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

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ClinicalTrials.gov Identifier: NCT00870623
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Andre Kalil, MD, University of Nebraska

Brief Summary:
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. We hypothesize that a procalcitonin (host biomarker) and endotoxin (microorganism biomarker)-guided treatment plan could significantly decrease unnecessary exposure to antibiotics in patients with bloodstream infections.

Condition or disease
Bloodstream Infection

Study Type : Observational
Actual Enrollment : 223 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procalcitonin and Endotoxin Sequential Levels to Optimize the Treatment of Bloodstream Infections
Study Start Date : June 2009
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016



Primary Outcome Measures :
  1. 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. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 30 days ]

Biospecimen Retention:   Samples Without DNA
Blood (maximum 40mL) will be collected for future use or for purposes that are not integral to the current research.


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospitalized adult patients with positive blood cultures
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870623


Locations
United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska

Publications:

Responsible Party: Andre Kalil, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00870623     History of Changes
Other Study ID Numbers: 540-08-FB
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Infection
Communicable Diseases
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs