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

N/ACompletedNCT02005159

Fundación Pública Andaluza Progreso y Salud1,064 enrolled

Overview

Provide scientific and validated data to help International Authorities to set susceptible to antibiotics cut-off points in bacteremia by Enterobacteriaceae

Study Type

OBSERVATIONAL

Enrollment

1,064

Conditions

Bacteremia by Enterobacteriaceae

Interventions

Microbiological studiesOTHER

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \>17 years old * Clinically significant bacteremia * Have received treatment fulfilling all this criteria: 1. Treated with an only active antibiotic with enterobacteria (association with vancomycin, linezolid, daptomycin, metronidazole or clindamycin) between: cefotaxime, ceftriaxone, ceftazidime, cefepime, amoxicillin/clavulanic, piperacillin/tazobactam, ertapenem, imipenem, meropenem, ciprofloxacin or levofloxacin 2. First antibiotic dose was administered during the first 12 hours after the time of sampling 3. The antibiotic dosage was at least the advised amount in the summary of product characteristics to patient renal function 4. The same antibiotic has been administered during at least 48 hours. Exclusion Criteria:

Locations (14)

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 36 months

Data from ClinicalTrials.gov

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