Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
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)
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2004
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 17, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedResults Posted
Study results publicly available
July 14, 2017
CompletedJanuary 2, 2020
December 1, 2019
4.9 years
April 17, 2009
February 13, 2017
December 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Assessment of cure is made at 2 months after treatment
Secondary Outcomes (5)
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
12 months
Number of Participants With Solicited Adverse Events
Days 3, 7 and 10
Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments
day 1 and day 10
Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments
day 1 and day 10
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
at baseline before treatment
Study Arms (2)
Sodium stibogluconate intravenous
ACTIVE COMPARATOR20 mg/kg/day Sodium stibogluconate intravenous
ThermoMed device
EXPERIMENTALThermoMed device, single heat treatment at 50 degrees Celsius
Interventions
intravenous 20 mg/kg/day for 10 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
Related Publications (1)
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.
PMID: 20231896DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Naomi Aronson, Principal Investigator
- Organization
- Walter Reed Army Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
COL Naomi Aronson, M.D.
Uniformed Services University of the Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2009
First Posted
April 20, 2009
Study Start
February 1, 2004
Primary Completion
January 1, 2009
Study Completion
March 1, 2009
Last Updated
January 2, 2020
Results First Posted
July 14, 2017
Record last verified: 2019-12