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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01GM101197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
| BioMérieux | INDUSTRY |
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The ProACT study is a 5 year, multicenter study that will test the effect of implementation of a novel procalcitonin guideline on antibiotic use and adverse outcomes in Emergency Department (ED) patients with Lower Respiratory Tract Infection (LRTI).
There is a need for improved decision-making for antibiotic prescription in acute suspected infection. Infections, particularly in the early stages, can have protean manifestations, often do not manifest with "classic" signs, and clinically overlap with non-infectious conditions. However, the imperative to quickly give antibiotics for bacterial infection has led to antibiotic overuse and resistance.
Strategies that combine novel diagnostics with therapeutics have improved decision-making in oncology, cardiology, and other fields. These strategies aim to identify those patients most likely to be helped or harmed by the therapeutic intervention and allow more individualized care. This approach takes diagnostics to the next level, by demanding a test not only measure well, but also that clinical care be improved by tying the test to a treatment strategy.
Procalcitonin, a novel biomarker of bacterial infection, may help physicians make more appropriate antibiotic decisions. Lower respiratory tract infection (LRTI) is an ideal trial population. LRTI accounts for a large proportion of antibiotic prescription, and exemplifies the imprecise clinical phenotype of infection.However, key questions of generalizability and safety preclude widespread application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procalcitonin (PCT) group | Experimental | Procalcitonin (PCT) level; Results of procalcitonin level to treating clinician; Provide procalcitonin guideline to treating clinician; Telephone Visit at Day 15 and Day 30 |
|
| Usual Care group | Active Comparator | Telephone Visit at Day 15 and Day 30 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procalcitonin level | Other | A procalcitonin (PCT) will be drawn level within one hour after randomization in the ED, and if hospitalized, 6-24 hours after the initial ED blood draw, and on Days 3, 5, and 7. Days 3, 5, and 7 blood draws for procalcitonin will only occur in hospitalized patients on antibiotics and/or at the treating physician's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Antibiotic Exposure Days | Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30. | 30 days |
| Number of Participants With Any Adverse Outcome | Primary Safety Outcome - Combined endpoint of adverse outcomes (death, endotracheal intubation, vasopressors, renal failure, lung abscess/empyema, pneumonia in non-CAP patient, and hospital readmissions) that could be attributable to withholding antibiotics in lower respiratory tract infection (LRTI). Number is based on the number of participants that experienced any adverse outcome. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic Prescription in Emergency Department(ED) | Antibiotic prescription in the ED includes post-randomization receipt of antibiotics in ED and provision of an antibiotic prescription for patients at the time of discharge from the ED. | While in the ED or before ED discharge (majority patients < 1 day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David T Huang, MD MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Maricopa Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16175035 | Background | Meisner M. Biomarkers of sepsis: clinically useful? Curr Opin Crit Care. 2005 Oct;11(5):473-80. doi: 10.1097/01.ccx.0000176694.92883.ce. | |
| 19529989 | Background | Schuetz P, Christ-Crain M, Muller B. Procalcitonin and other biomarkers to improve assessment and antibiotic stewardship in infections--hope for hype? Swiss Med Wkly. 2009 Jun 13;139(23-24):318-26. doi: 10.4414/smw.2009.12584. |
Not provided
Not provided
Only 8 patients (4 in each arm) were entirely excluded because they withdrew all consent to participate.
Subjects were enrolled in the Emergency Department (ED) if they had a primary clinical diagnosis of acute Lower Respiratory Tract Infection [LRTI] (< 28 days duration) and their key clinician was willing to consider Procalcitonin (PCT) result in Antibiotic (ABX) decision making.
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| ID | Title | Description |
|---|---|---|
| FG000 | Procalcitonin (PCT) Group | Procalcitonin (PCT) Results of procalcitonin level provided to treating clinician (initial in the ED, 6-24 hrs after initial. and Day 3, 5, 7 if in hospital AND on abx or at the treating clinician's discretion) Telephone Visit at Day 15 and Day 30 to collect ABX days, post-d/c resource use and AQ-20 questionnaire Bio-bank samples collected in ED for storage at Coordinating Center |
| 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_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Mar 8, 2017 |
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|
|
| Results of procalcitonin (PCT) level to treating clinician | Other | In the ED, we will quickly (<1 hour goal) provide clinicians the procalcitonin result. |
|
| Provide procalcitonin guideline to treating clinician | Other | Procalcitonin antibiotic guideline -- Procalcitonin level (ug/L) -- Bacterial etiology -- Recommendation < 0.1 -- Very unlikely -- Antibiotics strongly discouraged(1) 0.1 - 0.25 -- Unlikely -- Antibiotics discouraged(1) > 0.25 - 0.5 -- Likely -- Antibiotics recommended(2) > 0.5 -- Very likely -- Antibiotics strongly recommended(2)
|
|
| Telephone Visit | Other | We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30 |
|
| Phoenix |
| Arizona |
| 85008 |
| United States |
| University of California at Irvine Medical Center | Orange | California | 92868 | United States |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| University of Maryland/Baltimore | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Wayne State University/Detroit Receiving Hospital | Detroit | Michigan | 48201 | United States |
| Essentia Institute of Rural Health | Duluth | Minnesota | 55805 | United States |
| The Ohio State University, College of Medicine | Columbus | Ohio | 43210 | United States |
| Penn State Hershey College of Medicine; Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | United States |
| 11232031 | Background | Muller B, White JC, Nylen ES, Snider RH, Becker KL, Habener JF. Ubiquitous expression of the calcitonin-i gene in multiple tissues in response to sepsis. J Clin Endocrinol Metab. 2001 Jan;86(1):396-404. doi: 10.1210/jcem.86.1.7089. |
| 12627371 | Background | Nylen E, Muller B, Becker KL, Snider R. The future diagnostic role of procalcitonin levels: the need for improved sensitivity. Clin Infect Dis. 2003 Mar 15;36(6):823-4; author reply 826-7. doi: 10.1086/368088. No abstract available. |
| 16715031 | Background | Uzzan B, Cohen R, Nicolas P, Cucherat M, Perret GY. Procalcitonin as a diagnostic test for sepsis in critically ill adults and after surgery or trauma: a systematic review and meta-analysis. Crit Care Med. 2006 Jul;34(7):1996-2003. doi: 10.1097/01.CCM.0000226413.54364.36. |
| 17161501 | Background | Jones AE, Fiechtl JF, Brown MD, Ballew JJ, Kline JA. Procalcitonin test in the diagnosis of bacteremia: a meta-analysis. Ann Emerg Med. 2007 Jul;50(1):34-41. doi: 10.1016/j.annemergmed.2006.10.020. Epub 2006 Dec 11. |
| 15307030 | Background | Simon L, Gauvin F, Amre DK, Saint-Louis P, Lacroix J. Serum procalcitonin and C-reactive protein levels as markers of bacterial infection: a systematic review and meta-analysis. Clin Infect Dis. 2004 Jul 15;39(2):206-17. doi: 10.1086/421997. Epub 2004 Jul 2. |
| 16862463 | Background | Stolz D, Christ-Crain M, Gencay MM, Bingisser R, Huber PR, Muller B, Tamm M. Diagnostic value of signs, symptoms and laboratory values in lower respiratory tract infection. Swiss Med Wkly. 2006 Jul 8;136(27-28):434-40. doi: 10.4414/smw.2006.11271. |
| 18329217 | Background | Hirakata Y, Yanagihara K, Kurihara S, Izumikawa K, Seki M, Miyazaki Y, Kohno S. Comparison of usefulness of plasma procalcitonin and C-reactive protein measurements for estimation of severity in adults with community-acquired pneumonia. Diagn Microbiol Infect Dis. 2008 Jun;61(2):170-4. doi: 10.1016/j.diagmicrobio.2008.01.014. Epub 2008 Mar 7. |
| 18839468 | Background | Prieto B, Llorente E, Gonzalez-Pinto I, Alvarez FV. Plasma procalcitonin measured by time-resolved amplified cryptate emission (TRACE) in liver transplant patients. A prognosis marker of early infectious and non-infectious postoperative complications. Clin Chem Lab Med. 2008;46(5):660-6. doi: 10.1515/cclm.2008.123. |
| 18661397 | Background | Prat C, Sancho JM, Dominguez J, Xicoy B, Gimenez M, Ferra C, Blanco S, Lacoma A, Ribera JM, Ausina V. Evaluation of procalcitonin, neopterin, C-reactive protein, IL-6 and IL-8 as a diagnostic marker of infection in patients with febrile neutropenia. Leuk Lymphoma. 2008 Sep;49(9):1752-61. doi: 10.1080/10428190802258956. |
| 19386110 | Background | Charles PE, Kus E, Aho S, Prin S, Doise JM, Olsson NO, Blettery B, Quenot JP. Serum procalcitonin for the early recognition of nosocomial infection in the critically ill patients: a preliminary report. BMC Infect Dis. 2009 Apr 22;9:49. doi: 10.1186/1471-2334-9-49. |
| 18342993 | Background | Huang DT, Weissfeld LA, Kellum JA, Yealy DM, Kong L, Martino M, Angus DC; GenIMS Investigators. Risk prediction with procalcitonin and clinical rules in community-acquired pneumonia. Ann Emerg Med. 2008 Jul;52(1):48-58.e2. doi: 10.1016/j.annemergmed.2008.01.003. Epub 2008 Mar 17. |
| 17335562 | Background | Muller B, Harbarth S, Stolz D, Bingisser R, Mueller C, Leuppi J, Nusbaumer C, Tamm M, Christ-Crain M. Diagnostic and prognostic accuracy of clinical and laboratory parameters in community-acquired pneumonia. BMC Infect Dis. 2007 Mar 2;7:10. doi: 10.1186/1471-2334-7-10. |
| 21369807 | Background | Cuquemelle E, Soulis F, Villers D, Roche-Campo F, Ara Somohano C, Fartoukh M, Kouatchet A, Mourvillier B, Dellamonica J, Picard W, Schmidt M, Boulain T, Brun-Buisson C; A/H1N1 REVA-SRLF Study Group. Can procalcitonin help identify associated bacterial infection in patients with severe influenza pneumonia? A multicentre study. Intensive Care Med. 2011 May;37(5):796-800. doi: 10.1007/s00134-011-2189-1. Epub 2011 Mar 3. |
| 21614897 | Background | Schappert SM, Rechtsteiner EA. Ambulatory medical care utilization estimates for 2007. Vital Health Stat 13. 2011 Apr;(169):1-38. |
| 14987884 | Background | Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7. doi: 10.1016/S0140-6736(04)15591-8. |
| 17218551 | Background | Stolz D, Christ-Crain M, Bingisser R, Leuppi J, Miedinger D, Muller C, Huber P, Muller B, Tamm M. Antibiotic treatment of exacerbations of COPD: a randomized, controlled trial comparing procalcitonin-guidance with standard therapy. Chest. 2007 Jan;131(1):9-19. doi: 10.1378/chest.06-1500. |
| 19738090 | Background | Schuetz P, Christ-Crain M, Thomann R, Falconnier C, Wolbers M, Widmer I, Neidert S, Fricker T, Blum C, Schild U, Regez K, Schoenenberger R, Henzen C, Bregenzer T, Hoess C, Krause M, Bucher HC, Zimmerli W, Mueller B; ProHOSP Study Group. Effect of procalcitonin-based guidelines vs standard guidelines on antibiotic use in lower respiratory tract infections: the ProHOSP randomized controlled trial. JAMA. 2009 Sep 9;302(10):1059-66. doi: 10.1001/jama.2009.1297. |
| 21507143 | Background | Long W, Deng X, Zhang Y, Lu G, Xie J, Tang J. Procalcitonin guidance for reduction of antibiotic use in low-risk outpatients with community-acquired pneumonia. Respirology. 2011 Jul;16(5):819-24. doi: 10.1111/j.1440-1843.2011.01978.x. |
| 36658543 | Derived | Malley BE, Yabes JG, Gimbel E, Chang CH, Yealy DM, Fine MJ, Angus DC, Huang DT; ProACT Investigators. Impact of adherence to procalcitonin antibiotic prescribing guideline recommendations for low procalcitonin levels on antibiotic use. BMC Infect Dis. 2023 Jan 19;23(1):30. doi: 10.1186/s12879-022-07923-0. |
| 29781385 | Derived | Huang DT, Yealy DM, Filbin MR, Brown AM, Chang CH, Doi Y, Donnino MW, Fine J, Fine MJ, Fischer MA, Holst JM, Hou PC, Kellum JA, Khan F, Kurz MC, Lotfipour S, LoVecchio F, Peck-Palmer OM, Pike F, Prunty H, Sherwin RL, Southerland L, Terndrup T, Weissfeld LA, Yabes J, Angus DC; ProACT Investigators. Procalcitonin-Guided Use of Antibiotics for Lower Respiratory Tract Infection. N Engl J Med. 2018 Jul 19;379(3):236-249. doi: 10.1056/NEJMoa1802670. Epub 2018 May 20. |
| 28851296 | Derived | Huang DT, Angus DC, Chang CH, Doi Y, Fine MJ, Kellum JA, Peck-Palmer OM, Pike F, Weissfeld LA, Yabes J, Yealy DM; ProACT Investigators. Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection. BMC Emerg Med. 2017 Aug 29;17(1):25. doi: 10.1186/s12873-017-0138-1. |
| FG001 | Usual Care (UC) Group | Usual Care Telephone Visit at Day 15 and Day 30 to collect ABX days, post-d/c resource use and AQ-20 questionnaire Bio-bank samples collected in ED for storage at Coordinating Center |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Only excluded 4 patients in each group for a total of 8 subjects. These 8 subjects withdrew all consent for participation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Procalcitonin (PCT) Group | Procalcitonin level: A procalcitonin (PCT) will be drawn level within one hour after randomization in the ED, and if hospitalized, 6-24 hours after the initial ED blood draw, and on Days 3, 5, and 7. Days 3, 5, and 7 blood draws for procalcitonin will only occur in hospitalized patients on antibiotics and/or at the treating physician's discretion. Results of procalcitonin (PCT) level to treating clinician: In the ED, we will quickly (<1 hour goal) provide clinicians the procalcitonin result. Provide PCT guideline to treating clinician: Procalcitonin antibiotic guideline -- PCT level (ug/L)-- Bacterial etiology -- Recommendation < 0.1-- Very unlikely -- Antibiotics strongly discouraged 0.1 - 0.25 -- Unlikely--Antibiotics discouraged > 0.25 - 0.5--Likely -- Antibiotics recommended > 0.5-- Very likely -- Antibiotics strongly recommended Telephone Visit: We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30 |
| BG001 | Usual Care (UC) Group | Telephone Visit at Day 15 and Day 30 Telephone Visit: We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30 |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Ethnicity was self-reported and information was requested prior to race description | Race and ethnic group were reported by the patients. | Count of Participants | Participants |
| ||||||||||||||
| Region of Enrollment | Number | 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 | Total Antibiotic Exposure Days | Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30. | Mixed modeling was used to impute missing data for the intention-to-treat analysis for the primary outcome since not all patients could be reached for the 30 day interview (which collected 30 day antibiotic use). | Posted | Mean | Standard Deviation | days | 30 days |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Any Adverse Outcome | Primary Safety Outcome - Combined endpoint of adverse outcomes (death, endotracheal intubation, vasopressors, renal failure, lung abscess/empyema, pneumonia in non-CAP patient, and hospital readmissions) that could be attributable to withholding antibiotics in lower respiratory tract infection (LRTI). Number is based on the number of participants that experienced any adverse outcome. | Posted | Count of Participants | Participants | 30 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Antibiotic Prescription in Emergency Department(ED) | Antibiotic prescription in the ED includes post-randomization receipt of antibiotics in ED and provision of an antibiotic prescription for patients at the time of discharge from the ED. | Posted | Count of Participants | Participants | While in the ED or before ED discharge (majority patients < 1 day) |
|
By day 30.
All events were reviewed and assessed by the Principal Investigator at the participating site.
8 patients (4 in each arm) were entirely excluded because they withdrew all consent to participate.
Most specific terms are reported in the Adverse Event Section.
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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 | Procalcitonin (PCT) Group | Procalcitonin (PCT) Results of procalcitonin level provided to treating clinician (initial in the ED, 6-24 hrs after initial. and Day 3, 5, 7 if in hospital AND on abx or at the treating clinician's discretion) Telephone Visit at Day 15 and Day 30 to collect ABX days, post-d/c resource use and AQ-20 questionnaire Bio-bank samples collected in ED for storage at Coordinating Center | 16 | 826 | 14 | 826 | 20 | 826 |
| EG001 | Usual Care Group | Usual Care Telephone Visit at Day 15 and Day 30 to collect ABX days, post-d/c resource use and AQ-20 questionnaire Bio-bank samples collected in ED for storage at Coordinating Center | 10 | 830 | 9 | 830 | 14 | 830 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Death NOS | General disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE Version 4.03 | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Immune system disorders | Immune system disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | CTCAE Version 4.03 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment | Patient developed pseudomonas PNA while in hospital |
|
| Heart failure | Cardiac disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE Version 4.03 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment | No descriptions |
|
| Death NOS | General disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE Version 4.03 | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Allergic reaction | Immune system disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Intraoperative musculoskeletal injury | Injury, poisoning and procedural complications | CTCAE Version 4.03 | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Pain | General disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | CTCAE Version 4.03 | Systematic Assessment |
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| Sinusitis | Infections and infestations | CTCAE Version 4.03 | Systematic Assessment |
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| Wound infection | Infections and infestations | CTCAE Version 4.03 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Radiculitis | Nervous system disorders | CTCAE Version 4.03 | Systematic Assessment |
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| Syncope | Nervous system disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Bronchial stricture | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE Version 4.03 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David T Huang, MD, MPH, Associate Professor | University of Pittsburgh | 412-647-6818 | huangdt@upmc.edu |
| Jan 11, 2019 |
| Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2017 | Jan 11, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077740 | Procalcitonin |
| ID | Term |
|---|---|
| D002116 | Calcitonin |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D011506 | Proteins |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Black |
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