Skin and Soft Tissue (SST) InfectionNCT05423756
INSPIRE Trial for Skin and Soft Tissue Infections
A study testing Arm 1: Routine Care and Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection in people with Skin and Soft Tissue (SST) Infection, run by Harvard Pilgrim Health Care at 102 sites in United States.
Trial summary
The INSPIRE Skin and Soft Tissue Infection trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin and Soft Tissue (SST) Infection
- What is being tested?
- Arm 1: Routine Care and Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118,562 participants
- Where
- 102 sitesUnited States
- Study dates
- 1 Jan 2023to 9 May 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Facility Inclusion Criteria:
- HCA Healthcare hospitals admitting adults for skin and soft tissue infection
- Facility use of MEDITECH as their electronic health record system
Facility Exclusion Criteria:
-
Note: unit of randomization is the hospital, however the computerized physician order entry (CPOE) alert intervention will calculate risk estimates for adults age >=18 admitted to non-intensive care unit wards and who are ordered to receive extended-spectrum antibiotics for skin and soft tissue infection.
Trial locations and contacts
102 sites in 1 country.
102 sites in 1 country
United States102 sites
Medical City Arlington
Arlington, Texas, 76015
The Medical Center of Aurora
Aurora, Colorado, 80012
St. David's Medical Center
Austin, Texas, 78705
St. David's North Austin Medical Center
Austin, Texas, 78758
LewisGale Hospital Montgomery
Blacksburg, Virginia, 24060
TriStar Greenview Regional Hospital
Bowling Green, Kentucky, 42104
Blake Medical Center
Bradenton, Florida, 34209
Brandon Regional Hospital
Brandon, Florida, 33511
Oak Hill Hospital
Brooksville, Florida, 34613
Valley Regional Medical Center
Brownsville, Texas, 78526
Trident Medical Center
Charleston, South Carolina, 29406
Parkridge Medical Center
Chattanooga, Tennessee, 37404
Parkridge East Hospital
Chattanooga, Tennessee, 37412
HCA Houston Healthcare Conroe
Conroe, Texas, 77304
Corpus Christi Medical Center - Doctors Regional
Corpus Christi, Texas, 78411
Corpus Christi Medical Center - Bay Area
Corpus Christi, Texas, 78412
Corpus Christi Medical Center - Heart Hospital
Corpus Christi, Texas, 78412
Lakeview Regional Medical Center
Covington, Louisiana, 70433
Medical City Dallas
Dallas, Texas, 75230
Medical City Denton
Denton, Texas, 76210
TriStar Horizon Medical Center
Dickson, Tennessee, 37055
Fairview Park Hospital
Dublin, Georgia, 31040
Las Palmas Medical Center
El Paso, Texas, 79902
Del Sol Medical Center
El Paso, Texas, 79925
Swedish Medical Center
Englewood, Colorado, 80113
Englewood Community Hospital
Englewood, Florida, 34223
Fort Walton Beach Medical Center
Fort Walton Beach, Florida, 32547
Medical City Fortworth
Fort Worth, Texas, 76104
Medical City Alliance
Fort Worth, Texas, 76177
Medical City Frisco
Frisco, Texas, 75034
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34950
TriStar Hendersonville Medical Center
Hendersonville, Tennessee, 37075
John Randolph Medical Center
Hopewell, Virginia, 23860
HCA Houston Healthcare West
Houston, Texas, 77082
Regional Medical Center Bayonet Point
Hudson, Florida, 34667
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, 83404
Centerpoint Medical Center
Independence, Missouri, 64057
Medical City Las Colinas
Irving, Texas, 75039
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216
Research Medical Center
Kansas City, Missouri, 64132
HCA Houston Healthcare Kingwood
Kingwood, Texas, 77339
Lake City Medical Center
Lake City, Florida, 32055
Largo Medical Center
Largo, Florida, 33770
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
Southern Hills Hospital & Medical Center
Las Vegas, Nevada, 89148
Lee's Summit Medical Center
Lee's Summit, Missouri, 64063
Medical City Lewisville
Lewisville, Texas, 75057
Methodist Hospital | Metropolitan
Live Oak, Texas, 78212
Methodist Hospital | Northeast
Live Oak, Texas, 78233
Sky Ridge Medical Center
Lone Tree, Colorado, 80124
Northwest Medical Center
Margate, Florida, 33060
Rio Grande Regional Hospital Main Campus
McAllen, Texas, 78503
Medical City McKinney
McKinney, Texas, 75069
Mercy Hospital
Miami, Florida, 33133
Kendall Regional Medical Center
Miami, Florida, 33175
Grand Strand Medical Center
Myrtle Beach, South Carolina, 29572
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
TriStar Southern Hills Medical Center
Nashville, Tennessee, 37211
Tulane Medical Center
New Orleans, Louisiana, 70112
Medical City North Hills
North Richland Hills, Texas, 76180
Ogden Regional Medical Center
Ogden, Utah, 84405
Orange Park Medical Center
Orange Park, Florida, 32073
Menorah Medical Center
Overland Park, Kansas, 66209
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
Oviedo Medical Center
Oviedo, Florida, 32765
Gulf Coast Regional Medical Center
Panama City, Florida, 32405
HCA Houston Healthcare Southeast
Pasadena, Texas, 77504
HCA Houston Healthcare Pearland
Pearland, Texas, 77584
Medical City Plano
Plano, Texas, 75075
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952
St. Lucie Medical Center
Port Saint Lucie, Florida, 34952
LewisGale Hospital Pulaski
Pulaski, Virginia, 24301
Reston Hospital Center
Reston, Virginia, 20190
Henrico Doctor's Hospital
Richmond, Virginia, 23220
CJW Medical Center (Chippenham & Johnston Willis Campuses)
Richmond, Virginia, 23225
Riverside Community hospital
Riverside, California, 92501
St. David's Round Rock Medical Center
Round Rock, Texas, 78681
LewisGale Medical Center
Salem, Virginia, 24153
Methodist Hospital | Texsan
San Antonio, Texas, 78201
Methodist Hospital | Specialty and Trasnplant
San Antonio, Texas, 78229
Methodist Hospital
San Antonio, Texas, 78229
Regional Medical Center of San Jose
San Jose, California, 95116
Good Samaritan Hospital
San Jose, California, 95124
Doctors Hospital of Sarasota
Sarasota, Florida, 34233
TriStar StoneCrest Medical Center
Smyrna, Tennessee, 37167
Palms of Pasadena
St. Petersburg, Florida, 33707
Northside Hospital
St. Petersburg, Florida, 33709
St. Petersburg General Hospital
St. Petersburg, Florida, 33710
South Bay Hospital
Sun City Center, Florida, 33573
Capital Regional Medical Center
Tallahassee, Florida, 32308
HCA Florida South Tampa Hospital
Tampa, Florida, 33609
HCA Florida West Tampa Hospital
Tampa, Florida, 33615
HCA Houston Healthcare Mainland
Texas City, Texas, 77591
North Suburban Medical Center
Thornton, Colorado, 80229
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
Medical Center of Trinity
Trinity, Florida, 34655
Medical City Weatherford
Weatherford, Texas, 76086
HCA Houston Healthcare Clear Lake
Webster, Texas, 77598
West Hills Hospital & Medical Center
West Hills, California, 91307
JFK Medical Center - North Campus
West Palm Beach, Florida, 33407
Wesley Medical Center
Wichita, Kansas, 67214
Wesley Woodlawn Hospital & ER
Wichita, Kansas, 67220
About this study
Official title: The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Skin and Soft Tissue (SST) Infections
The INSPIRE Skin and Soft Tissue Infection trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with skin and soft tissue infection is infected with a resistant pathogen.
Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.
- Conditions
- Skin and Soft Tissue (SST) Infection
- Being tested
- Arm 1: Routine Care, Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection
- Keywords
- SST, CPOE, Empiric Therapy
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: Routine CareOther
Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue InfectionOther
Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Routine Care | Active comparator | Continuation of routine antibiotic stewardship strategies. Receives: Other: Arm 1: Routine Care |
| Arm 2: INSPIRE Stewardship Bundle | Active comparator | Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization. Receives: Other: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day
Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given.
Extended-spectrum days-of-therapy per empiric day is defined as the summed number of different extended-spectrum antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.
For example, 2 different extended-spectrum antibiotics administered at least once during each of the first 3 days would yield 6 days of extended-spectrum days-of-therapy.
Measured: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
Secondary outcomes (1)
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day
Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given.
Antipseudomonal days-of-therapy per empiric day is defined as the summed number of different antipseudomonal antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.
For example, 2 different antipseudomonal antibiotics administered at least once during each of the first 3 days would yield 6 days of antipseudomonal days-of-therapy.
Measured: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jan 2023
- Primary completion9 May 2024
- Study completion9 May 2024
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 (2)Papers the sponsor has linked to this study.
- Other trials for Skin and Soft Tissue (SST) InfectionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 118,562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Corporation of America, University of California, Irvine, University of Massachusetts, Amherst, Brigham and Women's Hospital, Rush University
- Responsible party
- Principal investigator, Richard Platt, Harvard Pilgrim Health Care
- Investigators
- Shruti Gohil, MD, MPH, Study director, UC Irvine Division of Infectious DiseasesSusan Huang, MD, MPH, Principal investigator, UC Irvine Division of Infectious DiseasesRichard Platt, MD, MS, Principal investigator, Harvard Pilgrim Health Care Institute/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423756
- Sponsor's protocol ID
- PH000763B_SST
- Status last verified
- Aug 2026
- First submitted
- 14 Jun 2022
- Last updated
- 28 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gohil SK, Septimus E, Kleinman K, Varma N, Sands KE, Avery TR, Mauricio A, Sljivo S, Rahm R, Roemer K, Cooper WS, McLean LE, Nickolay NG, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith KN, Meador B, Froman A, Eibensteiner K, Hayden MK, Kubiak DW, Burks C, Burgess LH, Calderwood MS, Perlin JB, Platt R, Huang SS. Improving Empiric Antibiotic Selection for Patients Hospitalized With Skin and Soft Tissue Infection: The INSPIRE 3 Skin and Soft Tissue Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):680-691. doi: 10.1001/jamainternmed.2025.0887.
PubMed 40208610Gohil SK, Avery TR, Kleinman K, Septimus E, Mauricio A, Sands KE, Varma N, Sljivo S, Roemer K, Cooper WS, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith-Sells KN, Hayden MK, Kubiak DW, Burks C, Platt R, Huang SS, Baker MA. Improving Empiric Antibiotic Selection for Patients With Cancer Hospitalized With Infection: Secondary Analysis of the INSPIRE Cluster Randomized Trials. JAMA Netw Open. 2026 Jun 1;9(6):e2616611. doi: 10.1001/jamanetworkopen.2026.16611.
PubMed 42268612
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Skin and Soft Tissue (SST) Infections
- ClinicalTrials.gov ID
- NCT05423756
- Acronym / sponsor ID
- PH000763B_SST
- Conditions
- Skin and Soft Tissue (SST) Infection
- Keywords
- SST, CPOE, Empiric Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118,562 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- Hospital Corporation of America, University of California, Irvine, University of Massachusetts, Amherst, Brigham and Women's Hospital, Rush University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The INSPIRE Skin and Soft Tissue Infection trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with skin and soft tissue infection is infected with a resistant pathogen.
Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Routine Care | Active comparator | Other: Arm 1: Routine CareContinuation of routine antibiotic stewardship strategies. |
| Arm 2: INSPIRE Stewardship Bundle | Active comparator | Other: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue InfectionUse of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Arm 1: Routine CareRoutine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards. | Other | Arm 1: Routine Care |
| Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue InfectionQuality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards. | Other | Arm 2: INSPIRE Stewardship Bundle |
Primary outcome
Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day
Time frame: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given. Extended-spectrum days-of-therapy per empiric day is defined as the summed number of different extended-spectrum antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. For example, 2 different extended-spectrum antibiotics administered at least once during each of the first 3 days would yield 6 days of extended-spectrum days-of-therapy.
1 secondary outcome
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day
Time frame: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40208610Gohil SK, Septimus E, Kleinman K, Varma N, Sands KE, Avery TR, Mauricio A, Sljivo S, Rahm R, Roemer K, Cooper WS, McLean LE, Nickolay NG, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith KN, Meador B, Froman A, Eibensteiner K, Hayden MK, Kubiak DW, Burks C, Burgess LH, Calderwood MS, Perlin JB, Platt R, Huang SS. Improving Empiric Antibiotic Selection for Patients Hospitalized With Skin and Soft Tissue Infection: The INSPIRE 3 Skin and Soft Tissue Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):680-691. doi: 10.1001/jamainternmed.2025.0887.
- Derived from this study: PubMed 42268612Gohil SK, Avery TR, Kleinman K, Septimus E, Mauricio A, Sands KE, Varma N, Sljivo S, Roemer K, Cooper WS, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith-Sells KN, Hayden MK, Kubiak DW, Burks C, Platt R, Huang SS, Baker MA. Improving Empiric Antibiotic Selection for Patients With Cancer Hospitalized With Infection: Secondary Analysis of the INSPIRE Cluster Randomized Trials. JAMA Netw Open. 2026 Jun 1;9(6):e2616611. doi: 10.1001/jamanetworkopen.2026.16611.
- Individual participant dataSharing planned: No
Related trials for Skin and Soft Tissue (SST) Infection
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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.
Shruti Gohil, MD, MPH study director
UC Irvine Division of Infectious Diseases
Susan Huang, MD, MPH principal investigator
UC Irvine Division of Infectious Diseases
Richard Platt, MD, MS principal investigator
Harvard Pilgrim Health Care Institute/Harvard Medical School
102 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: Routine Care and Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection in people with Skin and Soft Tissue (SST) Infection, run by Harvard Pilgrim Health Care at 102 sites 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?
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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). 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?
Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day (time frame: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods). 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 NCT05423756, which also lists 2 linked publications.
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 28 Aug 2026.