Procalcitonin Use in Pneumonia Patients in the Critical Care Setting

NCT ID: NCT01788488

Last Updated: 2013-06-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-06-30

Brief Summary

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The goal of the study is to determine the impact of procalcitonin (PCT)-guided therapy on duration of antibiotic therapy in critical care unit (CCU) patients with suspected pneumonia at Mayo Clinic Health System Eau Claire.

Detailed Description

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Conditions

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Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Procalcitonin-guided therapy

Procalcitonin levels will be measured to determine when it is appropriate to discontinue antibiotic therapy.

Group Type EXPERIMENTAL

Use of procalcitonin as biomarker to guide therapy

Intervention Type OTHER

Interventions

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Use of procalcitonin as biomarker to guide therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years old
* admitted to critical care unit
* placed on pneumonia protocol

Exclusion Criteria

* patients who received outpatient antibiotic therapy within previous 21 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kent H. Gierhart

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kent Gierhart

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Health System Eau Claire

Eau Claire, Wisconsin, United States

Site Status

Countries

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United States

References

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Stolz D, Smyrnios N, Eggimann P, Pargger H, Thakkar N, Siegemund M, Marsch S, Azzola A, Rakic J, Mueller B, Tamm M. Procalcitonin for reduced antibiotic exposure in ventilator-associated pneumonia: a randomised study. Eur Respir J. 2009 Dec;34(6):1364-75. doi: 10.1183/09031936.00053209. Epub 2009 Sep 24.

Reference Type BACKGROUND
PMID: 19797133 (View on PubMed)

Rice LB. The Maxwell Finland Lecture: for the duration-rational antibiotic administration in an era of antimicrobial resistance and clostridium difficile. Clin Infect Dis. 2008 Feb 15;46(4):491-6. doi: 10.1086/526535.

Reference Type BACKGROUND
PMID: 18194098 (View on PubMed)

Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available.

Reference Type BACKGROUND
PMID: 17278083 (View on PubMed)

American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.

Reference Type BACKGROUND
PMID: 15699079 (View on PubMed)

Christ-Crain M, Stolz D, Bingisser R, Muller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Muller B. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006 Jul 1;174(1):84-93. doi: 10.1164/rccm.200512-1922OC. Epub 2006 Apr 7.

Reference Type BACKGROUND
PMID: 16603606 (View on PubMed)

Heyland DK, Johnson AP, Reynolds SC, Muscedere J. Procalcitonin for reduced antibiotic exposure in the critical care setting: a systematic review and an economic evaluation. Crit Care Med. 2011 Jul;39(7):1792-9. doi: 10.1097/CCM.0b013e31821201a5.

Reference Type BACKGROUND
PMID: 21358400 (View on PubMed)

Agarwal R, Schwartz DN. Procalcitonin to guide duration of antimicrobial therapy in intensive care units: a systematic review. Clin Infect Dis. 2011 Aug;53(4):379-87. doi: 10.1093/cid/cir408.

Reference Type BACKGROUND
PMID: 21810753 (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)

Schuetz P, Chiappa V, Briel M, Greenwald JL. Procalcitonin algorithms for antibiotic therapy decisions: a systematic review of randomized controlled trials and recommendations for clinical algorithms. Arch Intern Med. 2011 Aug 8;171(15):1322-31. doi: 10.1001/archinternmed.2011.318.

Reference Type BACKGROUND
PMID: 21824946 (View on PubMed)

Hayashi Y, Paterson DL. Strategies for reduction in duration of antibiotic use in hospitalized patients. Clin Infect Dis. 2011 May;52(10):1232-40. doi: 10.1093/cid/cir063.

Reference Type BACKGROUND
PMID: 21507920 (View on PubMed)

Kook JL, Chao SR, Le J, Robinson PA. Impact of the use of procalcitonin assay in hospitalized adult patients with pneumonia at a community acute care hospital. Infect Control Hosp Epidemiol. 2012 Apr;33(4):424-6. doi: 10.1086/664764.

Reference Type BACKGROUND
PMID: 22418643 (View on PubMed)

Kopterides P, Siempos II, Tsangaris I, Tsantes A, Armaganidis A. Procalcitonin-guided algorithms of antibiotic therapy in the intensive care unit: a systematic review and meta-analysis of randomized controlled trials. Crit Care Med. 2010 Nov;38(11):2229-41. doi: 10.1097/CCM.0b013e3181f17bf9.

Reference Type BACKGROUND
PMID: 20729729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14987884 (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)

Li H, Luo YF, Blackwell TS, Xie CM. Meta-analysis and systematic review of procalcitonin-guided therapy in respiratory tract infections. Antimicrob Agents Chemother. 2011 Dec;55(12):5900-6. doi: 10.1128/AAC.00335-11. Epub 2011 Sep 26.

Reference Type BACKGROUND
PMID: 21947386 (View on PubMed)

Other Identifiers

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12-008835

Identifier Type: -

Identifier Source: org_study_id

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