A Phase 4 interventional study of PCT measurement in Sepsis, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-07-08.
Sponsored by University Hospital, Geneva · Phase 4, Interventional, and Diagnostic
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.
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:
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 70 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
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)
This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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University Hospital, Geneva