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| Name | Class |
|---|---|
| Hospital Corporation of America | INDUSTRY |
| University of California, Irvine | OTHER |
| University of Massachusetts, Amherst | OTHER |
| Brigham and Women's Hospital |
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The INSPIRE-ASP PNA trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with PNA is infected with a resistant pathogen.
Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Care | Active Comparator | Continued routine antibiotic stewardship strategies. |
|
| INSPIRE CPOE Smart Prompt | Active Comparator | Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for PNA in non-ICU patients in the first 3 days of hospitalization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INSPIRE CPOE Smart Prompt | Other | Quality improvement intervention: computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimate of having PNA due to a multidrug resistant organism (MDRO) and recommends appropriate antibiotic choice for non-ICU patients in the first 3 days of hospitalization. Continuation of other antibiotic stewardship activities in accordance with national standards. |
| Measure | Description | Time Frame |
|---|---|---|
| Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day | The number of different extended-spectrum antibacterials received by the patient each empiric day-of-therapy (outcome measure unit), averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. | First 3 days of hospitalization for each patient during 15-month intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Vancomycin Days of Antibacterial Therapy Per Empiric Day | The number of days that Vancomycin is received by the patient averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibacterial Escalations [Safety Outcome 1] | Days from start of standard-spectrum antibacterial until switch to extended-spectrum antibacterial during hospital stay, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection. | Duration of hospitalization for each patient during 15-month intervention period |
Facility Inclusion Criteria:
Facility Exclusion Criteria:
-
Note: unit of randomization is the hospital, however the CPOE alert intervention will calculate risk estimates for adults age >=18 admitted to non-ICU wards and who are ordered to receive extended-spectrum antibiotics for PNA. Prisoners were excluded from prompts and analysis.
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| Name | Affiliation | Role |
|---|---|---|
| Shruti Gohil, MD, MPH | UC Irvine Div Infectious Diseases | Study Director |
| Susan Huang, MD, MPH | UC Irvine Div Infectious Diseases | Principal Investigator |
| Richard Platt, MD, MS | Harvard Pilgrim Health Care Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Community Hospital | Riverside | California | 92501 | United States | ||
| Regional Medical Center of San Jose |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38639729 | Result | Gohil SK, Septimus E, Kleinman K, Varma N, Avery TR, Heim L, Rahm R, Cooper WS, Cooper M, McLean LE, Nickolay NG, Weinstein RA, Burgess LH, Coady MH, Rosen E, Sljivo S, Sands KE, Moody J, Vigeant J, Rashid S, Gilbert RF, Smith KN, Carver B, Poland RE, Hickok J, Sturdevant SG, Calderwood MS, Weiland A, Kubiak DW, Reddy S, Neuhauser MM, Srinivasan A, Jernigan JA, Hayden MK, Gowda A, Eibensteiner K, Wolf R, Perlin JB, Platt R, Huang SS. Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial. JAMA. 2024 Jun 18;331(23):2007-2017. doi: 10.1001/jama.2024.6248. | |
| 42268612 |
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44,780 patients were involved in the intervention period from the 59 participating hospitals.
59 out of 143 HCA Healthcare hospitals were recruited for this trial. There was a 15 month intervention period from April 1, 2019 through June 30, 2020.
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Routine Stewardship | Continuation of all antibiotic stewardship activities in accordance with national standards. |
| FG001 | Arm 2: CPOE Bundle | Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for PNA in non-ICU patients in the first 3 days of hospitalization. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 3, 2018 | May 16, 2024 |
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| OTHER |
| Centers for Disease Control and Prevention | FED |
This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
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|
| Routine Care | Other | Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards. |
|
| First 3 days of hospitalization for each patient during 15-month intervention period |
| Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day | The number of different antipseudomonals received by the patient each empiric day of therapy, averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. | First 3 days of hospitalization for each patient during 15-month intervention period |
| ICU Transfers [Safety Outcome 2] | Days from hospital admission until transfer to ICU, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection. | Duration of hospitalization for each patient during 15-month intervention period |
| Length-of-stay [Safety Outcome 3] | Days from hospital admission until discharge. If the patient remains in the hospital at the end of the trial data collection, the number of days is censored (capped) at that time. Almost all patients will be discharged before the end of trial data collection. | Duration of hospitalization for each patient during 15-month intervention period |
| Extended-Spectrum Days of Therapy With Inpatient Extended-Spectrum (ES) Antibacterial Treatment After Empiric Period | The summed number of different ES antibacterials received each day, measured repeatedly on or after 4 calendar days of admission and divided by the number of days from hospital day 4 through discharge. Note: this outcome is intended for a secondary manuscript. | 15 month intervention |
| Empiric and Total Antibacterial Costs | Empiric and total antibacterial costs during hospitalization. Note: this outcome is intended for a secondary manuscript. | 15 month intervention |
| Incidence of Hospital-Onset C. Difficile | Hospital-onset C. difficile positive tests (specimen obtained) after 3 calendar days of admission during hospitalization. Note: this outcome is intended for a secondary manuscript. | 15 month intervention |
| Incidence of Hospital-Onset MDRO-Positive Cultures | Newly-detected hospital-onset MDRO-positive cultures (on or after 3 calendar days of admission). Includes total MDRO and specific MDRO subsets. Note: this outcome is intended for a secondary manuscript. | 15 month intervention |
| Fluoroquinolone (FQ) Days of Therapy Per Empiric and Total At-risk Days | The summed number of different fluoroquinolone antibacterials received each day, measured repeatedly over (1) the first three days (empiric) of an admission and divided by the number of days of the admission and (2) all days of an admission divided by the total number of admission days. Note: this outcome is intended for a secondary manuscript. | 15 month intervention |
| San Jose |
| California |
| 95116 |
| United States |
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | United States |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | United States |
| Swedish Medical Center | Denver | Colorado | 80113 | United States |
| Sky Ridge Medical Center | Denver | Colorado | 80124 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| Brandon Regional | Brandon | Florida | 33511 | United States |
| Fort Walton Medical Center | Fort Walton Beach | Florida | 32547 | United States |
| North Florida Regional Medical Center | Gainesville | Florida | 32605 | United States |
| Osceola Regional Medical Center | Kissimmee | Florida | 34741 | United States |
| Poinciana Medical Center | Kissimmee | Florida | 34758 | United States |
| Lake City Medical Center | Lake City | Florida | 32055 | United States |
| Largo Medical Center | Largo | Florida | 33770 | United States |
| Northwest Medical Center | Margate | Florida | 33063 | United States |
| Kendall Regional Medical Center | Miami | Florida | 33175 | United States |
| Twin Cities Hospital | Niceville | Florida | 32578 | United States |
| Putnam Community Medical Center | Palatka | Florida | 80218 | United States |
| Gulf Coast Medical Center | Panama City | Florida | 32405 | United States |
| Westside Regional Medical Center | Plantation | Florida | 33324 | United States |
| Fawcett Memorial Hospital | Port Charlotte | Florida | 33952 | United States |
| St. Lucie Medical Center | Port Saint Lucie | Florida | 34952 | United States |
| Central Florida Regional Hospital | Sanford | Florida | 32771 | United States |
| Doctor's Hospital Sarasota | Sarasota | Florida | 34233 | United States |
| Capital Regional Medical Center | Tallahassee | Florida | 32308 | United States |
| Medical Center of Trinity | Trinity | Florida | 34655 | United States |
| Cartersville Medical Center | Cartersville | Georgia | 30120 | United States |
| Fairview Park | Dublin | Georgia | 31021 | United States |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | United States |
| West Valley Medical Center | Caldwell | Idaho | 83605 | United States |
| Terre Haute Regional Hospital | Terre Haute | Indiana | 47802 | United States |
| Tulane University Hospital & Clinic | New Orleans | Louisiana | 70112 | United States |
| Centerpoint Medical Center | Independence | Missouri | 64057 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Southern Hills Hospital - Vegas | Las Vegas | Nevada | 89148 | United States |
| TriStar Horizon Medical Center | Dickson | Tennessee | 37055 | United States |
| Stonecrest Medical Center | Nashville | Tennessee | 37167 | United States |
| South Austin Hospital | Austin | Texas | 78704 | United States |
| St. David's Medical Center | Austin | Texas | 78705 | United States |
| Valley Regional Medical Center | Brownsville | Texas | 78526 | United States |
| Conroe Regional Medical Center | Conroe | Texas | 77304 | United States |
| Corpus Christi Medical Center (Doctor's, Bay Area, and The Heart Hospital Campuses) | Corpus Christi | Texas | 78411 | United States |
| Medical City Denton | Denton | Texas | 76210 | United States |
| Medical City Fort Worth | Fort Worth | Texas | 76104 | United States |
| West Houston Medical Center | Houston | Texas | 77082 | United States |
| Kingwood Medical Center | Kingwood | Texas | 77339 | United States |
| Rio Grande Regional Hospital | McAllen | Texas | 78503 | United States |
| North Hills Hospital | North Richland Hills | Texas | 76180 | United States |
| Bayshore Medical Center | Pasadena | Texas | 77504 | United States |
| Medical City Plano | Plano | Texas | 75075 | United States |
| Round Rock Hospital | Round Rock | Texas | 78681 | United States |
| Metropolitan Methodist Hospital | San Antonio | Texas | 78212 | United States |
| Clearlake Regional Medical Center | Webster | Texas | 77598 | United States |
| LewisGale Hospital - Montgomery | Blacksburg | Virginia | 24060 | United States |
| John Randolph Medical Center | Hopewell | Virginia | 23860 | United States |
| LewisGale Hospital - Pulaski | Pulaski | Virginia | 24301 | United States |
| Reston Hospital | Reston | Virginia | 20190 | United States |
| CJW Medical Center (Chippenham & Johnston Willis Campuses) | Richmond | Virginia | 23225 | United States |
| Henrico Doctors' Hospital (Forest, Retreat, and Parham Campuses) | Richmond | Virginia | 23229 | United States |
| Derived |
| Gohil 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. |
| COMPLETED |
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| NOT COMPLETED |
|
Number of participant totals reflect total intervention participants. 59 hospitals were randomized to a study group, 29 began the assigned intervention and 30 continued routine care.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Routine Stewardship | Continuation of all antibiotic stewardship activities in accordance with national standards. |
| BG001 | Arm 2: CPOE Bundle | Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for PNA in non-ICU patients in the first 3 days of hospitalization. INSPIRE CPOE Smart Prompt: Quality improvement intervention: computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimate of having PNA due to a multidrug resistant organism (MDRO) and recommends appropriate antibiotic choice for non-ICU patients in the first 3 days of hospitalization. Continuation of other antibiotic stewardship activities in accordance with national standards. |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Small differences in the number of patients with various characteristics reflect missing data in the electronic health record. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Small differences in the number of patients with various characteristics reflect missing data in the electronic health record. | 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 | Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day | The number of different extended-spectrum antibacterials received by the patient each empiric day-of-therapy (outcome measure unit), averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. | The total number of participants analyzed reported here is from the intervention period. | Posted | Number | Extended-Spectrum Days-of-Therapy | First 3 days of hospitalization for each patient during 15-month intervention period |
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| Secondary | Vancomycin Days of Antibacterial Therapy Per Empiric Day | The number of days that Vancomycin is received by the patient averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. | The total number of participants analyzed reported here is from the intervention period. | Posted | Number | Vancomycin Days-of-Therapy | First 3 days of hospitalization for each patient during 15-month intervention period |
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| Secondary | Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day | The number of different antipseudomonals received by the patient each empiric day of therapy, averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. | The total number of participants analyzed reported here is from the intervention period. | Posted | Number | Antipseudomonal Days-of-Therapy | First 3 days of hospitalization for each patient during 15-month intervention period |
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| Other Pre-specified | Antibacterial Escalations [Safety Outcome 1] | Days from start of standard-spectrum antibacterial until switch to extended-spectrum antibacterial during hospital stay, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection. | The mean number of days to event here is from the intervention period. | Posted | Mean | Standard Deviation | Days to event | Duration of hospitalization for each patient during 15-month intervention period |
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| Other Pre-specified | ICU Transfers [Safety Outcome 2] | Days from hospital admission until transfer to ICU, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection. | The mean number of days to event here is from the intervention period. | Posted | Mean | Standard Deviation | Days to event | Duration of hospitalization for each patient during 15-month intervention period |
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| Other Pre-specified | Length-of-stay [Safety Outcome 3] | Days from hospital admission until discharge. If the patient remains in the hospital at the end of the trial data collection, the number of days is censored (capped) at that time. Almost all patients will be discharged before the end of trial data collection. | The mean number of days to event here is from the intervention period. | Posted | Mean | Standard Deviation | Days to event | Duration of hospitalization for each patient during 15-month intervention period |
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| Other Pre-specified | Extended-Spectrum Days of Therapy With Inpatient Extended-Spectrum (ES) Antibacterial Treatment After Empiric Period | The summed number of different ES antibacterials received each day, measured repeatedly on or after 4 calendar days of admission and divided by the number of days from hospital day 4 through discharge. Note: this outcome is intended for a secondary manuscript. | Not Posted | 15 month intervention | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Empiric and Total Antibacterial Costs | Empiric and total antibacterial costs during hospitalization. Note: this outcome is intended for a secondary manuscript. | Not Posted | 15 month intervention | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Incidence of Hospital-Onset C. Difficile | Hospital-onset C. difficile positive tests (specimen obtained) after 3 calendar days of admission during hospitalization. Note: this outcome is intended for a secondary manuscript. | Not Posted | 15 month intervention | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Incidence of Hospital-Onset MDRO-Positive Cultures | Newly-detected hospital-onset MDRO-positive cultures (on or after 3 calendar days of admission). Includes total MDRO and specific MDRO subsets. Note: this outcome is intended for a secondary manuscript. | Not Posted | 15 month intervention | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Fluoroquinolone (FQ) Days of Therapy Per Empiric and Total At-risk Days | The summed number of different fluoroquinolone antibacterials received each day, measured repeatedly over (1) the first three days (empiric) of an admission and divided by the number of days of the admission and (2) all days of an admission divided by the total number of admission days. Note: this outcome is intended for a secondary manuscript. | Not Posted | 15 month intervention | Participants |
15 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Routine Stewardship | Continuation of all antibiotic stewardship activities in accordance with national standards. | 0 | 21,998 | 0 | 21,998 | 0 | 21,998 |
| EG001 | Arm 2: CPOE Bundle | Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for PNA in non-ICU patients in the first 3 days of hospitalization. | 0 | 22,782 | 0 | 22,782 | 0 | 22,782 |
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[Not Specified]
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shruti Gohil, MD, MPH | Division of Infectious Diseases, University of California Irvine School of Medicine | (714) 456-7890 | skgohil@hs.uci.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2020 | May 16, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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