Procalcitonin as a Tool to Shorten Antibiotic Therapy in the ICU
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ClinicalTrials.gov Identifier: NCT01494675
Recruitment Status :
First Posted : December 19, 2011
Last Update Posted : December 19, 2011
Hospital Israelita Albert Einstein
Information provided by (Responsible Party):
Rodrigo Octavio Deliberato, Hospital Israelita Albert Einstein
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.
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"
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 Outcome Measures :
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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
onset of the antibiotic therapy more than 48 hours before the date when the cultures were performed
patients less than 18 years old
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