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Procalcitonin as a Tool to Shorten Antibiotic Therapy in the ICU

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01494675
First Posted: December 19, 2011
Last Update Posted: December 19, 2011
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.
Information provided by (Responsible Party):
Rodrigo Octavio Deliberato, Hospital Israelita Albert Einstein
  Purpose
Recently, biomarkers like procalcitonin have been studied in order to help physicians to decrease the duration of the antibiotic therapy. The investigators objective was to assess whether the decrease in procalcitonin levels could be used to reduce the antibiotic therapy in critically ill patients with a proven infection without risking a worse outcome.

Condition Intervention
Sepsis Other: procalcitonin measurement

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Clinical Impact of Procalcitonin to Shorten Antimicrobial Therapy in Septic Patients With Proven Bacterial Infection in an Intensive Care Setting

Resource links provided by NLM:


Further study details as provided by Rodrigo Octavio Deliberato, Hospital Israelita Albert Einstein:

Primary Outcome Measures:
  • reducing the duration of antibiotic therapy [ Time Frame: 2 years ]
    the primary objective was to assess if a procalcitonin measurement protocol can reduce the duration of antibiotic therapy in critically ill patients with sepsis, severe sepsis and septic shock with documented infection


Secondary Outcome Measures:
  • all cause mortality [ Time Frame: 2 years ]
    The secondary endpoints were in-hospital mortality, ICU mortality, ICU length of stay, recurrence of the initial infection, analyis of the C-reative protein levels along with the procalcitonin protocol and costs


Enrollment: 81
Study Start Date: March 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: procalcitonin measurement

    The patients assigned to the procalcitonin group had procalcitonin and C reactive protein levels measured at day 0 (bacteremia), 5 or 7 (if positive blood culture) and then every 48 hours until hosptital discharge, death or until the antibiotics were stopped. A predefined procalcitonin protocol was used together with the clinical outcome, to guide the physician´s decision to discontinue antibiotics.

    The procalcitonin protocol encouraged the physician to discontinue the antibiotics when: 1)procalcitonin dropped more than 90% from the baseline peak level or 2)an absolute value below 0,5ng/mL was reached. Cases in which the antibiotic treatment was continued against what the PCT values indicated were categorized as " antibiotic discontinuation overruling"

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients admitted in the intensive care unit with sepsis, severe sepsis and septic shock with a microbiologically confirmed infection (blood, urine, tracheal aspirate or bronchoalveolar fluid culture)

Exclusion Criteria:

  • onset of the antibiotic therapy more than 48 hours before the date when the cultures were performed
  • patients less than 18 years old
  • known pregnancy
  • infections requiring prolonged antibotic therapy such as endocarditis, hepatic or brain abscess, deep abscess, mediastinitis and osteomyelitis
  • severe infection caused by virus, parasites, fungi or chronic prostatitis
  • negative cultures in patients with suspected sepsis, severe sepsis or septic shock
  Contacts and Locations
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): NCT01494675


Locations
Brazil
Hospital Israelita Albert Einstein
São Paulo, Sâo Paulo, Brazil, 05641-901
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
Principal Investigator: Rodrigo O Deliberato, M.D. Hospital Israelita Albert Einstein
  More Information

Responsible Party: Rodrigo Octavio Deliberato, ICU staff physician at Hospital Israelita Albert Einstein, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT01494675     History of Changes
Other Study ID Numbers: PCT
First Submitted: December 13, 2011
First Posted: December 19, 2011
Last Update Posted: December 19, 2011
Last Verified: December 2011

Keywords provided by Rodrigo Octavio Deliberato, Hospital Israelita Albert Einstein:
procalcitonin
duration of the antibiotic therapy
sepsis

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Calcitonin
Anti-Infective Agents
Antitubercular Agents
Bone Density Conservation Agents
Physiological Effects of Drugs


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