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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00934011 |
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Date of registration:
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07/07/2009 |
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Primary sponsor: |
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Public title:
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Use of Inflammatory Biomarkers to Guide Antibiotic Therapy in Patients With Severe Infections
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Scientific title:
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Comparative Study of C-reactive Protein vs. Procalcitonin to Guide Antibiotic Therapy in Patients With Severe Sepsis and Septic Shock Admitted to the Intensive Care Unit. |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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94 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00934011 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Carolina F Oliveira, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical School of the Federal University of Minas Gerais |
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Name:
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Fernando A Botoni, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical School of the Federal University of Minas Gerais |
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Name:
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Vandack A Nobre, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical School of the Federal University of Minas Gerais |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age > 17 years
- patients in intensive care unit
- signed informed consent
- suspected or confirmed severe sepsis or septic shock
Exclusion Criteria:
- Infections caused by Listeria spp, Legionella pneumophilia, Mycobacterium
tuberculosis
- Bacteremia due S. aureus
- Infections requiring prolonged therapies, such as endocarditis, cerebral abscess,
chronic osteomyelitis
- Suspected or confirmed infection caused by virus, parasites
- Infections caused by P. aeruginosa ou A. baumannii
- Severe immunosuppression (ex: AIDS, post bone-marrow transplant,cystic fibrosis)
- Traumatism latest five days
- Surgery latest 5 days
- Carcinoid tumor, lung cancer, medullary thyroid cancer
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Septic Shock
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Severe Sepsis
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Intervention(s)
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Other: C-reactive protein guided antibiotic therapy
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Other: Procalcitonin guided antibiotic therapy
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Primary Outcome(s)
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Days alive without antibiotics
[Time Frame: 28 days]
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Duration of antibiotic therapy for the first episode of infection
[Time Frame: 28 days]
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Total antibiotic exposure days per 1,000 days
[Time Frame: 28 days]
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Secondary Outcome(s)
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All cause 28-day mortality
[Time Frame: 28 days]
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clinical cure rate
[Time Frame: 28 days]
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In-hospital mortality
[Time Frame: 28 days]
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Infection relapse (diagnosed less than 48h after antibiotic discontinuation)
[Time Frame: 48 hours]
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Isolation of resistant bacteria
[Time Frame: 28 days]
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Length of hospital stay
[Time Frame: The whole hospitalization]
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Length of ICU stay
[Time Frame: Whole hospitalization]
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Nosocomial infection rate
[Time Frame: 28 days]
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Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection)
[Time Frame: 28 days]
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sepsis-associated death
[Time Frame: 28 days]
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Secondary ID(s)
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PRO_Protocol01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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