Procalcitonin-Guided Antimicrobial Discontinuation

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

PCT measurement

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring Biological Markers, Procalcitonin, Critical Care, Diagnosis, Differential, Prospective Study, Sepsis, Antibiotic stewardship, Antimicrobial resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with clinically suspected or microbiologically confirmed bacterial sepsis Informed consent Exclusion Criteria: 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

Sites / Locations

Geneva Universits Hospitals

Outcomes

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)

Full Information

NCT ID

NCT00250666

First Posted

November 7, 2005

Last Updated

July 7, 2008

Sponsor

University Hospital, Geneva

1. Study Identification

Unique Protocol Identification Number

NCT00250666

Brief Title

Procalcitonin-Guided Antimicrobial Discontinuation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

May 2007 (undefined)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Geneva

4. Oversight

5. Study Description

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.

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: 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) 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

Keywords

Biological Markers, Procalcitonin, Critical Care, Diagnosis, Differential, Prospective Study, Sepsis, Antibiotic stewardship, Antimicrobial resistance

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Single

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

PCT measurement

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Cure and failure rate of infection (in N recurrent infections per 100 patients)

Title

28-day case-fatality rate (in N deaths per 100 patients)

Title

Length of hospital stay (in days)

Title

Costs of antimicrobial therapy (in CHF)

Title

Rate of nosocomial super-infection (in N super-infections per 100 patients)

Title

Isolation of multi-resistant microorganisms (in clinical isolates per 100 patient-days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients with clinically suspected or microbiologically confirmed bacterial sepsis Informed consent Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephan J Harbarth, MD MS

Organizational Affiliation

University Hospital, Geneva

Official's Role

Principal Investigator

Facility Information:

Facility Name

Geneva Universits Hospitals

City

Geneva

ZIP/Postal Code

1211

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

18096708

Citation

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.

Results Reference

derived

Sepsis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial