BACTERIEMIA: 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

Sponsor

Fundación Pública Andaluza Progreso y Salud (Other)

Overall Status

Completed

CT.gov ID

NCT02005159

Collaborator

(none)

1,064

Enrollment

Locations

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bacteremia by Enterobacteriaceae	Other: Microbiological studies

Study Design

Study Type:

Observational

Actual Enrollment :

1064 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Positive blood-culture to bacteremia by enterobacteria Patients with positive blood-culture to bacteremia by enterobacteria	Other: Microbiological studies

Arm

Intervention/Treatment

Positive blood-culture to bacteremia by enterobacteria

Patients with positive blood-culture to bacteremia by enterobacteria

Other: Microbiological studies

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Universitario de Bellvitge	L'Hospitalet de Llobregat	Barcelona	Spain
2	Hospital Son Espases	Palma de Mallorca	Mallorca	Spain
3	Hospital Clínic	Barcelona		Spain
4	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain
5	Hospital Universitario Vall d'Hebron	Barcelona		Spain
6	Hospital Universitario Reina Sofía	Córdoba		Spain
7	Complejo Hospitalario Universitario A Coruña	La Coruña		Spain
8	Hospital San Pedro	Logroño		Spain
9	Hospital Universitario La Paz	Madrid		Spain
10	Hospital Universitario Ramón y Cajal	Madrid		Spain
11	Hospital Marqués de Valdecilla	Santander		Spain
12	Hospital Universitario de Valme	Sevilla		Spain
13	Hospital Universitario Virgen de la Macarena	Sevilla		Spain
14	Hospital Universitario Virgen del Rocío	Sevilla		Spain