Clinical trial NCT02005159: 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia by Enterobacteriaceae
Keywords: Enterobacteria
Bacteremia
Minimum inhibitory concentration
Susceptible
Prognosis
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 1064
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bacteremia by Enterobacteriaceae attended in participants Hospitals during the study period

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


Eligibility 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:

Primary outcomes:
measure: Correlation between the MIC of different antibiotics and the prognosis in patients with bacteremia.
timeFrame: 36 months
measure: 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.
timeFrame: 36 months
measure: Correlation between piperacillin/tazobactam serum concentrations and clinical prognosis
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Mallorca
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Jesús Rodríguez-Baño
role: PRINCIPAL_INVESTIGATOR
References: