Overview
Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396
Status:
Terminated
Terminated
Trial end date:
2010-06-24
2010-06-24
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
U.S. Army Medical Research and Development Command
U.S. Army Medical Research and Materiel CommandCollaborator:
Walter Reed Army Medical CenterTreatments:
Gentamicins
Paromomycin
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.