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NCT00870623 Clinical Trial

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

Bloodstream Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00870623
Other study ID # 0540-08-FB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2009
Est. completion date January 13, 2016

Study information
Verified date September 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

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Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Unversity of Nebraska Medical Center Omaha Nebraska

Sponsors (1)
Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (26)

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Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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