Procalcitonin Monitoring May Decrease Antibiotic Use in the Intensive Care Unit

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Athens
ClinicalTrials.gov Identifier:
NCT01085994
First received: March 11, 2010
Last updated: October 6, 2010
Last verified: January 2010
  Purpose

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 Intervention
Sepsis
Other: Literature search

Study Type: Observational
Official Title: Procalcitonin-guided Algorithms of Antibiotic Stewardship in the Intensive Care Unit: Systematic Review and Meta-analysis

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Duration of antibiotic treatment for the first episode of infection [ Designated as safety issue: No ]
  • Total duration of antibiotic therapy [ Designated as safety issue: No ]
  • Antibiotic-free days at 28 days after study enrollment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 28-day mortality [ Designated as safety issue: No ]
  • In-hospital mortality [ Designated as safety issue: Yes ]
  • Length of ICU stay [ Designated as safety issue: Yes ]
  • Length of hospital stay [ Designated as safety issue: Yes ]
  • Days free of mechanical ventilation at 28 days after study enrollment [ Designated as safety issue: Yes ]
  • Rates of relapsed/persistent infection [ Designated as safety issue: Yes ]
  • Rate of superinfection [ Designated as safety issue: Yes ]
  • Financial cost of implementing a procalcitonin-based algorithm: purchase of the laboratory equipment/reagents, cost of the administered antibiotics, charges for hospital stay etc [ Designated as safety issue: No ]

Study Start Date: January 2010
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01085994

Locations
Greece
University of Athens - Medical School
Athens, Greece
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: Petros Kopterides, MD University of Athens Medical School
  More Information

Publications:
Responsible Party: Petros Kopterides, MD, University of Athens Medical School, 2nd Critical Care Department, "Attiko" University Hospital
ClinicalTrials.gov Identifier: NCT01085994     History of Changes
Other Study ID Numbers: PCT-2010
Study First Received: March 11, 2010
Last Updated: October 6, 2010
Health Authority: Greece: Ministry of Health

Keywords provided by University of Athens:
antibiotics
resistance
bio-marker
procalcitonin
algorithm
critically ill

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on October 19, 2014