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PneumoniaNCT03711227

Procalcitonin at Zero and 24 Hours as a Prognostic Factor in Patients With Pneumonia

An observational study of Pneumonia, run by Corewell Health South at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia
What is being tested?
Procalcitonin lab test
How many people
185 participants
Where
1 siteUnited States
Study dates
17 Jul 2018to 1 Aug 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lakeland Regional Healthcare

    Saint Joseph, Michigan, 49085

Other trials in United States

About this study

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.

Read the detailed description

A procalcitonin order bundle will be created for admitted patients with pneumonia. This prepopulated bundle includes an initial and 24 hour procalcitonin level, much like the current initial and 4 hour lactate orders are set-up. 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.

Conditions
Pneumonia
Being tested
Procalcitonin lab test
Keywords
Serial Procalcitonin, Admitted Pneumonia, qSOFA, Sepsis
Medical subject headings
Pneumonia, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03711227
Study groupRoleWhat they receive
Procalcitonin lab testA 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.
Receives: Diagnostic Test: Procalcitonin lab test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Procalcitonin level

    Change in procalcitonin level in the blood serum

    Measured: Measured at baseline and at 24 hours

Secondary outcomes (4)

  1. qSOFA score

    qSOFA score is based on blow blood pressure, high respiratory rate, and altered mental status

    Measured: baseline and at 24 hours

  2. Length of stay

    Length of stay in days, total stay from admission until discharge

    Measured: an average of 30 days

  3. Duration of antibiotics

    Antibiotic treatment length in days

    Measured: an average of 30 days

  4. 30 Day Mortality

    Number of patients who expire vs those alive at 30 days

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2018
  2. Study start17 Jul 2018
  3. Primary completion1 Aug 2019
  4. Study completion1 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03711227
Sponsor's protocol ID
MMMC#1577
Status last verified
Oct 2019
First submitted
2 Jun 2018
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plans to share IPD data

Publications

  • Bloos F, Marshall JC, Dellinger RP, Vincent JL, Gutierrez G, Rivers E, Balk RA, Laterre PF, Angus DC, Reinhart K, Brunkhorst FM. Multinational, observational study of procalcitonin in ICU patients with pneumonia requiring mechanical ventilation: a multicenter observational study. Crit Care. 2011;15(2):R88. doi: 10.1186/cc10087. Epub 2011 Mar 7.

    PubMed 21385367

  • 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.

    PubMed 16477418

  • 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.

    PubMed 14975050

  • 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.

    PubMed 17430706

  • 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.

    PubMed 24903083

  • 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.

    PubMed 23669296

  • 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.

    PubMed 18342993

  • 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.

    PubMed 25575698

  • 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.

    PubMed 26472401

  • 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.

    PubMed 26925126

  • 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.

    PubMed 26662169

  • 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.

    PubMed 16236878

  • 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.

    PubMed 11056723

  • 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.

    PubMed 22030193

  • 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.

    PubMed 24612487

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia, run by Corewell Health South at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Procalcitonin level (time frame: Measured at baseline and at 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03711227, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.

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