Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396 (NCT00657917) | Clinical Trial Compass
TerminatedPhase 2
Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396
Stopped: No subjects were enrolled since the first subject completed the study 08Jun2007
United States1 participantsStarted 2006-12-20
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 a…
What they're measuring
1
The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse
Timeframe: 180 days
Trial details
NCT IDNCT00657917
SponsorU.S. Army Medical Research and Development Command