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Procalcitonin-Guided Antimicrobial Discontinuation

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00250666
First received: November 7, 2005
Last updated: July 7, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Sepsis
 Procedure: PCT measurement
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Procalcitonin-Guided Antimicrobial Discontinuation Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sepsis
U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)

Secondary Outcome Measures:
  • Cure and failure rate of infection (in N recurrent infections per 100 patients)
  • 28-day case-fatality rate (in N deaths per 100 patients)
  • Length of hospital stay (in days)
  • Costs of antimicrobial therapy (in CHF)
  • Rate of nosocomial super-infection (in N super-infections per 100 patients)
  • Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-days)

Estimated Enrollment: 70
Study Start Date: January 2006
Study Completion Date: May 2007
Estimated Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: PCT measurement
    Peripheral blood samples were collected in the morning, using vacuum tubes (BD Vacutainer SST II Plus plastic tubes; Becton Dickinson Diagnostic Systems, Allschwil, Switzerland). Circulating plasma PCT levels were measured with a time-resolved amplified cryptate emission technology assay (Kryptor PCT; Brahms AG, Hennigsdorf, Germany), with an assay sensitivity of 0.06 mg/L, approximately fourfold above mean normal levels. Measurements were performed 7 days a week.
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with clinically suspected or microbiologically confirmed bacterial sepsis
  2. Informed consent

Exclusion Criteria:

  1. Patients with microbiologically documented infections caused by the following microorganisms: Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis, Staphylococcus aureus
  2. Patients with fungal infections
  3. Patients with severe infections due to viruses or parasites (e.g. hemorrhagic fever, malaria)
  4. Patients with suspected or confirmed bacterial meningitis or endocarditis
  5. Patients with localized, deep-seated abscesses (e.g. brain abscess) without systemic sepsis
  6. Patients with chronic, localized infections (e.g. chronic osteomyelitis) without systemic sepsis
  7. Neutropenic and other severely immuno-compromised patients (patients infected with human immunodeficiency virus and a CD4 count < 200; patients on immuno-suppressive therapy after solid organ transplantation; patients with cystic fibrosis)
  8. Withholding of life-support
  9. Early discharge or death (< 24 hours after admission)
  10. Complete absence of antimicrobial treatment despite suspicion of sepsis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250666

Locations
Switzerland
Geneva Universits Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Stephan J Harbarth, MD MS University Hospital, Geneva
  More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00250666     History of Changes
Other Study ID Numbers: HUG 05-146
Study First Received: November 7, 2005
Last Updated: July 7, 2008
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Biological Markers
Procalcitonin
Critical Care
Diagnosis, Differential
 Prospective Study
Sepsis
Antibiotic stewardship
Antimicrobial resistance

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013