A Clinical Trial of Procalcitonin-guided Antimicrobial Therapy in Sepsis

NCT03333304 | Completed

• 1 other identifier: PROGRESS
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 7

Brief Summary

The aim of the study is to demonstrate if using one procalcitonin (PCT)-guided rule of stop of antimicrobials, the incidence of infections by C.difficile and by Multi-Drug-Resistant (MDR) bacteria during the next six months may be significantly decreased.

Conditions

Sepsis

Keywords

Procalcitonin

Outcome Measures

Primary Outcomes (1)

• The change of infection-associated adverse events rate. The infection-associated adverse events rate are any case of Clostridium Difficile Infection (CDI) or infection by MDR or infection-related death.

  The change of infection-associated adverse events rate. The infection-associated adverse events rate are any case of Clostridium Difficile Infection (CDI) or infection by MDR or infection-related death.

  6 months

Secondary Outcomes (11)

• Infection-associated adverse events rate

  6 months

• Clostridium difficile Infection

  6 months

• Infections by MDR

  6 months

• Mortality

  28 days

• Mortality

  6 months

Study Arms (2)

PCT group

EXPERIMENTAL

Procalcitonin measurement and Discontinuation of antimicrobials according to Procalcitonin kinetics

Diagnostic Test: Procalcitonin measurement

Standard of care

NO INTERVENTION

Standard practice

Interventions

Procalcitonin measurement DIAGNOSTIC_TEST

Discontinuation of antimicrobials according to Procalcitonin Kinetics

PCT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• In case of women, unwillingness to remain pregnant during the study period.
• Age more than or equal to 18 years
• Sequential Organ Failure Assessment (SOFA) score more than or equal to 2 points for patients admitted in the emergencies and with a more than or equal to a 2-point increase of admission SOFA score for hospitalized patients.
• Presence of one of the following infections: community-acquired pneumonia, hospital-acquired pneumonia, ventilator-associated pneumonia, bacteremia and acute pyelonephritis. Any infection with onset more than 48 hours post hospital admission is considered one hospital-acquired infection.

You may not qualify if:

• Failure to obtain written consent to participate
• Patients receiving prolonged antibiotic therapies ( e.g. endocarditis, implantable device-associated infection, cerebral/hepatic abscess, osteomyelitis, meningitis)
• Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.)
• Patients infected with Mycobacterium tuberculosis.

Sponsors & Collaborators

• Hellenic Institute for the Study of Sepsis: lead

Study Sites (7)

1st Department of Internal Medicine, General Hospital of Athens "G. Gennimatas"

Athens, 11527, Greece

Location

3rd Department of Internal Medicine, Sotiria Athens General Hospital

Athens, 11527, Greece

Location

4th Department of Internal Medicine, Attikon University Hospital

Athens, 12462, Greece

Location

2nd Department of internal Medicine, General Hospital of Attiki "Sismanogleio"

Athens, 15126, Greece

Location

1st Department of Internal Medicine, General Hospital of Elefsina "Thriasio"

Athens, 19600, Greece

Location

2nd Department of Internal Medicine, General Hospital of Elefsina "Thriasio"

Athens, 19600, Greece

Location

2nd Department of Internal Medicine, General Hospital of Piraeus "Tzaneio"

Piraeus, 18536, Greece

Location

Related Publications (3)

• Kyriazopoulou E, Stylianakis E, Damoraki G, Koufargyris P, Kollias I, Katrini K, Drakou E, Marousis K, Spyrou A, Symbardi S, Alexiou N, Alexiou Z, Lada M, Poulakou G, Chrysos G, Adamis G, Giamarellos-Bourboulis EJ. Procalcitonin-guided early cessation of antibiotics prevents gut inflammation and preserves gut microbiome: Data from the PROGRESS controlled trial. Int J Antimicrob Agents. 2025 Aug;66(2):107507. doi: 10.1016/j.ijantimicag.2025.107507. Epub 2025 Apr 9.

  PMID: 40216091 DERIVED

• Kyriazopoulou E, Karageorgos A, Liaskou-Antoniou L, Koufargyris P, Safarika A, Damoraki G, Lekakis V, Saridaki M, Adamis G, Giamarellos-Bourboulis EJ. BioFire(R) FilmArray(R) Pneumonia Panel for Severe Lower Respiratory Tract Infections: Subgroup Analysis of a Randomized Clinical Trial. Infect Dis Ther. 2021 Sep;10(3):1437-1449. doi: 10.1007/s40121-021-00459-x. Epub 2021 Jun 13.

  PMID: 34120316 DERIVED

• Kyriazopoulou E, Liaskou-Antoniou L, Adamis G, Panagaki A, Melachroinopoulos N, Drakou E, Marousis K, Chrysos G, Spyrou A, Alexiou N, Symbardi S, Alexiou Z, Lagou S, Kolonia V, Gkavogianni T, Kyprianou M, Anagnostopoulos I, Poulakou G, Lada M, Makina A, Roulia E, Koupetori M, Apostolopoulos V, Petrou D, Nitsotolis T, Antoniadou A, Giamarellos-Bourboulis EJ. Procalcitonin to Reduce Long-Term Infection-associated Adverse Events in Sepsis. A Randomized Trial. Am J Respir Crit Care Med. 2021 Jan 15;203(2):202-210. doi: 10.1164/rccm.202004-1201OC.

  PMID: 32757963 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anastasia Antoniadou, MD, PhD

  National Kapodistrian University of Athens, Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized at 1:1 ratio by a separate list per study site into two treatment groups. The two groups of treatment will be as follows: * Standard of care: these patients will receive antimicrobials according to standard practice of the attending physicians but PCT will not be measured and antimicrobials will be stopped according to the local standard practice. * PCT group: these patients will receive antimicrobials according to standard practice of the attending physicians and antimicrobials will be discontinued according to PCT kinetics.

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 6, 2017
• Study Start: October 24, 2017
• Primary Completion: January 20, 2019
• Study Completion: July 20, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

GR (7)