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Procalcitonin as a Tool to Shorten Antibiotic Therapy in the ICU

NCT ID: NCT01494675

Last Updated: 2011-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-02-28

Brief Summary

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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

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Conditions

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Sepsis

Keywords

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procalcitonin duration of the antibiotic therapy sepsis

Study Design

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Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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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"

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Octavio Deliberato

ICU staff physician at Hospital Israelita Albert Einstein

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodrigo O Deliberato, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

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Hospital Israelita Albert Einstein

São Paulo, Sâo Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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PCT

Identifier Type: -

Identifier Source: org_study_id