Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BRAHMS GmbH | UNKNOWN |
| Thermo Fisher Scientific, Inc | INDUSTRY |
Not provided
Not provided
Not provided
Trials comparing PCT-guided antibiotic algorithms to standard management show a significant reduction in antibiotic exposure without an increase in mortality or treatment failure. Despite this strong evidence from multiple studies a recent prospective multicentric interventional trial in the US fell short of demonstrating antibiotic reductions by PCT-guided antibiotic management. Amongst other limitations the authors of that study concluded that successful implementation of PCT may require closer educational oversight. As such, this study will compare effectiveness and safety of antibiotic prescription guided by a PCT-algorithm via a Stewardship Team over standard guidelines in hospitalized adult patients with suspected or confirmed LRTI (including sepsis with respiratory focus).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procalcitonin algorithm+stewardship team | Experimental | antibiotic prescription guided by PCT values |
|
| standard group | No Intervention | standard of care guided by current guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| procalcitonin | Diagnostic Test | accuracy of procalcitonin as a diagnostic marker in guiding antibiotic therapy in patients with a lower respiratory tract infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short Treatment of Pneumonia | Proportion of patients with short treatment of pneumonia with antibiotics (less than 4 days, "shortABx") | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Safety Adverse Event Rate | Composite endpoints include: all-cause in-hospital mortality, all-cause mortality after discharge (as available), hospital readmission, septic shock (vasopressor use for > 1 hour), mechanical ventilation (via endotracheal tube), required dialysis, lung abscess/empyema/cavitation/necrotizing pneumonia | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clostridium Difficile Infection (CDI) | Treatment or readmission for CDI until day 30 after enrollment | 30 days |
| Healthcare Economic Endpoints | Costs associated with primary hospitalization, readmission for CDI, and loss of function |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael K Mansour, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charlotte Hungerford Hospital | Torrington | Connecticut | 06790 | United States | ||
| Grady Memorial Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care (SOC) | PCT results were hidden from the medical record and no ASP recommendation given. |
| FG001 | PCT/ASP | PCT results were posted in the medical record and ASP emailed recommendation to the medical team. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2023 | Jan 9, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Antibiotic Exposure at Discharge | Duration of antibiotics prescribed at discharge | 30 days |
| Days of Therapy Per 1000 Patient Days | Days of therapy per 1000 patient days (inclusive of antibiotics prescribed at discharge) | 30 days |
| Length of Stay | Length of stay in hospital | 30 days |
| ICU Admissions | Number of Participants Admitted to the ICU | 30 days |
| 30 days |
| Atlanta |
| Georgia |
| 30303 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Martha's Vineyard Hospital | Oak Bluffs | Massachusetts | 02557 | United States |
| North Shore Medical Center | Salem | Massachusetts | 01970 | United States |
| Texas Health Harris Methodist Hospital | Fort Worth | Texas | 76104 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care (SOC) | PCT results were hidden from the medical record and no ASP recommendation given. |
| BG001 | PCT/ASP | PCT results were posted in the medical record and ASP emailed recommendation to the medical team. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Pneumonia Type | Count of Participants | Participants |
| ||||||||||||||||
| Pneumonia Severity Index (PSI) | The Pneumonia Severity Index is a clinical tool used to assess the severity of pneumonia based on several clinical factors, including demographics, comorbidities, physical exam findings, vital signs, and lab and imaging results. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Short Treatment of Pneumonia | Proportion of patients with short treatment of pneumonia with antibiotics (less than 4 days, "shortABx") | Posted | Count of Participants | Participants | 30 days |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Composite Safety Adverse Event Rate | Composite endpoints include: all-cause in-hospital mortality, all-cause mortality after discharge (as available), hospital readmission, septic shock (vasopressor use for > 1 hour), mechanical ventilation (via endotracheal tube), required dialysis, lung abscess/empyema/cavitation/necrotizing pneumonia | Posted | Count of Participants | Participants | 30 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Antibiotic Exposure at Discharge | Duration of antibiotics prescribed at discharge | Posted | Median | Inter-Quartile Range | days | 30 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Days of Therapy Per 1000 Patient Days | Days of therapy per 1000 patient days (inclusive of antibiotics prescribed at discharge) | Posted | Median | Inter-Quartile Range | Days of Therapy Per 1000 Patient Days | 30 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Length of Stay | Length of stay in hospital | Posted | Median | Inter-Quartile Range | days | 30 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | ICU Admissions | Number of Participants Admitted to the ICU | Posted | Count of Participants | Participants | 30 days |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Clostridium Difficile Infection (CDI) | Treatment or readmission for CDI until day 30 after enrollment | Not Posted | 30 days | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Healthcare Economic Endpoints | Costs associated with primary hospitalization, readmission for CDI, and loss of function | Not Posted | 30 days | Participants |
Adverse event data was collected starting at enrollment day until 30 days after enrollment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care (SOC) | PCT results were hidden from the medical record and no ASP recommendation given. | 19 | 357 | 76 | 357 | 0 | 357 |
| EG001 | PCT/ASP | PCT results were posted in the medical record and ASP emailed recommendation to the medical team. | 17 | 343 | 81 | 343 | 0 | 343 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
| ||
| Septic Shock | Infections and infestations | Non-systematic Assessment |
| ||
| Mechanical Ventilation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dialysis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Empyema | Infections and infestations | Non-systematic Assessment |
| ||
| Readmission | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael K. Mansour, MD, Ph.D. | Massachusetts General Hospital | 617-726-6726 | mkmansour@mgb.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2023 | Jan 9, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| HCAP (healthcare-associated pneumonia) |
|
| Aspiration |
|
| Other |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Class V (highest severity) |
|
|
|
|
|
|