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

Completed

• Conditions: Bacteremia by Enterobacteriaceae

• Registration Number: NCT02005159
• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1064

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between the MIC of different antibiotics and the prognosis in patients with bacteremia.	36 months	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
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.	36 months	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
Correlation between piperacillin/tazobactam serum concentrations and clinical prognosis	36 months	Evaluate if piperacillin/tazobactam serum concentrations are correlated with prognosis based on clinical sensitive cut-off points by CLSI and EUCAST

Trial Locations

Locations (14)

Hospital Universitario de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Mallorca, 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

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

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