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

NCT02005159 | Completed

• 1 other identifier: FPS-ANT-2011-01
• Study Type: observational
• Target: 1,064
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Bacteremia by Enterobacteriaceae

Keywords

Enterobacteria; Bacteremia; Minimum inhibitory concentration; Susceptible; Prognosis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Positive blood-culture to bacteremia by enterobacteria

Patients with positive blood-culture to bacteremia by enterobacteria

Other: Microbiological studies

Interventions

Microbiological studies OTHER

Positive blood-culture to bacteremia by enterobacteria

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with bacteremia by Enterobacteriaceae attended in participants Hospitals during the study period

You may qualify if:

• \>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.

Sponsors & Collaborators

• Fundación Pública Andaluza Progreso y Salud: lead

Study Sites (14)

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital Son Espases

Palma de Mallorca, Mallorca, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Location

Hospital Clínic

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital San Pedro

Logroño, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Marqués de Valdecilla

Santander, Spain

Location

Hospital Universitario de Valme

Seville, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Bacteremia; Disease Susceptibility

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Jesús Rodríguez-Baño

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: December 9, 2013
• Study Start: March 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

ES (14)