WR 279,396 Open Label Treatment Protocol in Tunisia

NCT01494350 | Terminated Phase 2 Results

• 1 other identifier: S-10-0006; A-16898.3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The U.S. Army has recently completed a Phase 3 clinical trial in Tunisia. This is an open-label single site trial designed to expand our safety database and capture additional efficacy (final clinical cure rate of an index lesion) of WR 279,396 Topical Cream in Tunisian subjects with non-complicated, non-severe Cutaneous Leishmaniasis (CL). Subjects will be patients who visit Ministry of Health sponsored clinics in Tunisia who present with at least one CL lesion that is ulcerated and amenable to topical treatment. Potential trial subjects will be consented and screened for eligibility including medical history, physical exam, lesion parasitology, and renal and liver function tests. If eligible for the study, subjects will receive WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) (target n = 110). The cream will be applied topically to all CL lesions once daily for 20 days by an investigator or study nurse. If a subject develops a new lesion during the study, the new lesion may also be treated with the topical cream.

Conditions

Cutaneous Leishmaniasis

Keywords

cutaneous leishmaniasis; topical treatment; Tunisia

Outcome Measures

Primary Outcomes (1)

• Final Clinical Cure Rate for the Index Lesion

  Number of index lesions with 100% reepithelialization at Day 98.

  Final clincial cure is measured at day 98

Secondary Outcomes (4)

• Area of Index Lesions Throughout the Study

  Measured at day 0, 20, 28, 42, and 98

• Number of Index Lesions With Reepithelialization Throughout the Study

  Measured at day 28 and 42

• Area of All Ulcerated Lesions Throughout the Study

  Measured at day 20, 28, 42 and 98

• Number of All Ulcerated Lesions With Reepithelialization on Day 28

  Measured on day 28

Study Arms (1)

WR 279,396 topical cream

EXPERIMENTAL

120 subjects will be enrolled to this open label study to receive WR 279,396 topical cream

Drug: WR 279,396 topical cream

Interventions

WR 279,396 topical cream DRUG

WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.

Also known as: WR 279, 396, Topical Paromomycin + Gentamicin Cream

WR 279,396 topical cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (1)

Central Clinic-Sidi Bouzid

Tunis, Tunisia

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Paromomycin

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Limitations and Caveats

This study was closed prematurely due study team and travel restrictions but not due to any safety issues with the study subjects. Only a total of 50 of the 110 planned subjects were enrolled in the study.

Results Point of Contact

• Title: Afif Ben Salah, MD, PhD
• Organization: Institut Pasteur of Tunis

afif.bensalah@pasteur.rns.tn

011-216-71-792-429

Study Officials

• Afif Ben Salah, M.D., Ph.D.

  Institute Pasteur Tunisia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 19, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-12

Locations

TU (1)