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ProcalcitoninNCT07770334

Procalcitonin as a Prognostic Predictor in Patients With Acute Infectious Disease Hospitalized in the Internal Medicine Department.

An observational study of Procalcitonin and Infection, run by Barzilai Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Procalcitonin is a well-known biomarker used to distinguish between bacterial and viral infections, assess a patient's risk category, and serve as a prognostic indicator. However, existing data are derived primarily from relatively young patients in intensive care units; there is a lack of information regarding the… Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,000 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 hospitalized in internal medicine and geriatric wards with a diagnosis of acute infectious disease who underwent procalcitonin testing, starting in 2020.

Who may be able to join

  • All patients hospitalized in internal medicine and geriatric wards with a diagnosis of acute infectious disease who underwent procalcitonin testing, starting in 2020.

Who cannot join

  • Age under 18
  • Causes for false positive elevated cacitonin:
  • Extensive burns
  • Major operation in the last 30 days
  • Major trauma in the last 30 days.
  • Severe pancreatitis
Show all 9Show fewer
  • Cardiogenic shock
  • Small Cell Lung Cancer
  • Thyroid gland malignancy

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Daniel Leshin Carmel Head of Infection Prevention and Control, MD contact

+972525253037

danielles@bmc.gov.il

Pnina Nir contact

pninan@bmc.gov.il

About this study

Procalcitonin is a well-known biomarker used to distinguish between bacterial and viral infections, assess a patient's risk category, and serve as a prognostic indicator. However, existing data are derived primarily from relatively young patients in intensive care units; there is a lack of information regarding the prognostic significance of procalcitonin in older patients hospitalized in internal medicine wards.

Read the detailed description

Procalcitonin is a biomarker used to distinguish between bacterial and viral infections, as well as to determine a patient's risk category and serve as a prognostic indicator. Furthermore, monitoring procalcitonin levels and analysing their kinetics during hospitalization improves the management of patients with sepsis and informs decision-making regarding antibiotic use. A wide range of studies has evaluated the diagnostic yield of procalcitonin in sepsis patients, demonstrating its superiority over CRP. However, the studies examined intensive care patients, trauma patients, surgical patients, or relatively young patients (mean age 69). There is significant heterogeneity among the studies, and they do not reach a definitive conclusion: some show an association between high procalcitonin levels and mortality, while others indicate that procalcitonin lacks independent prognostic value. Consequently, there is a significant gap in existing knowledge regarding the value of procalcitonin in a "real-life" setting-specifically, among elderly patients (over age 70) hospitalized in internal medicine wards. The investigators will identify all patients who underwent procalcitonin testing from 2020 onwards and were hospitalized in internal medicine or geriatric wards. Subsequently, the investigators will review medical records and extract relevant data regarding their disease course and outcomes.

Being tested
No Interventions
Keywords
Procalcitonin, CRP, Acute Infection, Internal Medicine Ward
Medical subject headings
Infections

What participants receive

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

  • No InterventionsOther

    No intervention, retrospective observational study

Study groups in NCT07770334
Study groupRoleWhat they receive
Positive ProcalcitoninAll patients hospitalized in internal medicine and geriatric wards with a diagnosis of acute infectious disease who underwent procalcitonin testing, starting in 2020.
Receives: Other: No Interventions

What is being measured

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

  1. Mortality

    Evaluation of procalcitonin as a prognostic marker in patients hospitalized in the internal medicine and geriatric department by examining mortality during hospitalization, within 7 days and within 30 months.

    Measured: 30 days

Secondary outcomes (2)

  1. Additional Outcomes - Length of stay

    Comparison of procalcitonin and CRP as predictors of length of hospital stay

    Measured: 30 days

  2. Additional data - morbidity

    need for vasopressors or mechanical ventilation, need for intensive care, need for invasive intervention

    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 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

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
Case only
Time perspective
Retrospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07770334
Sponsor's protocol ID
BRZ-0066-26
Status last verified
Aug 2026
First submitted
10 Aug 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared

Publications

  • Kibe S, Adams K, Barlow G. Diagnostic and prognostic biomarkers of sepsis in critical care. J Antimicrob Chemother. 2011 Apr;66 Suppl 2:ii33-40. doi: 10.1093/jac/dkq523.

    PubMed 21398306

  • 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.

    PubMed 21824946

  • Avrillon V, Locatelli-Sanchez M, Folliet L, Carbonnaux M, Perino E, Fossard G, Desseigne M, Freymond N, Geriniere L, Perrot E, Souquet PJ, Couraud S. Lung cancer may increase serum procalcitonin level. Infect Disord Drug Targets. 2015;15(1):57-63. doi: 10.2174/1871526515666150320162950.

    PubMed 25809625

  • Schupp T, Weidner K, Rusnak J, Jawhar S, Forner J, Dulatahu F, Dudda J, Bruck LM, Hoffmann U, Bertsch T, Akin I, Behnes M. C-reactive protein and procalcitonin during course of sepsis and septic shock. Ir J Med Sci. 2024 Feb;193(1):457-468. doi: 10.1007/s11845-023-03385-8. Epub 2023 May 19.

    PubMed 37204560

  • Rajkumari N, Mathur P, Sharma S, Gupta B, Bhoi S, Misra MC. Procalcitonin as a predictor of sepsis and outcome in severe trauma patients: a prospective study. J Lab Physicians. 2013 Jul;5(2):100-8. doi: 10.4103/0974-2727.119852.

    PubMed 24701102

  • Daud M, Khan MB, Qudrat QU, Ullah I, Khan S, Khan MZ, Yousuf I, Ahmad F. Role of C-reactive Protein and Procalcitonin in Early Diagnostic Accuracy and Their Prognostic Significance in Sepsis. Cureus. 2024 Sep 27;16(9):e70358. doi: 10.7759/cureus.70358. eCollection 2024 Sep.

    PubMed 39469363

  • Jain S, Sinha S, Sharma SK, Samantaray JC, Aggrawal P, Vikram NK, Biswas A, Sood S, Goel M, Das M, Vishnubhatla S, Khan N. Procalcitonin as a prognostic marker for sepsis: a prospective observational study. BMC Res Notes. 2014 Jul 17;7:458. doi: 10.1186/1756-0500-7-458.

    PubMed 25034373

  • Juneja D, Jain N, Singh O, Goel A, Arora S. Comparison between presepsin, procalcitonin, and CRP as biomarkers to diagnose sepsis in critically ill patients. J Anaesthesiol Clin Pharmacol. 2023 Jul-Sep;39(3):458-462. doi: 10.4103/joacp.joacp_560_21. Epub 2023 May 29.

    PubMed 38025554

  • Zincircioglu C, Rollas K, Guldogan IK, Saritas A, Ozkarakas H, Ersan G, Senoglu N. Diagnostic value of procalcitonin and C reactive protein for infection and sepsis in elderly patients. Turk J Med Sci. 2021 Oct;51(5):2649-2656. doi: 10.3906/sag-2007-268. Epub 2021 Oct 21.

    PubMed 34344141

  • Gregoriano C, Heilmann E, Molitor A, Schuetz P. Role of procalcitonin use in the management of sepsis. J Thorac Dis. 2020 Feb;12(Suppl 1):S5-S15. doi: 10.21037/jtd.2019.11.63.

    PubMed 32148921

Questions about this trial

What is this clinical trial studying?

An observational study of Procalcitonin and Infection, run by Barzilai Medical Center.

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 9 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: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Daniel Leshin Carmel Head of Infection Prevention and Control, MD (+972525253037, danielles@bmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 30 days). 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 NCT07770334, which also lists 10 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 18 Aug 2026.

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