NCT03711227

Brief Summary

Procalcitonin levels checked initially and at 24 hours will correlate with disease severity, morbidity, and mortality. Patients who have a higher procalcitonin level initially and at 24 hours will likely have higher qSOFA scores, longer lengths of stay, longer duration of antibiotics and higher 30 day mortality rates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 17, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

November 29, 2024

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

June 2, 2018

Last Update Submit

November 26, 2024

Conditions

Keywords

Serial Procalcitonin, Admitted Pneumonia, qSOFA, Sepsis

Outcome Measures

Primary Outcomes (1)

  • Change in Procalcitonin level

    Change in procalcitonin level in the blood serum

    Measured at baseline and at 24 hours

Secondary Outcomes (4)

  • qSOFA score

    baseline and at 24 hours

  • Length of stay

    an average of 30 days

  • Duration of antibiotics

    an average of 30 days

  • 30 Day Mortality

    30 days

Study Arms (1)

Procalcitonin lab test

A procalcitonin order bundle will be created for admitted patients with pneumonia. This prepopulated bundle includes an initial and 24 hour procalcitonin level. These patients will receive treatment for their pneumonia as is deemed appropriate by their care teams, both in the Emergency Department and while an inpatient. Then, after discharge, the 30 day mortality, length of stay, choice of antibiotic therapy, and qSOFA score (which will be retroactively calculated) will be compared to the patient's initial and 24 hour procalcitonin level.

Diagnostic Test: Procalcitonin lab test

Interventions

Procalcitonin lab testDIAGNOSTIC_TEST

A procalcitonin order bundle will be created for admitted patients with pneumonia. This prepopulated bundle includes an initial and 24 hour procalcitonin level.

Procalcitonin lab test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients seen at Lakeland St. Joseph and Niles Hospitals in the emergency department and who are then subsequently admitted with pneumonia at Lakeland St. Joseph and Niles Hospitals

You may qualify if:

  • All patients seen at Lakeland St. Joseph and Niles Hospitals in the emergency department and who are then subsequently admitted with pneumonia at Lakeland St. Joseph and Niles Hospitals

You may not qualify if:

  • Any patients not admitted with pneumonia, any patients who are admitted with another primary diagnosis other than pneumonia, any patients who do not have an initial or 24 hour procalcitonin level result, and any patients less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lakeland Regional Healthcare

Saint Joseph, Michigan, 49085, United States

Location

Related Publications (22)

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    PMID: 21385367BACKGROUND
  • Boussekey N, Leroy O, Alfandari S, Devos P, Georges H, Guery B. Procalcitonin kinetics in the prognosis of severe community-acquired pneumonia. Intensive Care Med. 2006 Mar;32(3):469-72. doi: 10.1007/s00134-005-0047-8. Epub 2006 Feb 14.

    PMID: 16477418BACKGROUND
  • Chan YL, Tseng CP, Tsay PK, Chang SS, Chiu TF, Chen JC. Procalcitonin as a marker of bacterial infection in the emergency department: an observational study. Crit Care. 2004 Feb;8(1):R12-20. doi: 10.1186/cc2396. Epub 2003 Nov 20.

    PMID: 14975050BACKGROUND
  • Christ-Crain M, Muller B. Procalcitonin and pneumonia: is it a useful marker? Curr Infect Dis Rep. 2007 May;9(3):233-40. doi: 10.1007/s11908-007-0037-9.

    PMID: 17430706BACKGROUND
  • Garnacho-Montero J, Huici-Moreno MJ, Gutierrez-Pizarraya A, Lopez I, Marquez-Vacaro JA, Macher H, Guerrero JM, Puppo-Moreno A. Prognostic and diagnostic value of eosinopenia, C-reactive protein, procalcitonin, and circulating cell-free DNA in critically ill patients admitted with suspicion of sepsis. Crit Care. 2014 Jun 5;18(3):R116. doi: 10.1186/cc13908.

    PMID: 24903083BACKGROUND
  • Hicks CW, Engineer RS, Benoit JL, Dasarathy S, Christenson RH, Peacock WF. Procalcitonin as a biomarker for early sepsis in the emergency department. Eur J Emerg Med. 2014 Apr;21(2):112-7. doi: 10.1097/MEJ.0b013e328361fee2.

    PMID: 23669296BACKGROUND
  • Huang DT, Weissfeld LA, Kellum JA, Yealy DM, Kong L, Martino M, Angus DC; GenIMS Investigators. Risk prediction with procalcitonin and clinical rules in community-acquired pneumonia. Ann Emerg Med. 2008 Jul;52(1):48-58.e2. doi: 10.1016/j.annemergmed.2008.01.003. Epub 2008 Mar 17.

    PMID: 18342993BACKGROUND
  • Kim SY, Jeong TD, Lee W, Chun S, Min WK. Procalcitonin in the assessment of bacteraemia in emergency department patients: results of a large retrospective study. Ann Clin Biochem. 2015 Nov;52(Pt 6):654-9. doi: 10.1177/0004563214568685. Epub 2015 Jan 9.

    PMID: 25575698BACKGROUND
  • Le Bel J, Hausfater P, Chenevier-Gobeaux C, Blanc FX, Benjoar M, Ficko C, Ray P, Choquet C, Duval X, Claessens YE; ESCAPED study group. Diagnostic accuracy of C-reactive protein and procalcitonin in suspected community-acquired pneumonia adults visiting emergency department and having a systematic thoracic CT scan. Crit Care. 2015 Oct 16;19:366. doi: 10.1186/s13054-015-1083-6.

    PMID: 26472401BACKGROUND
  • Lipinska-Gediga M, Mierzchala-Pasierb M, Durek G. Procalcitonin kinetics - prognostic and diagnostic significance in septic patients. Arch Med Sci. 2016 Feb 1;12(1):112-9. doi: 10.5114/aoms.2016.57587. Epub 2016 Feb 2.

    PMID: 26925126BACKGROUND
  • Liu D, Su LX, Guan W, Xiao K, Xie LX. Prognostic value of procalcitonin in pneumonia: A systematic review and meta-analysis. Respirology. 2016 Feb;21(2):280-8. doi: 10.1111/resp.12704. Epub 2015 Dec 10.

    PMID: 26662169BACKGROUND
  • Masia M, Gutierrez F, Shum C, Padilla S, Navarro JC, Flores E, Hernandez I. Usefulness of procalcitonin levels in community-acquired pneumonia according to the patients outcome research team pneumonia severity index. Chest. 2005 Oct;128(4):2223-9. doi: 10.1378/chest.128.4.2223.

    PMID: 16236878BACKGROUND
  • Meisner M, Tschaikowsky K, Palmaers T, Schmidt J. Comparison of procalcitonin (PCT) and C-reactive protein (CRP) plasma concentrations at different SOFA scores during the course of sepsis and MODS. Crit Care. 1999;3(1):45-50. doi: 10.1186/cc306.

    PMID: 11056723BACKGROUND
  • Park JH, Wee JH, Choi SP, Oh SH. The value of procalcitonin level in community-acquired pneumonia in the ED. Am J Emerg Med. 2012 Sep;30(7):1248-54. doi: 10.1016/j.ajem.2011.08.009. Epub 2011 Oct 24.

    PMID: 22030193BACKGROUND
  • Pfister R, Kochanek M, Leygeber T, Brun-Buisson C, Cuquemelle E, Machado MB, Piacentini E, Hammond NE, Ingram PR, Michels G. Procalcitonin for diagnosis of bacterial pneumonia in critically ill patients during 2009 H1N1 influenza pandemic: a prospective cohort study, systematic review and individual patient data meta-analysis. Crit Care. 2014 Mar 10;18(2):R44. doi: 10.1186/cc13760.

    PMID: 24612487BACKGROUND
  • Schuetz P, Amin DN, Greenwald JL. Role of procalcitonin in managing adult patients with respiratory tract infections. Chest. 2012 Apr;141(4):1063-1073. doi: 10.1378/chest.11-2430.

    PMID: 22474148BACKGROUND
  • Schuetz P, Birkhahn R, Sherwin R, Jones AE, Singer A, Kline JA, Runyon MS, Self WH, Courtney DM, Nowak RM, Gaieski DF, Ebmeyer S, Johannes S, Wiemer JC, Schwabe A, Shapiro NI. Serial Procalcitonin Predicts Mortality in Severe Sepsis Patients: Results From the Multicenter Procalcitonin MOnitoring SEpsis (MOSES) Study. Crit Care Med. 2017 May;45(5):781-789. doi: 10.1097/CCM.0000000000002321.

    PMID: 28257335BACKGROUND
  • Schuetz P, Maurer P, Punjabi V, Desai A, Amin DN, Gluck E. Procalcitonin decrease over 72 hours in US critical care units predicts fatal outcome in sepsis patients. Crit Care. 2013 Jun 20;17(3):R115. doi: 10.1186/cc12787.

    PMID: 23787145BACKGROUND
  • Shi Y, Peng JM, Hu XY, Wang Y. The utility of initial procalcitonin and procalcitonin clearance for prediction of bacterial infection and outcome in critically ill patients with autoimmune diseases: a prospective observational study. BMC Anesthesiol. 2015 Oct 7;15:137. doi: 10.1186/s12871-015-0122-9.

    PMID: 26446077BACKGROUND
  • Shomali W, Hachem R, Chaftari AM, Jiang Y, Bahu R, Jabbour J, Raad S, Al Shuaibi M, Al Wohoush I, Raad I. Can procalcitonin distinguish infectious fever from tumor-related fever in non-neutropenic cancer patients? Cancer. 2012 Dec 1;118(23):5823-9. doi: 10.1002/cncr.27602. Epub 2012 May 17.

    PMID: 22605389BACKGROUND
  • Trasy D, Tanczos K, Nemeth M, Hankovszky P, Lovas A, Mikor A, Laszlo I, Hajdu E, Osztroluczki A, Fazakas J, Molnar Z; EProK study group. Early procalcitonin kinetics and appropriateness of empirical antimicrobial therapy in critically ill patients: A prospective observational study. J Crit Care. 2016 Aug;34:50-5. doi: 10.1016/j.jcrc.2016.04.007. Epub 2016 Apr 13.

    PMID: 27288610BACKGROUND
  • Wang XJ, Tan TT, Lim ST, Farid M, Tao M, Quek R, Chan A, Tang T. Role of Procalcitonin in Differentiating between Infectious and Noninfectious Fevers among Patients with Lymphoma. Pharmacotherapy. 2017 Aug;37(8):908-915. doi: 10.1002/phar.1963. Epub 2017 Jul 18.

    PMID: 28556122BACKGROUND

MeSH Terms

Conditions

PneumoniaSepsis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michelino Mancini, DO

    Lakeland Hospitals at St. Joseph and Niles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2018

First Posted

October 18, 2018

Study Start

July 17, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

November 29, 2024

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

No plans to share IPD data

Locations