Procalcitonin Protocol Use to Guide Antibiotic Therapy Duration in the Intensive Care Unit

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Comparing Antibiotic Duration of Therapy
• Intervention / Treatment: Other: compare antibiotic duration of therapy

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 208

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75082
      • Methodist Richardson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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:

  • Community-acquired pneumonia
  • Hospital-acquired pneumonia
  • Ventilator-associated pneumonia
  • Sepsis and/or septic shock
  • Uncomplicated bacteremia with known source
  • Chronic obstructive pulmonary disorder exacerbation
  • Asthma exacerbation

Description

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:

    • Community-acquired pneumonia
    • Hospital-acquired pneumonia
    • Ventilator-associated pneumonia
    • Sepsis and/or septic shock
    • Uncomplicated bacteremia with known source
    • Chronic obstructive pulmonary disorder exacerbation
    • Asthma exacerbation

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

    • Estimated Glomerular Filtration Rate <15 mL/min
    • Requiring renal replacement therapy
    • Status post cardiac arrest/target temperature management

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total days of antibiotic therapy	Actual antibiotic days and predicted antibiotic days (i.e., SAAR)	6 months

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Wendy Richow, PharmD, Methodist Health System

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: JAMA Netw Open. 2021 Apr 1;4(4):e219526.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Estimated): November 29, 2024
• Study Completion (Estimated): November 29, 2024

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 117.PHA.2022.R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No