Cutaneous LeishmaniasisPhase 2NCT00884377
Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
A Phase 2 study testing Sodium stibogluconate (Pentostam) and ThermoMed in people with Cutaneous Leishmaniasis, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Sodium stibogluconate (Pentostam) and ThermoMed
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
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)
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.
Read the 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
- Being tested
- Sodium stibogluconate (Pentostam), ThermoMed
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium stibogluconate (Pentostam)Drug
Also called Pentostam, WR 229,870
intravenous 20 mg/kg/day for 10 days
ThermoMedDevice
ThermoMed heat treatment device, one treatment
| Study group | Role | What they receive |
|---|---|---|
| Sodium stibogluconate intravenous | Active comparator | 20 mg/kg/day Sodium stibogluconate intravenous Receives: Drug: Sodium stibogluconate (Pentostam) |
| ThermoMed device | Experimental | ThermoMed device, single heat treatment at 50 degrees Celsius Receives: Device: ThermoMed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 12 months
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
Measured: Days 3, 7 and 10
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.
Measured: day 1 and day 10
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.
Measured: 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
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.
Measured: at baseline before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startFeb 2004
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Medical Center
- Responsible party
- Sponsor
- Investigators
- COL Naomi Aronson, M.D., Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884377
- Sponsor's protocol ID
- A-12364
- Status last verified
- Dec 2019
- First submitted
- 17 Apr 2009
- Last updated
- 2 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20231896
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00884377
- Acronym / sponsor ID
- A-12364
- Conditions
- Cutaneous Leishmaniasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Medical Center
- Study start
- Feb 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Posted 14 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium stibogluconate intravenous | Active comparator | Drug: Sodium stibogluconate (Pentostam)20 mg/kg/day Sodium stibogluconate intravenous |
| ThermoMed device | Experimental | Device: ThermoMedThermoMed device, single heat treatment at 50 degrees Celsius |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (20 listed)
- 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:
- History of serious allergic reaction to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium stibogluconate (Pentostam)Also: Pentostam, WR 229,870intravenous 20 mg/kg/day for 10 days | Drug | Sodium stibogluconate intravenous |
| ThermoMedThermoMed heat treatment device, one treatment | Device | ThermoMed device |
Primary outcome
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure
Time frame: 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.
5 secondary outcomes
Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure
Time frame: 12 months
Number of Participants With Solicited Adverse Events
Time frame: Days 3, 7 and 10
Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments
Time frame: day 1 and day 10
Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments
Time frame: 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
Time frame: at baseline before treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20231896Aronson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
COL Naomi Aronson, M.D. principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium stibogluconate (Pentostam) and ThermoMed in people with Cutaneous Leishmaniasis, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure (time frame: Assessment of cure is made at 2 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00884377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.