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OpenTrials
Completed

NCT Number: NCT00870623

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Optimal length of treatment

    Time frame: 30 days

    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.

Secondary outcomes

  1. Association of procalcitonin and endotoxin levels and outcomes

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Mar 27, 2009
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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