NCT00250666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 sepsis

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 8, 2008

Status Verified

July 1, 2008

Enrollment Period

1.3 years

First QC Date

November 7, 2005

Last Update Submit

July 7, 2008

Conditions

Sepsis

Keywords

Biological MarkersProcalcitoninCritical CareDiagnosis, DifferentialProspective StudySepsisAntibiotic stewardshipAntimicrobial resistance

Outcome Measures

Primary Outcomes (1)

  • Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)

Secondary Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Interventions

PCT measurementPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinically suspected or microbiologically confirmed bacterial sepsis
  • Informed consent

You may not qualify if:

  • Patients with microbiologically documented infections caused by the following microorganisms: Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis, Staphylococcus aureus
  • Patients with fungal infections
  • Patients with severe infections due to viruses or parasites (e.g. hemorrhagic fever, malaria)
  • Patients with suspected or confirmed bacterial meningitis or endocarditis
  • Patients with localized, deep-seated abscesses (e.g. brain abscess) without systemic sepsis
  • Patients with chronic, localized infections (e.g. chronic osteomyelitis) without systemic sepsis
  • 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)
  • Withholding of life-support
  • Early discharge or death (\< 24 hours after admission)
  • Complete absence of antimicrobial treatment despite suspicion of sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva Universits Hospitals

Geneva, 1211, Switzerland

Location

Related Publications (1)

  • Nobre V, Harbarth S, Graf JD, Rohner P, Pugin J. Use of procalcitonin to shorten antibiotic treatment duration in septic patients: a randomized trial. Am J Respir Crit Care Med. 2008 Mar 1;177(5):498-505. doi: 10.1164/rccm.200708-1238OC. Epub 2007 Dec 20.

    PMID: 18096708DERIVED

MeSH Terms

Conditions

SepsisDisease

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephan J Harbarth, MD MS

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 8, 2005

Study Start

January 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

July 8, 2008

Record last verified: 2008-07

Locations

CH(1)