Skip to main content
OpenTrials
Completed

NCT Number: NCT01494675

Procalcitonin as a Tool to Shorten Antibiotic Therapy in the ICU

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Israelita Albert Einstein

São Paulo, Sâo Paulo, 05641-901, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

procalcitonin measurement

Other

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"

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2011
Registry last updated
Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.