Clinical trial NCT00870623: Procalcitonin and Endotoxin Sequential Levels to Optimize the Treatment of Bloodstream Infections
Official title: Procalcitonin and Endotoxin Sequential Levels to Optimize the Treatment of Bloodstream Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bloodstream Infection
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 223
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized adult patients with positive blood cultures

Brief summary: Bloodstream infections (BSI) are a major cause of morbidity and mortality. Bloodstream infections are also costly and result in prolonged hospital stays. The duration of therapy necessary to clear blood stream infections is unknown and no study has systematically addressed this issue. However, the use of antimicrobials is not without consequence. These include financial cost, side-effects, promotion of superinfection (especially Clostridium difficile-associated diarrhea), and the promotion of microbial resistance. This study hypothesizes that a procalcitonin (host biomarker) and endotoxin (microorganism biomarker) guided treatment plan could significantly decrease unnecessary exposure to antibiotics in patients with bloodstream infections.

Detailed description: Bloodstream infections (BSI) are a major cause of morbidity and mortality. Community-onset BSI have an overall attributable mortality of 10-13% while nosocomial BSI mortality ranges are quite variable from 12-80%. Bloodstream infections are also costly and result in prolonged hospital stays. Nosocomial BSIs have been shown to increase length of stay by 5-25 days and increase costs $23,000 - 40,000 above matched controls. The duration of therapy necessary to clear blood stream infections is unknown and no study has systematically addressed this issue. The use of antimicrobials is also not without consequence. These include financial cost, side-effects, promotion of superinfection (especially Clostridium difficile-associated diarrhea), and the promotion of microbial resistance. This study hypothesizes that a procalcitonin (host biomarker) and endotoxin (microorganism biomarker) guided treatment plan could significantly decrease unnecessary exposure to antibiotics in patients with bloodstream infections.

Eligibility criteria: Inclusion Criteria:

* Hospitalized, adult patient, at least one positive blood culture reported within 24 hours of enrollment

Exclusion Criteria:

* Previously enrolled in the study; discharged/deceased before first positive culture; receiving antibiotic for greater than or equal to 48 hours; endocarditis or osteomyelitis; antithymocyte globulin in the last 12 months; blood cultures positive for coagulase-negative staphylococcus only.

Primary outcomes:
measure: Optimal length of treatment
timeFrame: 30 days
Secondary outcomes:
measure: Association of procalcitonin and endotoxin levels and outcomes
timeFrame: 30 days
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Andre Kalil, MD
role: PRINCIPAL_INVESTIGATOR
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