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

Completed

• Conditions: Bloodstream Infection

• Registration Number: NCT00870623
• Lead Sponsor: University of Nebraska

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Study Start: 2009-06-01
• Primary Completion: 2016-01-13
• Study Completion: 2016-01-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Optimal length of treatment	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 Outcome Measures

Name	Time	Method
Association of procalcitonin and endotoxin levels and outcomes	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.

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States