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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00870623
First received: March 26, 2009
Last updated: March 1, 2011
Last verified: March 2011
  Purpose

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
Infection of Bloodstream

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procalcitonin and Endotoxin Sequential Levels to Optimize the Treatment of Bloodstream Infections

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 136
Study Start Date: June 2009
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00870623

Contacts
Contact: Penny Hardiman, RN 402 559-8930 phardiman@unmc.edu
Contact: Andre Kalil, MD 402 559-8650 akalil@unmc.edu

Locations
United States, Nebraska
The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Andre Kalil, MD    402-559-8650    akalil@unmc.edu   
Contact: Penny Hardiman, RN    402 559-8930    phardiman@unmc.edu   
Sub-Investigator: Trevor Vanschooneveld, MD         
Principal Investigator: Andre kalil, MD         
Sponsors and Collaborators
University of Nebraska
  More Information

Publications:
13. Rice LB. The Maxwell Finland Lecture: for the duration-rational antibiotic administration in an era of antimicrobial resistance and clostridium difficile. Clin Infect Dis. 2006;43:S100-5.
16. Stolz D, Christ-Crain M, Bingisser R, et al. Antibiotic treatment of exacerbations of COPD. Chest. 2007;131:9.

Responsible Party: Andre Kalil, MD, Principal Investigator, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00870623     History of Changes
Other Study ID Numbers: 540-08-FB
Study First Received: March 26, 2009
Last Updated: March 1, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on October 20, 2014