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

NCT ID: NCT00657917

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-20
• Study Completion Date: 2010-06-24

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.

Detailed Description

Up to 10 volunteers, who are military health care beneficiaries, with a diagnosis of Old World cutaneous leishmaniasis who have failed pentavalent antimony or are not eligible to be treated with pentavalent antimony, will be treated with WR 279,396 (topical paromomycin-gentamicin-AQIC) twice a day for 20 days. Primary endpoint will be the appearance of complete epithelialization of each skin lesion by Day 50+/-2 weeks, or estimated 50%-99% re-epithelialization by Day 50+/-2 weeks followed by complete epithelialization by Day 100+/-2 weeks,with both categories without relapse by Day 180+/-30 days. Efficacy will be evaluated by clinical appearance assessed by study investigator and documented with photographs of the treated skin lesions. Toxicity will be evaluated by local adverse reactions and by laboratory signs of systemic toxicity.

Conditions

Cutaneous Leishmaniasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paromomycin +Gentamicin topical cream

WR279,396 topically twice a day for 20 days

Group Type: EXPERIMENTAL

Paromomycin +Gentamicin topical cream

Intervention Type: 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.

Interventions

Paromomycin +Gentamicin topical cream

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.

Intervention Type: DRUG

Other Intervention Names

WR279,396

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

COL Naomi Aronson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services Univ of the Health Sciences

Locations

Walter Reed Army Medical Center

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

Countries

United States

Other Identifiers

A-13225

Identifier Type: -

Identifier Source: org_study_id