Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 10:59 PM
Study NCT ID:
NCT00250666
Status:
COMPLETED
Last Update Posted:
2008-07-08
First Post:
2005-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procalcitonin-Guided Antimicrobial Discontinuation
Sponsor:
University Hospital, Geneva
Organization:
Study Overview
Official Title:
Procalcitonin-Guided Antimicrobial Discontinuation Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Sepsis
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current study aims to validate the diagnostic use of PCT assessing its capability to individualize and shorten the duration of antibiotic therapy in critically ill patients with suspected or confirmed sepsis.
In particular, no well-designed intervention study has properly examined the following hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic treatment duration in critically ill patients with suspected or documented sepsis, without harming patient safety.
In particular, no well-designed intervention study has properly examined the following hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic treatment duration in critically ill patients with suspected or documented sepsis, without harming patient safety.
Detailed Description:
Primary objective:
To assess the effect of repeated PCT measurements in critically ill patients with clinically suspected or microbiologically documented sepsis on duration of antimicrobial use and to compare this strategy to standard clinical practice, by using an improved PCT assay with a sensitivity of 0.06 ng/ml.
Secondary objectives:
To determine the impact of repeated PCT measurements on patient outcome (morbidity, mortality, emergence of antibiotic resistance and nosocomial super-infections).
Main measures:
Primary:
1. Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
Secondary:
2. Cure and failure rate of infection (in N recurrent infections per 100 patients)
3. 28-day case-fatality rate (in N deaths per 100 patients)
4. Length of hospital stay (in days)
5. Costs of antimicrobial therapy (in CHF)
6. Rate of nosocomial super-infection (in N super-infections per 100 patients)
7. Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-days)
To assess the effect of repeated PCT measurements in critically ill patients with clinically suspected or microbiologically documented sepsis on duration of antimicrobial use and to compare this strategy to standard clinical practice, by using an improved PCT assay with a sensitivity of 0.06 ng/ml.
Secondary objectives:
To determine the impact of repeated PCT measurements on patient outcome (morbidity, mortality, emergence of antibiotic resistance and nosocomial super-infections).
Main measures:
Primary:
1. Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
Secondary:
2. Cure and failure rate of infection (in N recurrent infections per 100 patients)
3. 28-day case-fatality rate (in N deaths per 100 patients)
4. Length of hospital stay (in days)
5. Costs of antimicrobial therapy (in CHF)
6. Rate of nosocomial super-infection (in N super-infections per 100 patients)
7. Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-days)
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: