Procalcitonin as a Tool to Shorten Antibiotic Therapy in the ICU
This study has been completed.
Information provided by (Responsible Party):
Rodrigo Octavio Deliberato, Hospital Israelita Albert Einstein
First received: December 13, 2011
Last updated: December 15, 2011
Last verified: December 2011
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.
Other: procalcitonin measurement
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
||Clinical Impact of Procalcitonin to Shorten Antimicrobial Therapy in Septic Patients With Proven Bacterial Infection in an Intensive Care Setting
Primary Outcome Measures:
Secondary Outcome Measures:
- all cause mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2010 (Final data collection date for primary outcome measure)
Other: 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"
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494675
|Hospital Israelita Albert Einstein
|São Paulo, Sâo Paulo, Brazil, 05641-901 |
Hospital Israelita Albert Einstein
||Rodrigo O Deliberato, M.D.
||Hospital Israelita Albert Einstein
||Rodrigo Octavio Deliberato, ICU staff physician at Hospital Israelita Albert Einstein, Hospital Israelita Albert Einstein
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 13, 2011
||December 15, 2011
||Brazil: National Health Surveillance Agency
Keywords provided by Hospital Israelita Albert Einstein:
duration of the antibiotic therapy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 29, 2016
Systemic Inflammatory Response Syndrome
Bone Density Conservation Agents
Physiological Effects of Drugs