A CLINICAL TRIAL FOR THE USE OF PROCALCITONIN IN EARLY STOP OF ANTIBIOTICS TO AVOID LONG-TERM CONSEQUENCES

A RANDOMIZED PROSPECTIVE CLINICAL TRIAL TO ASSESS THE ROLE OF PROCALCITONIN-GUIDED ANTIMICROBIAL THERAPY TO REDUCE LONG-TERM INFECTIONS SEQUELAE - PROGRESS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002011-33-GR

Enrollment

280

Registered

2017-06-23

Start date

2017-08-28

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

USE OF PROCALCITONIN IN EARLY STOP OF ANTIBIOTICS TO AVOID LONG-TERM CONSEQUENCES MedDRA version: 20.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Standard of care. Patients will receive standard of care antibiotics. No specific antibiotic will be prescribed. Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female • In case of women, unwillingness to remain pregnant during the study period. • Age more than or equal to 18 years • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: • Failure to obtain written consent to participate • Patients in pregnancy or breastfeeding. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study • 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to demonstrate if using one PCT-guided rule of stop of antimicrobials, the incidence of infections by C.difficile and by MDR bacteria during the next six months may be significantly decreased.;Secondary Objective: Not applicable;Primary end point(s): The primary study endpoint will be the change of infection-associated adverse events rate for patients treated by the PCT-guided stopping rule compared to patients treated by standard of care. The infection-associated adverse events rate is considered as the advent of any case of CDI or infection by MDR or infection-related death with the first six months from study inclusion. ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: The aim of the study is to demonstrate if using one PCT-guided rule of stop of antimicrobials, the incidence of infections by C.difficile and by MDR bacteria during the next six months may be significantly decreased.;Secondary Objective: Not applicable;Primary end point(s): The primary study endpoint will be the change of infection-associated adverse events rate for patients treated by the PCT-guided stopping rule compared to patients treated by standard of care. The infection-associated adverse events rate is considered as the advent of any case of CDI or infection by MDR or infection-related death with the first six months from study inclusion. ;Timepoint(s) of evaluation of this end point: 6 months

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Secondary

Measure	Time frame
Secondary end point(s): • Time to first infection-associated adverse events rate until month 6. For patients with more than one infection-associated adverse event the first one is encountered. • Rate of CDI until month 6. For patients with more than one episode of CDI the first one is encountered. • Rate of infections by MDR until month 6. For patients with more than one infection by MDR event the first one is encountered. • 28-day mortality • 6-month mortality • Rate stool positive for GDH by C.difficile until month 6 • Rate of stool colonization by MDR until month 6 • Microbiome composition on day 28 • Changes of the microbiome between days 1 and 28. • Consumption of antimicrobials until hospital discharge • Real cost until hospital discharge. ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Secondary end point(s): • Time to first infection-associated adverse events rate until month 6. For patients with more than one infection-associated adverse event the first one is encountered. • Rate of CDI until month 6. For patients with more than one episode of CDI the first one is encountered. • Rate of infections by MDR until month 6. For patients with more than one infection by MDR event the first one is encountered. • 28-day mortality • 6-month mortality • Rate stool positive for GDH by C.difficile until month 6 • Rate of stool colonization by MDR until month 6 • Microbiome composition on day 28 • Changes of the microbiome between days 1 and 28. • Consumption of antimicrobials until hospital discharge • Real cost until hospital discharge. ;Timepoint(s) of evaluation of this end point: 6 months

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Countries

Greece

Contacts

Public ContactPresident of the Board

Hellenic Institute for the Study of Sepsis

insepsis@otenet.gr00302107480662

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026