- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01494350
WR 279,396 Open Label Treatment Protocol in Tunisia
December 18, 2014 updated by: U.S. Army Medical Research and Development Command
Open-label Treatment of Non-complicated, Non-severe, Cutaneous Leishmaniasis in Tunisia With WR 279,396 (Paromomycin + Gentamicin Topical Cream) )
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tunis, Tunisia
- Central Clinic-Sidi Bouzid
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WR 279,396 topical cream
120 subjects will be enrolled to this open label study to receive WR 279,396 topical cream
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Final Clinical Cure Rate for the Index Lesion
Time Frame: Final clincial cure is measured at day 98
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Number of index lesions with 100% reepithelialization at Day 98.
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Final clincial cure is measured at day 98
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area of Index Lesions Throughout the Study
Time Frame: Measured at day 0, 20, 28, 42, and 98
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Area (mm^2) of index lesion on Days 0, 20, 28, 42, and 98.
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Measured at day 0, 20, 28, 42, and 98
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Number of Index Lesions With Reepithelialization Throughout the Study
Time Frame: Measured at day 28 and 42
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Number of index lesions with 100% reepithelialization on Days 28 and 42.
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Measured at day 28 and 42
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Area of All Ulcerated Lesions Throughout the Study
Time Frame: Measured at day 20, 28, 42 and 98
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Area of all ulcerated lesions on Days 20, 28, 42, and 98.
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Measured at day 20, 28, 42 and 98
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Number of All Ulcerated Lesions With Reepithelialization on Day 28
Time Frame: Measured on day 28
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Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28
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Measured on day 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Afif Ben Salah, M.D., Ph.D., Institute Pasteur Tunisia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
November 30, 2011
First Submitted That Met QC Criteria
December 15, 2011
First Posted (Estimate)
December 19, 2011
Study Record Updates
Last Update Posted (Estimate)
December 19, 2014
Last Update Submitted That Met QC Criteria
December 18, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Euglenozoa Infections
- Leishmaniasis
- Leishmaniasis, Cutaneous
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Gentamicins
- Paromomycin
Other Study ID Numbers
- S-10-0006; A-16898.3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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