Procalcitonin as a Tool to Shorten Antibiotic Therapy in the ICU

NCT01494675 | Completed DMC

• 1 other identifier: PCT
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

procalcitonin; duration of the antibiotic therapy; sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• all cause mortality

  2 years

Interventions

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"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, Sâo Paulo, 05641-901, Brazil

Location

MeSH Terms

Conditions

Sepsis

Interventions

Procalcitonin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Calcitonin; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Protein Precursors; Proteins

Study Officials

• Rodrigo O Deliberato, M.D.

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU staff physician at Hospital Israelita Albert Einstein

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 19, 2011
• Study Start: March 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 19, 2011

Record last verified: 2011-12

Locations

BR (1)