Cutaneous Leishmaniasis
Conditions
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.
Interventions
intravenous 20 mg/kg/day for 10 days
DEVICEThermoMed
ThermoMed heat treatment device, one treatment
Sponsors
Walter Reed Army Medical Center
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | 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. |
| Number of Participants With Solicited Adverse Events | Days 3, 7 and 10 | To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events |
| Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | 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. |
| Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Fifty Six subjects were recruited from the Infectious Disease Clinic at Walter Reed Army Medical Center from February 2004 to March 2009. At 2 months post-treatment, subjects assessed as having failed therapy were eligible for crossover to an alternate treatment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment With IV Sodium Stibogluconate Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic. | 28 |
| Treatment With Thermomed Device Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated | 28 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Could not confirm diagnosis | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment With Thermomed Device | Treatment With IV Sodium Stibogluconate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 28 Participants | 56 Participants |
| Age, Continuous | 28.9 years STANDARD_DEVIATION 8.3 | 27.0 years STANDARD_DEVIATION 9.7 | 27.9 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 28 participants | 28 participants | 60 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 28 Participants | 27 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 28 / 28 | 28 / 28 |
| serious Total, serious adverse events | 5 / 28 | 2 / 28 |
Outcome results
Primary
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.
Time frame: Assessment of cure is made at 2 months after treatment
Population: A sample size of 27 subjects per treatment group was planned based on the assumption that the cure rate in the heat treatment arm would be 73% (Navin et al., 1990), compared to a 99% cure rate in the sodium stibogluconate arm (Wortmann et al., 2002).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sodium Stibogluconate | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Healed | 22 Participants |
| Sodium Stibogluconate | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Not Healed | 5 Participants |
| Sodium Stibogluconate | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Not Applicable | 1 Participants |
| Sodium Stibogluconate | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Cured | 13 Participants |
| Sodium Stibogluconate | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Not Cured | 13 Participants |
| Sodium Stibogluconate | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Not Evaluable | 2 Participants |
| ThermoMed Device | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Not Cured | 14 Participants |
| ThermoMed Device | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Healed | 18 Participants |
| ThermoMed Device | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Cured | 11 Participants |
| ThermoMed Device | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Not Healed | 9 Participants |
| ThermoMed Device | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Not Evaluable | 3 Participants |
| ThermoMed Device | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Not Applicable | 1 Participants |
Secondary
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
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.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sodium Stibogluconate | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Healed | 25 Participants |
| Sodium Stibogluconate | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Not Healed | 2 Participants |
| Sodium Stibogluconate | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Not Applicable | 1 Participants |
| Sodium Stibogluconate | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Clincally Cured | 23 Participants |
| Sodium Stibogluconate | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Not Clinically Cured | 2 Participants |
| Sodium Stibogluconate | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Not Evaluable | 3 Participants |
| ThermoMed Device | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Not Clinically Cured | 2 Participants |
| ThermoMed Device | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Healed | 23 Participants |
| ThermoMed Device | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Clincally Cured | 21 Participants |
| ThermoMed Device | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Not Healed | 4 Participants |
| ThermoMed Device | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Not Evaluable | 5 Participants |
| ThermoMed Device | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Not Applicable | 1 Participants |
Secondary
Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial
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.
Time frame: at baseline before treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Histopathology: Amastigotes absent | 10 Participants |
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Histopathology: Amastigotes present | 18 Participants |
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture: Not done | 4 Participants |
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture: Unknown | 0 Participants |
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture: Negative | 6 Participants |
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture: Positive | 18 Participants |
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture/Isoenzyme Analysis: L.major = Positive | 12 Participants |
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture/Isoenzyme analysis: Unknown Leish species | 2 Participants |
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture/Isoenzyme analysis: Not done | 4 Participants |
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | PCR (Genus) = Positive for Leish genus | 28 Participants |
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | PCR (Species) = Positive for L.major species | 27 Participants |
| Sodium Stibogluconate | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | PCR (Species) = Unknown | 1 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | PCR (Species) = Positive for L.major species | 28 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Histopathology: Amastigotes absent | 6 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture/Isoenzyme Analysis: L.major = Positive | 12 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Histopathology: Amastigotes present | 22 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | PCR (Genus) = Positive for Leish genus | 28 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture: Not done | 5 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture/Isoenzyme analysis: Unknown Leish species | 3 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture: Unknown | 1 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | PCR (Species) = Unknown | 0 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture: Negative | 4 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture/Isoenzyme analysis: Not done | 4 Participants |
| ThermoMed Device | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Culture: Positive | 18 Participants |
Secondary
Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments
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.
Time frame: day 1 and day 10
Population: Percent of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sodium Stibogluconate | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD16+CD56 (%) | 9.67 % of T-cells |
| Sodium Stibogluconate | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD3+CD8 (%) | 25.07 % of T-cells |
| Sodium Stibogluconate | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD19 (%) | 17.96 % of T-cells |
| ThermoMed Device | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD19 (%) | 16.73 % of T-cells |
| ThermoMed Device | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD3+CD8 (%) | 26.54 % of T-cells |
| ThermoMed Device | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD16+CD56 (%) | 10.73 % of T-cells |
| Study Day 1: ThermoMed | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD16+CD56 (%) | 9.81 % of T-cells |
| Study Day 1: ThermoMed | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD3+CD8 (%) | 25.67 % of T-cells |
| Study Day 1: ThermoMed | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD19 (%) | 15.30 % of T-cells |
| Study Day 10: ThermoMed | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD19 (%) | 15.11 % of T-cells |
| Study Day 10: ThermoMed | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD3+CD8 (%) | 26.85 % of T-cells |
| Study Day 10: ThermoMed | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | CD16+CD56 (%) | 11.74 % of T-cells |
Secondary
Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments
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.
Time frame: day 1 and day 10
Population: Populations of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sodium Stibogluconate | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD3+CD8 (cells/uL) | 515.89 populations of T-cells |
| Sodium Stibogluconate | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD16+CD56 (cells/uL) | 196.52 populations of T-cells |
| Sodium Stibogluconate | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD19 (cells/uL) | 375.37 populations of T-cells |
| ThermoMed Device | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD3+CD8 (cells/uL) | 534.19 populations of T-cells |
| ThermoMed Device | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD16+CD56 (cells/uL) | 207.62 populations of T-cells |
| ThermoMed Device | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD19 (cells/uL) | 328.27 populations of T-cells |
| Study Day 1: ThermoMed | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD19 (cells/uL) | 213.85 populations of T-cells |
| Study Day 1: ThermoMed | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD3+CD8 (cells/uL) | 368.74 populations of T-cells |
| Study Day 1: ThermoMed | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD16+CD56 (cells/uL) | 137.74 populations of T-cells |
| Study Day 10: ThermoMed | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD3+CD8 (cells/uL) | 500.15 populations of T-cells |
| Study Day 10: ThermoMed | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD16+CD56 (cells/uL) | 221.96 populations of T-cells |
| Study Day 10: ThermoMed | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | ABS CD19 (cells/uL) | 274.70 populations of T-cells |
Secondary
Number of Participants With Solicited Adverse Events
To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events
Time frame: Days 3, 7 and 10
Population: Data ia showing only subjects with specified solicited symptoms on Days 3, 7 and 10. Collective count of participants for SSG is 53 and 28 for ThermoMed over all reported days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Abdominal Pain : Day 7 | 3 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Arthralgias : Day 7 | 11 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Abdominal Pain : Day 10 | 2 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Fever : Day 3 | 0 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Headache : Day 3 | 7 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Arthralgias : Day 10 | 7 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Headache : Day 7 | 9 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Myalgias : Day 3 | 4 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Diarrhea : Day 3 | 2 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Nausea : Day 3 | 3 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Diarrhea : Day 7 | 3 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Rash : Day 10 | 3 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Diarrhea : Day 10 | 3 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Nausea : Day 7 | 4 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Rash : Day 3 | 2 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Myalgias : Day 7 | 3 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Rash : Day 7 | 2 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Nausea : Day 10 | 1 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Fatigue : Day 3 | 17 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Fever : Day 7 | 2 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Fatigue : Day 7 | 11 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Vomiting : Day 3 | 1 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Fatigue : Day 10 | 9 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Myalgias : Day 10 | 5 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Chest Pain : Day 3 | 1 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Vomiting : Day 7 | 2 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Chest Pain : Day 7 | 0 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Headache : Day 10 | 5 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Chest Pain : Day 10 | 0 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Vomiting : Day 10 | 0 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Other : Day 3 | 3 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Arthralgias : Day 3 | 4 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Other : Day 7 | 6 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Abdominal Pain : Day 3 | 2 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Other : Day 10 | 2 subjects showing specified symptoms |
| Sodium Stibogluconate | Number of Participants With Solicited Adverse Events | Fever : Day 10 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Other : Day 10 | 7 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Rash : Day 10 | 1 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Fever : Day 3 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Fever : Day 7 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Fever : Day 10 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Myalgias : Day 3 | 1 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Myalgias : Day 7 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Myalgias : Day 10 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Arthralgias : Day 3 | 2 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Arthralgias : Day 7 | 2 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Arthralgias : Day 10 | 2 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Nausea : Day 3 | 1 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Nausea : Day 7 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Nausea : Day 10 | 1 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Vomiting : Day 3 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Vomiting : Day 7 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Vomiting : Day 10 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Abdominal Pain : Day 3 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Abdominal Pain : Day 7 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Abdominal Pain : Day 10 | 1 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Headache : Day 3 | 2 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Headache : Day 10 | 2 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Diarrhea : Day 3 | 1 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Diarrhea : Day 7 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Diarrhea : Day 10 | 1 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Rash : Day 3 | 1 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Rash : Day 7 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Fatigue : Day 3 | 3 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Fatigue : Day 7 | 1 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Fatigue : Day 10 | 3 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Chest Pain : Day 3 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Chest Pain : Day 7 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Chest Pain : Day 10 | 0 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Other : Day 3 | 2 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Other : Day 7 | 5 subjects showing specified symptoms |
| ThermoMed Device | Number of Participants With Solicited Adverse Events | Headache : Day 7 | 2 subjects showing specified symptoms |