Bacteremia by Enterobacteriaceae Clinical Trial
— BACTERIEMIAOfficial 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
Provide scientific and validated data to help International Authorities to set susceptible to antibiotics cut-off points in bacteremia by Enterobacteriaceae
| Status | Completed |
| Enrollment | 1064 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 17 Years and older |
| Eligibility |
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: |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| 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 | Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona |
| 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 Son Espases | Palma de Mallorca | Mallorca |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Fundación Pública Andaluza Progreso y Salud |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |