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

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

Completed

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Key information

Conditions

Bacteremia by Enterobacteriaceae Bacteremia Bacterial Infections Bacterial Infections and Mycoses Disease Attributes Disease Susceptibility Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

>17 years old
Clinically significant bacteremia
Have received treatment fulfilling all this criteria:

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
First antibiotic dose was administered during the first 12 hours after the time of sampling
The antibiotic dosage was at least the advised amount in the summary of product characteristics to patient renal function
The same antibiotic has been administered during at least 48 hours.

Exclusion criteria

Treatment and study plan

Microbiological studies

Other

Primary outcomes

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

Time frame: 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.

Time frame: 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

Time frame: 36 months

Evaluate if piperacillin/tazobactam serum concentrations are correlated with prognosis based on clinical sensitive cut-off points by CLSI and EUCAST

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza Progreso y Salud

Other

Registry information

Official study 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

Acronym: BACTERIEMIA

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Dec 9, 2013
Registry last updated: Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed