INSPIRE Trial for Skin and Soft Tissue Infections
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ClinicalTrials.gov Identifier: NCT05423756 |
Recruitment Status :
Active, not recruiting
First Posted : June 21, 2022
Last Update Posted : January 18, 2024
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | June 14, 2022 | |||||||||
First Posted Date ICMJE | June 21, 2022 | |||||||||
Last Update Posted Date | January 18, 2024 | |||||||||
Actual Study Start Date ICMJE | August 2, 2022 | |||||||||
Estimated Primary Completion Date | December 2027 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Empiric Extended-Spectrum Antibacterial Days of Therapy (Empiric ES-DOT) [ Time Frame: 12 month intervention ] The number of different extended-spectrum antibacterials on each of the first 3 days of hospitalization.
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
Antipseudomonal Antibiotic Days of Therapy per Empiric Day [ Time Frame: 12 months ] The number of different antipseudomonal antibiotics, per empiric day, summed across the first 3 days of hospitalization.
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | INSPIRE Trial for Skin and Soft Tissue Infections | |||||||||
Official Title ICMJE | The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Skin and Soft Tissue (SST) Infections | |||||||||
Brief 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 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. |
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Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Not Applicable | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Cluster randomized controlled trial Masking: None (Open Label)Primary Purpose: Other |
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Condition ICMJE | Skin and Soft Tissue (SST) Infection | |||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Active, not recruiting | |||||||||
Actual Enrollment ICMJE |
102 | |||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||
Estimated Study Completion Date ICMJE | December 2028 | |||||||||
Estimated Primary Completion Date | December 2027 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Facility Inclusion Criteria:
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT05423756 | |||||||||
Other Study ID Numbers ICMJE | PH000763B_SST | |||||||||
Has Data Monitoring Committee | No | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | |||||||||
Current Responsible Party | Richard Platt, Harvard Pilgrim Health Care | |||||||||
Original Responsible Party | Same as current | |||||||||
Current Study Sponsor ICMJE | Harvard Pilgrim Health Care | |||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Harvard Pilgrim Health Care | |||||||||
Verification Date | January 2024 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |