Procalcitonin-Guided Antimicrobial Discontinuation

Sepsis Clinical Trial

Official title:

Procalcitonin-Guided Antimicrobial Discontinuation Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250666
• Other study ID #: HUG 05-146
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2005
• Last updated: July 7, 2008
• Start date: January 2006
• Est. completion date: May 2007

Study information

• Verified date: July 2008
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sepsis

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Geneva Universits Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
Secondary	Cure and failure rate of infection (in N recurrent infections per 100 patients)
Secondary	28-day case-fatality rate (in N deaths per 100 patients)
Secondary	Length of hospital stay (in days)
Secondary	Costs of antimicrobial therapy (in CHF)
Secondary	Rate of nosocomial super-infection (in N super-infections per 100 patients)
Secondary	Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-days)