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)

Fundación Pública Andaluza Progreso y Salud

Status: Completed

Conditions: Bacteremia by Enterobacteriaceae

Treatments: Other: Microbiological studies

Study type: Observational

Funder types: Other

Identifiers

NCT02005159

FPS-ANT-2011-01

Details and patient eligibility

About

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

Enrollment: 1,064 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

1,064 participants in 1 patient group

Positive blood-culture to bacteremia by enterobacteria

Description:

Patients with positive blood-culture to bacteremia by enterobacteria

Treatment:

Other: Microbiological studies