NCT00250666

Procalcitonin-Guided Antimicrobial Discontinuation

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: 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)

Conditions

• Sepsis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2005-11-08
• Last updated: 2008-07-08

Locations

1 site across 1 country: Switzerland