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To compare and contrast antibiotic use and its effects on patient outcomes before and after the implementation of a PCT protocol in the ICU at Methodist Richardson Medical Center (MRMC).
Based on previous clinical trials, current literature supports the use of PCT levels in combination with clinical assessments to help determine optimal antibiotic therapy. On May 30, 2022, MRMC launched a PCT protocol in the ICU that allows clinical pharmacy specialists to order PCT levels in certain bacterial infections. In order to determine the effects of the protocol, a retrospective quasi-experimental review will be conducted
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| compare antibiotic duration of therapy | Other | To compare antibiotic duration of therapy before and after the implementation of the PCT protocol in the ICU. |
| Measure | Description | Time Frame |
|---|---|---|
| Total days of antibiotic therapy | Actual antibiotic days and predicted antibiotic days (i.e., SAAR) | 6 months |
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Inclusion Criteria:
● Patients aged 18 years or older
Patients being monitored on the PCT protocol
ICU location status for at least part of the admission
Received antibiotics in the ICU for a diagnosis of:
Exclusion Criteria:
Received antibiotics in the ICU for a diagnosis of:
Uncomplicated skin and soft tissue infections
Abscess
Empyema
Bacterial infections that require prolonged antibiotic therapy (e.g., osteomyelitis, endocarditis, tuberculosis, etc.)
Intra-abdominal infection
Urinary tract infection
Bacterial meningitis
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Patients aged 18 years or older Patients being monitored on the PCT protocol
ICU location status for at least part of the admission
Received antibiotics in the ICU for a diagnosis of:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Richow, PharmD | Methodist Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Richardson Medical Center | Dallas | Texas | 75082 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33734417 | Background | Magill SS, O'Leary E, Ray SM, Kainer MA, Evans C, Bamberg WM, Johnston H, Janelle SJ, Oyewumi T, Lynfield R, Rainbow J, Warnke L, Nadle J, Thompson DL, Sharmin S, Pierce R, Zhang AY, Ocampo V, Maloney M, Greissman S, Wilson LE, Dumyati G, Edwards JR, Chea N, Neuhauser MM; Emerging Infections Program Hospital Prevalence Survey Team. Assessment of the Appropriateness of Antimicrobial Use in US Hospitals. JAMA Netw Open. 2021 Mar 1;4(3):e212007. doi: 10.1001/jamanetworkopen.2021.2007. | |
| 30126572 |
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All information will be blinded in compliance with GCP. The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of PHI or research information. Only de-identified PHI will be shared in relevant research mediums. Data obtained from this research will be presented at the Texas Society of Health-System Pharmacists 2023 Alcalde Annual Seminar. The conference will be held on April 21st-23rd, 2023. Data obtained from this research will also be written in manuscript format and submitted to a peer-reviewed journal.
1 year
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| Background |
| Rice LB. Antimicrobial Stewardship and Antimicrobial Resistance. Med Clin North Am. 2018 Sep;102(5):805-818. doi: 10.1016/j.mcna.2018.04.004. Epub 2018 Jul 14. |
| 15070906 | Background | Becker KL, Nylen ES, White JC, Muller B, Snider RH Jr. Clinical review 167: Procalcitonin and the calcitonin gene family of peptides in inflammation, infection, and sepsis: a journey from calcitonin back to its precursors. J Clin Endocrinol Metab. 2004 Apr;89(4):1512-25. doi: 10.1210/jc.2002-021444. No abstract available. |
| 21936959 | Background | Schuetz P, Albrich W, Mueller B. Procalcitonin for diagnosis of infection and guide to antibiotic decisions: past, present and future. BMC Med. 2011 Sep 22;9:107. doi: 10.1186/1741-7015-9-107. |
| 20097417 | Background | Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, Schortgen F, Lasocki S, Veber B, Dehoux M, Bernard M, Pasquet B, Regnier B, Brun-Buisson C, Chastre J, Wolff M; PRORATA trial group. Use of procalcitonin to reduce patients' exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet. 2010 Feb 6;375(9713):463-74. doi: 10.1016/S0140-6736(09)61879-1. Epub 2010 Jan 25. |
| 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. |
| 26947523 | Background | de Jong E, van Oers JA, Beishuizen A, Vos P, Vermeijden WJ, Haas LE, Loef BG, Dormans T, van Melsen GC, Kluiters YC, Kemperman H, van den Elsen MJ, Schouten JA, Streefkerk JO, Krabbe HG, Kieft H, Kluge GH, van Dam VC, van Pelt J, Bormans L, Otten MB, Reidinga AC, Endeman H, Twisk JW, van de Garde EMW, de Smet AMGA, Kesecioglu J, Girbes AR, Nijsten MW, de Lange DW. Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Lancet Infect Dis. 2016 Jul;16(7):819-827. doi: 10.1016/S1473-3099(16)00053-0. Epub 2016 Mar 2. |
| 24598596 | Result | Fridkin S, Baggs J, Fagan R, Magill S, Pollack LA, Malpiedi P, Slayton R, Khader K, Rubin MA, Jones M, Samore MH, Dumyati G, Dodds-Ashley E, Meek J, Yousey-Hindes K, Jernigan J, Shehab N, Herrera R, McDonald CL, Schneider A, Srinivasan A; Centers for Disease Control and Prevention (CDC). Vital signs: improving antibiotic use among hospitalized patients. MMWR Morb Mortal Wkly Rep. 2014 Mar 7;63(9):194-200. |