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

Primary Purpose

Cutaneous Leishmaniasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sodium stibogluconate (Pentostam)
ThermoMed
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Leishmaniasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Department of Defense (DOD) Healthcare beneficiary
  • Parasitologic diagnosis of cutaneous Leishmania infection

(Inclusion criteria for randomization includes that must be Leishmania major species)

  • Willing to locate to WRAMC area during treatment and perform subsequent follow-up visits if needed

(If not active duty on orders, then the participant will bear the cost of food and lodging during the initial 10-day outpatient treatment period at Walter Reed Army Medical Center)

  • Able to provide informed consent
  • All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving sodium stibogluconate

Exclusion Criteria:

  • Unable to provide informed consent
  • Pregnancy (females of child bearing potential must have negative urine human chorionic gonadotropic hormone [HCG] within 48 hours of the start of infusion period)
  • History of hypersensitivity to pentavalent antimonials

  • Serious medical illness:

    1. QTc interval >/= 0.5 sec
    2. severe cardiac disease
    3. history of current pancreatitis
    4. liver failure or active hepatitis with transaminases >3X normal
    5. renal failure or creatinine >2.5
    6. thrombocytopenia (platelets <75,000)
    7. white blood cell count <2000
    8. hematocrit <25
    9. absence of palpable extremity pulses in the limb requiring treatment
  • History of serious allergic reaction to local anesthetics
  • Location of lesion not amenable to local therapy (such as close to eye, mucous membranes, face, cartilage)
  • Presence of pacemaker and/or other implanted metallic devices
  • Breast feeding
  • Men unwilling to avoid fathering a child during and/or in the two months following receiving the treatment
  • Women unwilling to avoid pregnancy for at least two months after receiving the treatment
  • More than 20 lesions, or multiple lesions which in the opinion of the investigator would not be well treated with heat therapy

Sites / Locations

  • Walter Reed Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sodium stibogluconate intravenous

ThermoMed device

Arm Description

20 mg/kg/day Sodium stibogluconate intravenous

ThermoMed device, single heat treatment at 50 degrees Celsius

Outcomes

Primary Outcome Measures

Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.

Secondary Outcome Measures

Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
Determine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.
Number of Participants With Solicited Adverse Events
To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events
Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments
Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.
Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments
Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Evaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject's infecting parasite. If an L. major infection could not be confirmed in a subject's lesion(s), then that subject could not be treated under this protocol.

Full Information

First Posted
April 17, 2009
Last Updated
December 30, 2019
Sponsor
U.S. Army Medical Research and Development Command
Collaborators
Walter Reed Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00884377
Brief Title
Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
Official Title
A Phase I/II Randomized Comparison of Localized Heat Therapy Versus Sodium Stibogluconate (Pentostam) for the Treatment of Old World Cutaneous Leishmaniasis (HSRRB Log No. A-12364)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
March 2009 (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 Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device.
Detailed Description
A total of 56 Department of Defense health care beneficiaries, 18 years of age or older and diagnosed with cutaneous leishmaniasis, were planned to be treated with either intravenous sodium stibogluconate (Pentostam-TM) or the ThermoMed-TM device of Thermosurgery Technologies, Inc. at the Walter Reed Army Medical Center. Pentostam is the standard of care for this disease, but the i.v. administration and the many known side effects prompt the search for an improved method of treating this disease, especially for milder cases. This study compares the safety and efficacy of these two treatment approached.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Leishmaniasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium stibogluconate intravenous
Arm Type
Active Comparator
Arm Description
20 mg/kg/day Sodium stibogluconate intravenous
Arm Title
ThermoMed device
Arm Type
Experimental
Arm Description
ThermoMed device, single heat treatment at 50 degrees Celsius
Intervention Type
Drug
Intervention Name(s)
Sodium stibogluconate (Pentostam)
Other Intervention Name(s)
Pentostam, WR 229,870
Intervention Description
intravenous 20 mg/kg/day for 10 days
Intervention Type
Device
Intervention Name(s)
ThermoMed
Intervention Description
ThermoMed heat treatment device, one treatment
Primary Outcome Measure Information:
Title
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
Description
Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.
Time Frame
Assessment of cure is made at 2 months after treatment
Secondary Outcome Measure Information:
Title
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
Description
Determine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.
Time Frame
12 months
Title
Number of Participants With Solicited Adverse Events
Description
To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events
Time Frame
Days 3, 7 and 10
Title
Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments
Description
Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.
Time Frame
day 1 and day 10
Title
Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments
Description
Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.
Time Frame
day 1 and day 10
Title
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
Description
Evaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject's infecting parasite. If an L. major infection could not be confirmed in a subject's lesion(s), then that subject could not be treated under this protocol.
Time Frame
at baseline before treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Department of Defense (DOD) Healthcare beneficiary Parasitologic diagnosis of cutaneous Leishmania infection (Inclusion criteria for randomization includes that must be Leishmania major species) Willing to locate to WRAMC area during treatment and perform subsequent follow-up visits if needed (If not active duty on orders, then the participant will bear the cost of food and lodging during the initial 10-day outpatient treatment period at Walter Reed Army Medical Center) Able to provide informed consent All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving sodium stibogluconate Exclusion Criteria: Unable to provide informed consent Pregnancy (females of child bearing potential must have negative urine human chorionic gonadotropic hormone [HCG] within 48 hours of the start of infusion period) History of hypersensitivity to pentavalent antimonials Serious medical illness: QTc interval >/= 0.5 sec severe cardiac disease history of current pancreatitis liver failure or active hepatitis with transaminases >3X normal renal failure or creatinine >2.5 thrombocytopenia (platelets <75,000) white blood cell count <2000 hematocrit <25 absence of palpable extremity pulses in the limb requiring treatment History of serious allergic reaction to local anesthetics Location of lesion not amenable to local therapy (such as close to eye, mucous membranes, face, cartilage) Presence of pacemaker and/or other implanted metallic devices Breast feeding Men unwilling to avoid fathering a child during and/or in the two months following receiving the treatment Women unwilling to avoid pregnancy for at least two months after receiving the treatment More than 20 lesions, or multiple lesions which in the opinion of the investigator would not be well treated with heat therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
COL Naomi Aronson, M.D.
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20231896
Citation
Aronson NE, Wortmann GW, Byrne WR, Howard RS, Bernstein WB, Marovich MA, Polhemus ME, Yoon IK, Hummer KA, Gasser RA Jr, Oster CN, Benson PM. A randomized controlled trial of local heat therapy versus intravenous sodium stibogluconate for the treatment of cutaneous Leishmania major infection. PLoS Negl Trop Dis. 2010 Mar 9;4(3):e628. doi: 10.1371/journal.pntd.0000628.
Results Reference
derived

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

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