WR 279,396 Open Label Treatment Protocol in Tunisia

This study has been terminated.
(This study was closed prematurely due study team travel restrictions.)
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01494350
First received: November 30, 2011
Last updated: December 18, 2014
Last verified: December 2014
Results First Received: December 9, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cutaneous Leishmaniasis
Intervention: Drug: WR 279,396 topical cream

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
184 total screened and there were 134 screen failures.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
WR 279,396 Topical Cream 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.

Participant Flow:   Overall Study
    WR 279,396 Topical Cream  
STARTED     50  
COMPLETED     49  
NOT COMPLETED     1  
Worsening of lesion                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
modified intent to treat (mITT)/safety subjects

Reporting Groups
  Description
WR 279,396 Topical Cream 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.

Baseline Measures
    WR 279,396 Topical Cream  
Number of Participants  
[units: participants]
  50  
Age  
[units: years]
Mean (Standard Deviation)
  38.7  (13.1)  
Gender  
[units: participants]
 
Female     30  
Male     20  
Race/Ethnicity, Customized  
[units: participants]
 
North African     50  
Number of lesions per subject  
[units: lesions]
Mean (Standard Deviation)
  1.96  (1.48)  



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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Afif Ben Salah, MD, PhD
Organization: Institut Pasteur of Tunis
phone: 011-216-71-792-429
e-mail: afif.bensalah@pasteur.rns.tn


No publications provided


Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01494350     History of Changes
Other Study ID Numbers: S-10-0006; A-16898.3
Study First Received: November 30, 2011
Results First Received: December 9, 2014
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration