Phase 2
N=56
Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
Cutaneous Leishmaniasis
Bottom Line
View on ClinicalTrials.gov: NCT00884377 ↗Enrolled (actual)
56
Serious AEs
12.5%
Results posted
Jul 2017
Primary outcome: Primary: Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure — 22; 18; 5; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sodium stibogluconate (Pentostam) (Drug); ThermoMed (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure |
22; 18; 5; 9; 1; 1 | — |
| SECONDARY Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure |
25; 23; 2; 4; 1; 1 | — |
| SECONDARY Number of Participants With Solicited Adverse Events |
4; 1; 3; 0; 5; 0 | — |
| SECONDARY Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments |
515.89; 534.19; 368.74; 500.15; 375.37; 328.27 | — |
| SECONDARY Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments |
25.07; 26.54; 25.67; 26.85; 17.96; 16.73 | — |
| SECONDARY Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial |
10; 6; 18; 22; 4; 5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00884377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.