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Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00884377
First received: April 17, 2009
Last updated: June 15, 2017
Last verified: June 2017
Results First Received: February 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Cutaneous Leishmaniasis
Interventions: Drug: Sodium stibogluconate (Pentostam)
Device: ThermoMed

  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
Fifty Six subjects were recruited from the Infectious Disease Clinic at Walter Reed Army Medical Center from February 2004 to March 2009. At 2 months post-treatment, subjects assessed as having failed therapy were eligible for crossover to an alternate treatment.

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
Treatment With IV Sodium Stibogluconate Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic.
Treatment With Thermomed Device Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated

Participant Flow:   Overall Study
    Treatment With IV Sodium Stibogluconate   Treatment With Thermomed Device
STARTED   28 [1]   28 [2] 
COMPLETED   26 [3]   27 
NOT COMPLETED   2   1 
Withdrawal by Subject                1                0 
Could not confirm diagnosis                1                0 
Physician Decision                0                1 
[1] 1 not treated because infecting parasite could not be confirmed as L. major on rapid PCR testing,
[2] 1 was not treated due to concerns arising from the location of cutaneous leishmaniasis lesion
[3] 1 received full course of therapy,withdrew consent before completion of the 12 month follow up



  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.
No text entered.

Reporting Groups
  Description
Treatment With IV Sodium Stibogluconate Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic.
Treatment With Thermomed Device Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated
Total Total of all reporting groups

Baseline Measures
   Treatment With IV Sodium Stibogluconate   Treatment With Thermomed Device   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   28   56 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      28 100.0%      28 100.0%      56 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.0  (9.7)   28.9  (8.3)   27.9  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1   3.6%      0   0.0%      1   1.8% 
Male      27  96.4%      28 100.0%      55  98.2% 
Region of Enrollment 
[Units: Participants]
     
United States   28   28   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure   [ Time Frame: Assessment of cure is made at 2 months after treatment ]

2.  Secondary:   Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure   [ Time Frame: 12 months ]

3.  Secondary:   Number of Participants With Solicited Adverse Events   [ Time Frame: Days 3, 7 and 10 ]

4.  Secondary:   Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments   [ Time Frame: day 1 and day 10 ]

5.  Secondary:   Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments   [ Time Frame: day 1 and day 10 ]

6.  Secondary:   Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial   [ Time Frame: at baseline before treatment ]


  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
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  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: Dr. Naomi Aronson, Principal Investigator
Organization: Walter Reed Army Medical Center
phone: 202-782-8691
e-mail: naronson@usuhs.mil


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00884377     History of Changes
Other Study ID Numbers: A-12364
Study First Received: April 17, 2009
Results First Received: February 13, 2017
Last Updated: June 15, 2017