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

NCT ID: NCT00884377

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2009-03-31

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.

Conditions

Cutaneous Leishmaniasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sodium stibogluconate intravenous

20 mg/kg/day Sodium stibogluconate intravenous

Group Type: ACTIVE_COMPARATOR

Sodium stibogluconate (Pentostam)

Intervention Type: DRUG

intravenous 20 mg/kg/day for 10 days

ThermoMed device

ThermoMed device, single heat treatment at 50 degrees Celsius

Group Type: EXPERIMENTAL

ThermoMed

Intervention Type: DEVICE

ThermoMed heat treatment device, one treatment

Interventions

Sodium stibogluconate (Pentostam)

intravenous 20 mg/kg/day for 10 days

Intervention Type: DRUG

ThermoMed

ThermoMed heat treatment device, one treatment

Intervention Type: DEVICE

Other Intervention Names

Pentostam; WR 229,870

Eligibility Criteria

Inclusion Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

COL Naomi Aronson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Locations

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20231896 (View on PubMed)

Other Identifiers

A-12364

Identifier Type: -

Identifier Source: org_study_id