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Procalcitonin Monitoring May Decrease Antibiotic Use in the Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT01085994
Recruitment Status : Unknown
Verified January 2010 by University of Athens.
Recruitment status was:  Enrolling by invitation
First Posted : March 12, 2010
Last Update Posted : October 7, 2010
Sponsor:
Information provided by:
University of Athens

Tracking Information
First Submitted Date March 11, 2010
First Posted Date March 12, 2010
Last Update Posted Date October 7, 2010
Study Start Date January 2010
Estimated Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2010)
  • Duration of antibiotic treatment for the first episode of infection
  • Total duration of antibiotic therapy
  • Antibiotic-free days at 28 days after study enrollment
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01085994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 16, 2010)
  • 28-day mortality
  • In-hospital mortality
  • Length of ICU stay
  • Length of hospital stay
  • Days free of mechanical ventilation at 28 days after study enrollment
  • Rates of relapsed/persistent infection
  • Rate of superinfection
  • Financial cost of implementing a procalcitonin-based algorithm: purchase of the laboratory equipment/reagents, cost of the administered antibiotics, charges for hospital stay etc
Original Secondary Outcome Measures
 (submitted: March 11, 2010)
  • 28-day mortality
  • In-hospital mortality
  • Length of ICU stay
  • Length of hospital stay
  • Days free of mechanical ventilation at 28 days after study enrollment
  • Rates of relapsed/persistent infection
  • Rate of superinfection
  • Cost
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Procalcitonin Monitoring May Decrease Antibiotic Use in the Intensive Care Unit
Official Title Procalcitonin-guided Algorithms of Antibiotic Stewardship in the Intensive Care Unit: Systematic Review and Meta-analysis
Brief Summary Sepsis is common and is associated with significant mortality, morbidity and health-care costs. Unfortunately, its diagnosis is not straightforward because its signs and symptoms are neither specific nor sensitive; in addition, microbiological cultures lack specificity, sensitivity and are plagued by high turn-around times. Because the delay in the institution of antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in ICU-patients, even when they are not needed. Procalcitonin may not be the long sought for bio-marker to establish the diagnosis of sepsis but may help decrease the duration of the administered antibiotic courses once they are started.
Detailed Description Recently, a number of studies have shown the utility of procalcitonin (PCT) measurements in reducing the duration of antibiotic treatment in patients with respiratory tract infections presenting to the primary care setting or the emergency department. However, it remains unclear if a similar strategy can be effectively and safely implemented in the critical care setting. We attempt to address the controversy on this issue, by collecting, analyzing and interpreting the currently available relevant evidence. To this end, a systematic review and meta-analysis of the randomized controlled trials reporting on the outcomes of critically ill septic patients managed with or without a procalcitonin-based algorithm will be performed.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population We will systematically search PubMed, Scopus and the Cochrane Central Register of Controlled Trials to identify relevant randomized controlled trials by using the following search terms: procalcitonin AND ("critically ill" OR "intensive care" OR "critical care"). The reference lists of the initially retrieved articles will also be reviewed. Abstracts of conference proceedings will not be sought because they commonly present data that differ from the full publications. Finally, the corresponding authors of each one of the included studies will be contacted by e-mail for additional information and clarifications if needed.
Condition Sepsis
Intervention Other: Literature search
Literature search followed by systematic review and meta-analysis
Study Groups/Cohorts
  • Procalcitonin-guided group
    Intervention: Other: Literature search
  • Routine practice group
    Intervention: Other: Literature search
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment Not Provided
Original Enrollment Not Provided
Estimated Study Completion Date March 2010
Estimated Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Randomized controlled trials (RCTs) that report on the outcomes of critically ill patients managed with a procalcitonin-guided algorithm versus routine practice.
  • Participants of any age with proven or suspected sepsis will be considered. - As routine practice, the investigators will consider the institution and discontinuation of antibiotics by the attending physicians with the aid of clinical signs, symptoms, microbiological data, well established laboratory parameters (i.e., white blood cell count) and widely accepted guidelines but without the knowledge of PCT values. The investigators will set no limitations regarding the time, country or language of publications. The investigators will search for trials conducted in critically ill neonates and children.

Exclusion Criteria:

  • The investigators will exclude studies that are not RCTs and studies performed outside the ICU, namely in the primary care setting, the emergency department or the clinic.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT01085994
Other Study ID Numbers PCT-2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Petros Kopterides, MD, University of Athens Medical School, 2nd Critical Care Department, "Attiko" University Hospital
Study Sponsor University of Athens
Collaborators Not Provided
Investigators
Principal Investigator: Petros Kopterides, MD University of Athens Medical School
PRS Account University of Athens
Verification Date January 2010