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

Condition(s) targeted: Bacteremia by Enterobacteriaceae

Intervention: Microbiological studies (Other)

Phase: N/A

Status: Completed

Sponsored by: Fundación Pública Andaluza Progreso y Salud

Official(s) and/or principal investigator(s):
Jesús Rodríguez-Baño, Principal Investigator, Affiliation: Hospital Universitario Virgen de la Macarena

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

Official title: Study of the Impact of the Minimum Inhibitory Concentration and Susceptible Cut-off Points (CLSI, EUCAST and Pharmacokinetic/Pharmacodynamic) in Prognosis of Bacteremia by Enterobacteriaceae

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Correlation between the MIC of different antibiotics and the prognosis in patients with bacteremia.

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.

Correlation between piperacillin/tazobactam serum concentrations and clinical prognosis

Minimum age: 17 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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:

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

Complejo Hospitalario Universitario A Coruña, La Coruña, Spain

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, Sevilla, Spain

Hospital Universitario Virgen de la Macarena, Sevilla, Spain

Hospital Universitario Virgen del Rocío, Sevilla, Spain

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Son Espases, Palma de Mallorca, Mallorca, Spain

Starting date: March 2011
Last updated: August 4, 2015