NCT02005159|Completed
Study of the Impact of the Minimum Inhibitory Concentration and Susceptible Cut-off Points (CLSI, EUCAST, and Pharmacokinetics/Pharmacodynamics)in Prognosis of Bacteremia by Enterobacteriaceae
BACTERIEMIA
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BACTERIEMIA
Sponsor study identifier
observational
1,064
1 country
14
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Provide scientific and validated data to help International Authorities to set susceptible to antibiotics cut-off points in bacteremia by Enterobacteriaceae
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 14, 2013
Actual (reported)December 9, 2013
Actual (reported)December 2014
Actual (reported)December 2014
Actual (reported)Correlation between the MIC of different antibiotics and the prognosis in patients with bacteremia.
Study the correlation between the minimum inhibitory concentration (MIC) of cefotaxime, ceftriaxone, cefepime, amoxicillin/clavulanic, piperacillin/tazobactam, ertapenem, imipenem, meropenem, ciprofloxacin and levofloxacin and the prognosis in patients with bacteremia by enterobacteria, with or without mechanisms of resistance
36 months
Correlation between CLSI and EUCAST cut-off points, FC/FD cut-off points with clinical prognosis and of the microbiological response in patients with bacteremia.
Determine if the CLSI and EUCAST (European Committee on Antimicrobial Susceptibility Testing) sensitive clinical cut-off points, as well as the suggested by pharmacokinetic and pharmacodynamic studies (FC/FD) are properly independent predictors of clinical prognosis and of the microbiological response in patients with bacteremia
36 months
Correlation between piperacillin/tazobactam serum concentrations and clinical prognosis
Evaluate if piperacillin/tazobactam serum concentrations are correlated with prognosis based on clinical sensitive cut-off points by CLSI and EUCAST
36 months
Patients with positive blood-culture to bacteremia by enterobacteria
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with bacteremia by Enterobacteriaceae attended in participants Hospitals during the study period
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Son Espases
Palma de Mallorca, Mallorca, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Clínic
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Whole blood
Jesús Rodríguez-Baño
Hospital Universitario Virgen Macarena
1,064 participants (actual enrollment reported by the registry).
First Submitted
November 14, 2013
First Posted
December 9, 2013
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Hospital San Pedro
Logroño, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Marqués de Valdecilla
Santander, Spain
Hospital Universitario de Valme
Seville, Spain
Hospital Universitario Virgen de la Macarena
Seville, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
August 7, 2015
Record last verified: 2015-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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