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

NCT ID: NCT05756049

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-29

Study Completion Date

2024-11-29

Brief Summary

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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).

Detailed Description

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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

Conditions

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Comparing Antibiotic Duration of Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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compare antibiotic duration of therapy

To compare antibiotic duration of therapy before and after the implementation of the PCT protocol in the ICU.

Intervention Type OTHER

Eligibility Criteria

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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:

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy Richow, PharmD

Role: PRINCIPAL_INVESTIGATOR

Methodist Health System

Locations

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Methodist Richardson Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 33734417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30126572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15070906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21936959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20097417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19738090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26947523 (View on PubMed)

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.

Reference Type RESULT
PMID: 24598596 (View on PubMed)

Other Identifiers

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117.PHA.2022.R

Identifier Type: -

Identifier Source: org_study_id

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