Procalcitonin and Endotoxin Sequential Levels to Optimize the Treatment of Bloodstream Infections

Study Overview
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Brief Summary
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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
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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.

Official Title
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Procalcitonin and Endotoxin Sequential Levels to Optimize the Treatment of Bloodstream Infections

Conditions
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Bloodstream Infection

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal length of treatment | To determine the optimal length of treatment by observing the normalization of procalcitonin (PCT) and Endotoxin levels, compared with the length of treatment by standard of care. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of procalcitonin and endotoxin levels and outcomes | To determine if procalcitonin and endotoxin levels (or lack of decrease) are associated with treatment failure, complication, survival, cost, length of stay, progression to severe sepsis, or superinfections. | 30 days |