the Health Sciences
  More Information

Publications:
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01641796     History of Changes
Other Study ID Numbers: S-12-13, S-12-13
Study First Received: June 18, 2012
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Cutaneous Leishmaniasis
CL
Lesion
Topical
Treatment
Cream
Expanded Access

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Gentamicins
Paromomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Amebicides
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 28, 2014