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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )
ClinicalTrials.gov Identifier:
NCT02005159
First received: November 14, 2013
Last updated: August 4, 2015
Last verified: August 2015
  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 Andalusian Initiative for Advanced Therapies - 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


Enrollment: 1064
Study Start Date: March 2011
Study Completion Date: December 2014
Primary Completion Date: December 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

Locations
Spain
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
Hospital Marqués de Valdecilla
Santander, Spain
Hospital Universitario de Valme
Sevilla, Spain
Hospital Universitario Virgen de la Macarena
Sevilla, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
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: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( 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: August 4, 2015
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:
Enterobacteria
Bacteremia
Minimum inhibitory concentration
Susceptible
Prognosis

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Cisplatin
Ifosfamide
Mitomycin
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2015