Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis - Full Text View

Sponsor:	U.S. Army Medical Research and Materiel Command
Collaborator:	Walter Reed Army Medical Center
Information provided by:	U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:	NCT00884377

Purpose

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.

Condition	Intervention	Phase
Cutaneous Leishmaniasis	Drug: Sodium stibogluconate (Pentostam) Device: ThermoMed	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis

U.S. FDA Resources

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:

The primary objective is to assess if local heat treatment with the ThermoMed device is equivalent in efficacy to 10 days of parenteral sodium stibogluconate [ Time Frame: Assessment of cure is made at 2 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine efficacy of heat vs SSG for all lesions at 12 mos after treatment start. [ Time Frame: final assessment is at 6 months following treatment ] [ Designated as safety issue: Yes ]
Compare the toxicity profiles of heat versus parenteral SSG therapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Evaluate the immune response to leishmania before, and on day 10 and 6 months following treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Establish the feasibility of a L. major species specific polymerase chain reaction as a rapid diagnostic device in the context of a treatment trial. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	February 2004
Study Completion Date:	March 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Sodium stibogluconate intravenous	Drug: Sodium stibogluconate (Pentostam) intravenous 20 mg/kg/day for 10 days Other Names: Pentostam WR 229,870
Experimental: 2 ThermoMed device	Device: ThermoMed ThermoMed heat treatment device, one treatment

Detailed Description:

A total of 60 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884377

Locations

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

U.S. Army Medical Research and Materiel Command

Walter Reed Army Medical Center

Investigators

Principal Investigator:

COL Naomi Aronson, M.D.

Uniformed Services University of the Health Sciences

More Information

No publications provided

Responsible Party:	COL Naomi E. Aronson, M.D., Walter Reed Army Institute of Research
ClinicalTrials.gov Identifier:	NCT00884377 History of Changes
Other Study ID Numbers:	A-12364
Study First Received:	April 17, 2009
Last Updated:	April 17, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antimony Sodium Gluconate

Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents

ClinicalTrials.gov processed this record on May 23, 2012