We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00870623
Recruitment Status : Unknown
Verified March 2011 by University of Nebraska.
Recruitment status was:  Recruiting
First Posted : March 27, 2009
Last Update Posted : March 2, 2011
Information provided by:
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
Infection of Bloodstream

Study Type : Observational
Estimated Enrollment : 136 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
Estimated Primary Completion Date : June 2011

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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

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


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
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: March 2011

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