Procalcitonin as a Tool to Shorten Antibiotic Therapy in the ICU

Clinical Impact of Procalcitonin to Shorten Antimicrobial Therapy in Septic Patients With Proven Bacterial Infection in an Intensive Care Setting

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: procalcitonin measurement

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sâo Paulo
    • São Paulo, Sâo Paulo, Brazil, 05641-901
      • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Interventional Model: Parallel Assignment
• Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reducing the duration of antibiotic therapy	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all cause mortality	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	2 years

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: Rodrigo O Deliberato, M.D., Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 19, 2011

Study Record Updates

• Last Update Posted (Estimate): December 19, 2011
• Last Update Submitted That Met QC Criteria: December 15, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: sepsis; procalcitonin; duration of the antibiotic therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: PCT