Text Size

Procalcitonin as a Tool to Shorten Antibiotic Therapy in the ICU

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rodrigo Octavio Deliberato, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT01494675
First received: December 13, 2011
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Antibiotics Sepsis
U.S. FDA Resources

Further study details as provided by Hospital Israelita Albert Einstein:

Primary Outcome Measures:
  • reducing the duration of antibiotic therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 13, 2011
Last Updated: December 15, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by 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
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013