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

Phase 1

• Conditions: SE 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; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-002011-33-GR
• Lead Sponsor: Hellenic Institute for the Study of Sepsis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-23
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 280

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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