Procalcitonin as a Tool to Shorten Antibiotic Therapy in the ICU

Not Applicable

Completed

• Conditions: Sepsis

• Registration Number: NCT01494675
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2011-12
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-15
• Last Update Submitted: 2011-12-15
• Study First Posted: 2011-12-19
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
reducing the duration of antibiotic therapy	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

Name	Time	Method
all cause mortality	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

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Sâo Paulo, Brazil