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NCT Number: NCT00250666

Procalcitonin-Guided Antimicrobial Discontinuation

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.

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Key information

Conditions

Sepsis Disease Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Geneva Universits Hospitals

Geneva, 1211, Switzerland

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCT measurement

Procedure

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 outcomes

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

Secondary outcomes

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

  2. 28-day case-fatality rate (in N deaths per 100 patients)

  3. Length of hospital stay (in days)

  4. Costs of antimicrobial therapy (in CHF)

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

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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 8, 2005
Registry last updated
Jul 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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