Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396

NCT00657917 | Terminated Phase 2 Results

• 1 other identifier: A-13225
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this protocol is to treat laboratory confirmed cutaneous leishmaniasis with WR 279,396 in military health care beneficiaries. In this study "cutaneous leishmaniasis" is defined as Old World Leishmaniasis if acquired in the Southwest Central Asia/Middle East.

Conditions

Cutaneous Leishmaniasis

Keywords

leishmaniasis; cutaneous; Old World; Leishmania major; Treatment

Outcome Measures

Primary Outcomes (1)

• The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse

  Appearance of complete (100%) epithelialization of a skin lesion at day 50+2 weeks, or the estimated 50%-99% re-epithelialization by day 50+2 weeks followed by complete eipithelialization by day 100+2 weeks, with both categories without relapse by day 180+30 days. Ulcer measured in millimeters.

  180 days

Secondary Outcomes (2)

• Number of Relapses

  180 days

• Safety and Tolerability (SAE's and AE's)

  180 days

Study Arms (1)

Paromomycin +Gentamicin topical cream

EXPERIMENTAL

WR279,396 topically twice a day for 20 days

Drug: Paromomycin +Gentamicin topical cream

Interventions

Paromomycin +Gentamicin topical cream DRUG

WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.

Also known as: WR279,396

Paromomycin +Gentamicin topical cream

Eligibility Criteria

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

You may qualify if:

• Parasitologically confirmed, primarily ulcerative, Old World CL, in a patient who had either failed pentavalent antimony treatment, or who was ineligible for pentavalent antimony therapy.
• Military health care beneficiary 18 years of age or greater, unless active military in which case, 17 years is the minimum age
• Proven parasitological diagnosis by culture, PCR or microscopy in at least one skin lesion
• Lesions primarily ulcerative (i.e., not verrucous or nodular)
• Written informed consent to participate in protocol
• Negative pregnancy test within 72 hours of starting protocol
• Agrees to take precautions not to become pregnant or father a child for at least two months after completion of treatment with WR 279,396
• Cutaneous leishmaniasis acquired in Southwest Central Asia/Middle East\*
• Inadequate response to treatment with pentavalent antimony or medical condition that precludes the use of pentavalent antimony

You may not qualify if:

• Drug intolerance: history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides in the patient
• any leishmanial lesion on mucosal surface
• Presence of signs or symptoms of peripheral neuropathic myasthenia gravis, neuromuscular block
• Routinely taking nephrotoxic or ototoxic medications
• Disseminated disease defined as clinically significant subcutaneous nodules that are in the lymphatic drainage tract for the skin lesion with regional adenopathy \> 1 cm
• Abnormal Romberg test at baseline
• Clinically significant medical problems of the kidney or liver as determined by history and by the following laboratory studies:
• Kidney: Creatinine \> 2x the upper limit of normal
• Liver: ASTor ALT \>4x the upper limit fo normal
• This includes "L. major," "L. tropica," and "L. infantum" with over 98% of cases in U.S. military in 2002-2004 being "L. major"
• An inadequate response to treatment with pentavalent antimony includes patients who show no or little improvement during a 15-20 day treatment course, those that initially epithelialize but later show signs of breakdown/ ulceration or develop new lesions. In general, for those with initial treatment response, would recommend waiting for approximately two months after pentavalent antimony and if lesion is not epithelialized at that time, consideration for further therapy is advised.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Walter Reed Army Medical Center: collaborator

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Leishmaniasis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination due to only 1 patient enrolled.

Results Point of Contact

• Title: COL Naomi Aronson MC
• Organization: Uniformed Services University of the Heralth Sciences

naronson@usuhs.mil

301-295-3621

Study Officials

• COL Naomi Aronson, M.D.

  Uniformed Services Univ of the Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: April 14, 2008
• Study Start: December 20, 2006
• Primary Completion: June 8, 2007
• Study Completion: June 24, 2010
• Last Updated: January 22, 2019
• Results First Posted: January 22, 2019

Record last verified: 2018-08

Locations

US (1)