Procalcitonin Use in Pneumonia Patients in the Critical Care Setting
Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01788488
Collaborator
(none)
134
1
2
3.9
34
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
134 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Measuring Serum Procalcitonin Levels on Duration of Antimicrobial Therapy in Critical Care Patients With Suspected Pneumonia
Study Start Date
:
Feb 1, 2013
Actual Primary Completion Date
:
Mar 1, 2013
Actual Study Completion Date
:
Jun 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard Therapy
|
|
| Experimental: Procalcitonin-guided therapy Procalcitonin levels will be measured to determine when it is appropriate to discontinue antibiotic therapy. |
Other: Use of procalcitonin as biomarker to guide therapy
|
Outcome Measures
Primary Outcome Measures
- Length of antibiotic therapy [Indefinite]
Participants will be followed for the entire time they are on antibiotics to treat pneumonia, an expected average of 30 total antibiotic days.
Secondary Outcome Measures
- Length of stay in critical care unit [Indefinite]
Participants will be followed for their entire length of stay in the critical care unit, an expected average of 7 days.
- Cost [Once]
The average cost of antibiotics per patient, measured in US dollars, based on total antibiotic days.
- Length of stay in the hospital [Indefinite]
Participants will be followed their entire length of stay in the hospital, an expected average of 14 days.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic Health System Eau Claire | Eau Claire | Wisconsin | United States | 54702 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Kent Gierhart, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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.
- Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, Schortgen F, Lasocki S, Veber B, Dehoux M, Bernard M, Pasquet B, Régnier 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.
- Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Müller 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.
- Christ-Crain M, Stolz D, Bingisser R, Müller C, Miedinger D, Huber PR, Zimmerli W, Harbarth S, Tamm M, Müller 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. Epub 2006 Apr 7.
- 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. Review.
- 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. Review.
- 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.
- 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. Review.
- 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. Review.
- 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:S27-72.
- 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. Review.
- 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. Review.
- 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. Review.
- 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.
Responsible Party:
Kent H. Gierhart,
PI,
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01788488
Other Study ID Numbers:
- 12-008835
First Posted:
Feb 11, 2013
Last Update Posted:
Jun 25, 2013
Last Verified:
Jun 1, 2013
Keywords provided by Kent H. Gierhart,
PI,
Mayo Clinic
Additional relevant MeSH terms: