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Expanded Access WR 279396 Topical Cream Treatment for Uncomplicated Cutaneous Leishmaniasis

Information source: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leishmaniasis, Cutaneous

Intervention: WR 279,396 (Drug)

Phase: N/A

Status: Available

Sponsored by: U.S. Army Medical Research and Materiel Command

Official(s) and/or principal investigator(s):
Naomi Aronson, MD, Principal Investigator, Affiliation: Uniformed Services University of the Health Sciences

Overall contact:
Naomi Aronson, MD, Phone: 301-295-3621, Email: naomi.aronson@usuhs.edu

Summary

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.

Clinical Details

Official title: WR 279,396 (Paromomycin + Gentamicin Topical Cream) Treatment Protocol for Individuals With Uncomplicated Cutaneous Leishmaniasis

Study design: N/A

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

Minimum age: N/A. Maximum age: N/A. Gender(s): 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

Locations and Contacts

Naomi Aronson, MD, Phone: 301-295-3621, Email: naomi.aronson@usuhs.edu

Walter Reed National Military Medical Center, Bethesda, Maryland 20814, United States
Naomi Aronson, MD, Phone: 301-295-3621, Email: naomi.aronson@usuhs.edu
Peter J Weina, MD, Phone: 301-400-1239, Email: peter.j.weina.mil@mail.mil

Military Treatment Facilities, Multiple, Maryland 20814, United States
Naomi Aronson, MD, Email: usarmy.detrick.medcom-usammda.list.leishmania-tx-protocol@mail.mil
Naomi Aronson, MD, Principal Investigator

Additional Information

Related publications:

Grogl M, Schuster BG, Ellis WY, Berman JD. Successful topical treatment of murine cutaneous leishmaniasis with a combination of paromomycin (Aminosidine) and gentamicin. J Parasitol. 1999 Apr;85(2):354-9.


Last updated: July 8, 2015

Page last updated: August 23, 2015

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