Status:
TERMINATED
Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
Walter Reed Army Medical Center
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 define...
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 penta...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00657917
Start Date
December 20 2006
End Date
June 24 2010
Last Update
January 22 2019
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307