- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00884377
Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
December 30, 2019 updated by: U.S. Army Medical Research and Development Command
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
56
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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District of Columbia
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Washington, District of Columbia, United States, 20307
- Walter Reed Army Medical Center
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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
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sodium stibogluconate intravenous
20 mg/kg/day Sodium stibogluconate intravenous
|
intravenous 20 mg/kg/day for 10 days
Other Names:
|
Experimental: ThermoMed device
ThermoMed device, single heat treatment at 50 degrees Celsius
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ThermoMed heat treatment device, one treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
Time Frame: Assessment of cure is made at 2 months after treatment
|
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.
|
Assessment of cure is made at 2 months after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
Time Frame: 12 months
|
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.
|
12 months
|
Number of Participants With Solicited Adverse Events
Time Frame: Days 3, 7 and 10
|
To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events
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Days 3, 7 and 10
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Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments
Time Frame: day 1 and day 10
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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.
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day 1 and day 10
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Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments
Time Frame: day 1 and day 10
|
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.
|
day 1 and day 10
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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
|
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.
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at baseline before treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: COL Naomi Aronson, M.D., Uniformed Services University of the Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
February 1, 2004
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
April 17, 2009
First Submitted That Met QC Criteria
April 17, 2009
First Posted (Estimate)
April 20, 2009
Study Record Updates
Last Update Posted (Actual)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 30, 2019
Last Verified
December 1, 2019
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
- Anti-Infective Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Anthelmintics
- Schistosomicides
- Antiplatyhelmintic Agents
- Antimony Sodium Gluconate
Other Study ID Numbers
- A-12364
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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