WR 279,396 Open Label Treatment Protocol in Tunisia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01494350
• Date of registration: 30/11/2011
• Prospective Registration: Yes
• Primary sponsor: U.S. Army Medical Research and Materiel Command
• Public title: WR 279,396 Open Label Treatment Protocol in Tunisia
• Scientific title: Open-label Treatment of Non-complicated, Non-severe, Cutaneous Leishmaniasis in Tunisia With WR 279,396 (Paromomycin + Gentamicin Topical Cream) )
• Date of first enrolment: December 2011
• Target sample size: 50
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01494350
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Tunisia

Contacts

• Name: Afif Ben Salah, M.D., Ph.D.
• Affiliation: Institute Pasteur Tunisia

Key inclusion & exclusion criteria

Inclusion Criteria:

- At least 18 years of age

- Subject has a diagnosis of CL in at least one lesion by at least one of the following
methods: 1) microscopic identification of amastigotes in stained lesion tissue, or 2)
positive culture for promastigotes.

- Subject has a parasitologically confirmed lesion that satisfies the following criteria
for an Index lesion:

- ulcerative in character

- lesion size = 1 cm and =5 cm (including the area of induration surrounding the
lesion)

- not located on the ear, or on a location that in the opinion of the PI is
difficult to maintain application of study drug topically.

- Subject has < 7 leishmaniasis total lesions.

- Subject is willing to forego other forms of treatments for CL including other
investigational treatments during the study.

- In the opinion of the investigator, the subject (or their legal guardian) is capable
of understanding and complying with the protocol.

Exclusion Criteria:

- Female with a positive serum pregnancy test or who is breast feeding.

- History of clinically significant medical problems in the investigator's judgment that
might interact, either negatively or positively, with topical treatment of
leishmaniasis including any immunocompromising condition.

- Age adjusted blood creatinine or blood urea nitrogen (BUN) levels indicative of
clinically significant renal disease or aspartate amino transferase (AST), alanine
amino transferase (ALT), or total bilirubin that suggest clinically significant
hepatic impairment as judged by the PI or subinvestigator. Note: This study is
designed to evaluate populations who may have some renal or hepatic dysfunction as the
drug has not been shown to have serum levels that would be expected to show renal or
hepatic toxicity and treatment of the general population presenting with CL is highly
desired based on its safety profile compared to other leishmanial drugs.

- Evidence of disseminated leishmaniasis.

- Received treatment for leishmaniasis with antimonials or any medication likely, in the
opinion of the PI, to modify the course of the Leishmania infection within 56 days of
starting study treatments.

- History of known or suspected hypersensitivity or idiosyncratic reactions to
aminoglycosides.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cutaneous Leishmaniasis

Intervention(s)

Drug: WR 279,396 topical cream

Primary Outcome(s)

Final Clinical Cure Rate for the Index Lesion [Time Frame: Final clincial cure is measured at day 98]

Secondary Outcome(s)

Number of Index Lesions With Reepithelialization Throughout the Study [Time Frame: Measured at day 28 and 42]

Number of All Ulcerated Lesions With Reepithelialization on Day 28 [Time Frame: Measured on day 28]

Area of All Ulcerated Lesions Throughout the Study [Time Frame: Measured at day 20, 28, 42 and 98]

Area of Index Lesions Throughout the Study [Time Frame: Measured at day 0, 20, 28, 42, and 98]

Secondary ID(s)

S-10-0006; A-16898.3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Walter Reed Army Institute of Research (WRAIR)

Results

• Results available: Yes
• Date Posted: 19/12/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01494350