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Procalcitonin Monitoring May Decrease Antibiotic Use in the Intensive Care Unit

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. 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
Information provided by:
University of Athens

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.

Condition or disease Intervention/treatment
Sepsis Other: Literature search

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.

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Study Type : Observational
Official Title: Procalcitonin-guided Algorithms of Antibiotic Stewardship in the Intensive Care Unit: Systematic Review and Meta-analysis
Study Start Date : January 2010
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Group/Cohort Intervention/treatment
Procalcitonin-guided group Other: Literature search
Literature search followed by systematic review and meta-analysis

Routine practice group Other: Literature search
Literature search followed by systematic review and meta-analysis

Primary Outcome Measures :
  1. Duration of antibiotic treatment for the first episode of infection
  2. Total duration of antibiotic therapy
  3. Antibiotic-free days at 28 days after study enrollment

Secondary Outcome Measures :
  1. 28-day mortality
  2. In-hospital mortality
  3. Length of ICU stay
  4. Length of hospital stay
  5. Days free of mechanical ventilation at 28 days after study enrollment
  6. Rates of relapsed/persistent infection
  7. Rate of superinfection
  8. Financial cost of implementing a procalcitonin-based algorithm: purchase of the laboratory equipment/reagents, cost of the administered antibiotics, charges for hospital stay etc

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

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 identifier (NCT number): NCT01085994

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University of Athens - Medical School
Athens, Greece
Sponsors and Collaborators
University of Athens
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Principal Investigator: Petros Kopterides, MD University of Athens Medical School
Publications of Results:
Other Publications:
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Responsible Party: Petros Kopterides, MD, University of Athens Medical School, 2nd Critical Care Department, "Attiko" University Hospital Identifier: NCT01085994    
Other Study ID Numbers: PCT-2010
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: October 7, 2010
Last Verified: January 2010
Keywords provided by University of Athens:
critically ill