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 (BACTERIEMIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Fundación Pública Andaluza Progreso y Salud
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT02005159
First received: November 14, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Bacteremia by Enterobacteriaceae
Other: Microbiological studies

Study Type: Observational
Study Design: 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

Further study details as provided by Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Correlation between the MIC of different antibiotics and the prognosis in patients with bacteremia. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluate if piperacillin/tazobactam serum concentrations are correlated with prognosis based on clinical sensitive cut-off points by CLSI and EUCAST


Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 900
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Positive blood-culture to bacteremia by enterobacteria
Patients with positive blood-culture to bacteremia by enterobacteria
Other: Microbiological studies

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005159

Contacts
Contact: Jesús Rodríguez Baño 955 00 80 00
Contact: María del Mar Benjumea Vargas gestionensayosclinicos.fps@juntadeandalucia.es

Locations
Spain
Hospital Universitario de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Contact: Carmen Peña Miralles         
Principal Investigator: Carmen Peña Miralles         
Hospital Son Espases Recruiting
Palma de Mallorca, Mallorca, Spain
Contact: Antonio Oliver Palomo         
Principal Investigator: Antonio Oliver Palomo         
Sub-Investigator: Núria Borrell Solé         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Benito Almirante Grajera         
Principal Investigator: Benito Almirante Grajera         
Sub-Investigator: Roger Sordé Masip         
Hospital Clínic Recruiting
Barcelona, Spain
Contact: José Mensa Pueyo         
Principal Investigator: José Mensa Pueyo         
Sub-Investigator: Nazaret Cobos Trigueros         
Sub-Investigator: José Antonio Martínez Martínez         
Sub-Investigator: Alejandro Soriano Viladomiu         
Sub-Investigator: Yuliya Zboromyrska         
Sub-Investigator: Mª Concepción Melción Soler         
Sub-Investigator: Cristina Pitart Ferré         
Sub-Investigator: Jordi Vila Estapé         
Sub-Investigator: Francesc Marco Reverte         
Sub-Investigator: Manuel Almela Prades         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Mercedes Gurgui Ferrer         
Principal Investigator: Mercedes Gurgui Ferrer         
Hospital Universitario Reina Sofía Recruiting
Córdoba, Spain
Contact: Mª del Rosario Lara Contreras         
Principal Investigator: María del Rosario Lara Contreras         
Sub-Investigator: Manuel Causse del Río         
Complejo Hospitalario Universitario A Coruña Recruiting
La Coruña, Spain
Contact: Mª Cruz Fontecoba Sánchez         
Principal Investigator: Mª Cruz Fontecoba Sánchez         
Hospital San Pedro Recruiting
Logroño, Spain
Contact: José Antonio Oteo Revuelta         
Principal Investigator: José Antonio Oteo Revuelta         
Sub-Investigator: Mercedes Sanz Franco         
Sub-Investigator: Carmen Martín Salas         
Sub-Investigator: Lara García Álvarez         
Hospital Universitario La Paz Recruiting
Madrid, Spain
Contact: Alicia Rico Nieto         
Principal Investigator: Alicia Rico Nieto         
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain
Contact: Rafael Cantón Moreno         
Principal Investigator: Rafael Cantón Moreno         
Sub-Investigator: María Isabel Morosini Reilly         
Sub-Investigator: Adriana Shan Núñez         
Hospital Marqués de Valdecilla Recruiting
Santander, Spain
Contact: Luis Martínez Martínez         
Principal Investigator: Luis Martínez Martínez         
Sub-Investigator: Carlos Ruiz de Alegría Puig         
Hospital Universitario de Valme Recruiting
Sevilla, Spain
Contact: Jesús Gómez Mateos         
Principal Investigator: Jesús Gómez Mateos         
Sub-Investigator: Juan E. Corzo Delgado         
Sub-Investigator: Eva M. León Jiménez         
Hospital Universitario Virgen de la Macarena Recruiting
Sevilla, Spain
Contact: Jesús Rodríguez Baño         
Sub-Investigator: Álvaro Pascual Hernández         
Sub-Investigator: Marina de Cueto López         
Sub-Investigator: Mª Dolores del Toro López         
Sub-Investigator: Miguel Ángel Muniain Ezcurra         
Sub-Investigator: Pilar Retamar Gentil         
Sub-Investigator: Ángel Arenzana Seisdedos         
Sub-Investigator: Pilar Egea López         
Sub-Investigator: Vicente Merino Bohórquez         
Principal Investigator: Jesús Rodríguez Baño         
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain
Contact: José Miguel Cisneros Herreros         
Principal Investigator: José Miguel Cisneros Herreros         
Sub-Investigator: José Antonio Lepe Jiménez         
Sub-Investigator: Mª Jesús Rodríguez Hernández         
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
Principal Investigator: Jesús Rodríguez-Baño Hospital Universitario Virgen de la Macarena
  More Information

Additional Information:
No publications provided

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02005159     History of Changes
Other Study ID Numbers: FPS-ANT-2011-01
Study First Received: November 14, 2013
Last Updated: June 16, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundación Pública Andaluza Progreso y Salud:
Enterobacteria
Bacteremia
Minimum inhibitory concentration
Susceptible
Prognosis

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014