Back to resultsWR 279,396 Open Label Treatment Protocol in Tunisia
Primary Purpose
Cutaneous Leishmaniasis
Status
Terminated
Phase
Phase 2
Locations
Tunisia
Study Type
Interventional
Intervention
WR 279,396 topical cream
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Leishmaniasis focused on measuring cutaneous leishmaniasis, topical treatment, Tunisia
Eligibility 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.
Sites / Locations
- Central Clinic-Sidi Bouzid
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WR 279,396 topical cream
Arm Description
120 subjects will be enrolled to this open label study to receive WR 279,396 topical cream
Outcomes
Primary Outcome Measures
Final Clinical Cure Rate for the Index Lesion
Number of index lesions with 100% reepithelialization at Day 98.
Secondary Outcome Measures
Area of Index Lesions Throughout the Study
Area (mm^2) of index lesion on Days 0, 20, 28, 42, and 98.
Number of Index Lesions With Reepithelialization Throughout the Study
Number of index lesions with 100% reepithelialization on Days 28 and 42.
Area of All Ulcerated Lesions Throughout the Study
Area of all ulcerated lesions on Days 20, 28, 42, and 98.
Number of All Ulcerated Lesions With Reepithelialization on Day 28
Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28
Full Information
NCT ID
NCT01494350
First Posted
November 30, 2011
Last Updated
December 18, 2014
Sponsor
U.S. Army Medical Research and Development Command
Collaborators
Walter Reed Army Institute of Research (WRAIR)
1. Study Identification
Unique Protocol Identification Number
NCT01494350
Brief Title
WR 279,396 Open Label Treatment Protocol in Tunisia
Official Title
Open-label Treatment of Non-complicated, Non-severe, Cutaneous Leishmaniasis in Tunisia With WR 279,396 (Paromomycin + Gentamicin Topical Cream) )
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
This study was closed prematurely due study team travel restrictions.
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
Collaborators
Walter Reed Army Institute of Research (WRAIR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Subjects will have an in-clinic follow-up on Days 28 +/- 2 days, 42 +/- 4 days and 98 +/- 8 days to assess safety and cure rates. Safety variables including adverse events (AEs) and serious adverse events (SAEs) will be collected through Day 98. For the primary efficacy evaluation, the index ulcerative lesion will be assessed for clinical response by measurement of the length and width of area of ulceration. All other treated lesions will also be assessed for cure as secondary efficacy endpoints with ulcerated and non-ulcerated lesions being evaluated independently. An ulcerated lesion will be considered to be completely cured if 100% reepithelialization is observed. The length and width of non-ulcerated lesions (nodules, plaques) will also be measured and evaluated for cure (ie, absence of signs of an active lesion). The primary efficacy endpoint is the final clinical cure rate calculated by the number of index lesions that had 100% reepithelialization at Day 98 divided by the total number of index lesions that received at least one topical treatment of WR 279,396.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Leishmaniasis
Keywords
cutaneous leishmaniasis, topical treatment, Tunisia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WR 279,396 topical cream
Arm Type
Experimental
Arm Description
120 subjects will be enrolled to this open label study to receive WR 279,396 topical cream
Intervention Type
Drug
Intervention Name(s)
WR 279,396 topical cream
Other Intervention Name(s)
WR 279, 396, Topical Paromomycin + Gentamicin Cream
Intervention Description
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.
Primary Outcome Measure Information:
Title
Final Clinical Cure Rate for the Index Lesion
Description
Number of index lesions with 100% reepithelialization at Day 98.
Time Frame
Final clincial cure is measured at day 98
Secondary Outcome Measure Information:
Title
Area of Index Lesions Throughout the Study
Description
Area (mm^2) of index lesion on Days 0, 20, 28, 42, and 98.
Time Frame
Measured at day 0, 20, 28, 42, and 98
Title
Number of Index Lesions With Reepithelialization Throughout the Study
Description
Number of index lesions with 100% reepithelialization on Days 28 and 42.
Time Frame
Measured at day 28 and 42
Title
Area of All Ulcerated Lesions Throughout the Study
Description
Area of all ulcerated lesions on Days 20, 28, 42, and 98.
Time Frame
Measured at day 20, 28, 42 and 98
Title
Number of All Ulcerated Lesions With Reepithelialization on Day 28
Description
Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28
Time Frame
Measured on day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afif Ben Salah, M.D., Ph.D.
Organizational Affiliation
Institute Pasteur Tunisia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Clinic-Sidi Bouzid
City
Tunis
Country
Tunisia
12. IPD Sharing Statement
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WR 279,396 Open Label Treatment Protocol in Tunisia
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