Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients

Overview

The aim of this study is to determine the Ceftolozane-Tazobactam Plasmatic Levels and and analyse the clinical impact that might have the dose regimens that have been used until now.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 15, 2021

Interventions

  • Drug: Ceftolozane/tazobactam
    • The dose will be 1g ceftolozane + 0,5 g tazobactam every 8 hours or 2 g ceftolozane + 1 g tazobactam, it´s recommended to use this last dose regimen in patients with pneumonia or septic shock of any focus. The patients will be followed as it´s done habitually. There will be done infection focus cultures and others according to usual clinical practice. It´ll be determined the clinical response and mortality in the days 14 and 30 after the beginning of the medicine, respectively. The Ceftolozane-Tazobactam levels determination will always be made in state of equilibrium (after the third dose). Four samples will be collected: Just before the antibiotic infusion. One hour after the antibiotic infusion. Three hours after the antibiotic infusion. Six hours after the antibiotic infusion.

Arms, Groups and Cohorts

  • Ceftolozane-Tazobactam cohort
    • Patients older than 18 years old that are hospitalised in the Virgen Macarena University Hospital that are being treated with Ceftolozane-Tazobactam in empiric or targeted treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Determine the Ceftolozane-Tazobactam seric concentrations and analyse the clinic impact that could have the dose regimens used until now.
    • Time Frame: Up to 12 months after the antibiotic administration
    • Determination of the Ceftolozane-Tazobactam seric concentration by collecting 4 blood samples and measuring its antibiotic levels and if it´s achieved an adequate therapeutic efficacy assessed by the patient´s clinical and microbiological recovery. The dose regimens used until now are 1+0,5 g every 8 hours in case of intra-abdominal infection or complicated urinary infection and 2 +1 g every 8 hours in case of pneumonia or septic shock of any focus.

Secondary Measures

  • Analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with renal hyper clearance.
    • Time Frame: Up to 12 months after the antibiotic administration
    • Determine if with both dose regimens are achieve the pharmacodynamic and pharmacokinetic parameters associated with the maximum therapeutic efficacy in patients that have creatinine clearance above 130 ml/min.
  • Determine the Ceftolozane-Tazobactam seric concentrations and analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with morbid obesity.
    • Time Frame: Up to 12 months after the antibiotic administration
    • Determination of the Ceftolozane-Tazobactam seric concentration by collecting 4 blood samples and measuring its antibiotic levels and if with both dose regimens are achieve the pharmacodynamic and pharmacokinetic parameters associated with the maximum therapeutic efficacy in patients that have BMI (body mass index) above 40
  • Determine the Ceftolozane-Tazobactam seric concentrations and analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with continuous renal replacement technique.
    • Time Frame: Up to 12 months after the antibiotic administration
    • Determination of the Ceftolozane-Tazobactam seric concentration by collecting 4 blood samples and measuring its antibiotic levels and if with both dose regimens are achieve the pharmacodynamic and pharmacokinetic parameters associated with the maximum therapeutic efficacy in patients that have their blood purified extracorporeally, replacing the renal function continuously 24 hours of the day.
  • Determine if in patients with Gram-negative bacillary bacteremia are achieved concentrations that are 100 % of the time 4 times above the minimum inhibitory concentration (MIC).
    • Time Frame: Up to 12 months after the antibiotic administration
    • Determination of if in patients with Gram-negative bacillary bacteremia (patients with their bloodstream invaded by Gram-negative bacillary which is diagnosed by blood culture) are achieved concentrations that are 100 % of the time 4 times above the MIC by strips of isolated pathogen gradient .
  • Determine by a Monte Carlo simulation model the dose regimen that should be used.
    • Time Frame: Up to 12 months after the antibiotic administration
    • Determination by a Monte Carlo simulation model of the dose regimen that should be used based on the pharmacokinetic parameters and according to the defined efficacy pharmacodynamic parameters.
  • Describe the frequency of resistance´s development during the Ceftolozane-Tazobactam treatment and, if it´s possible to evaluate if there´s a correlation with the seric levels.
    • Time Frame: Up to 12 months after the antibiotic administration
    • Description of the rate of resistance´s development during the Ceftolozane-Tazobactam and if there´s a correlation with the Ceftolozane-Tazobactam seric levels.
  • Describe the Ceftolozane-Tazobactam treatment´s clinical result as well as existence of adverse effects.
    • Time Frame: Up to 12 months after the antibiotic administration
    • Description of the Ceftolozane-Tazobactam clinical results as well as the rate and seriousness of adverse effects.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients older than 18 years old.
  • Hospitalised for a serious illness.
  • Treated with Ceftolozane-Tazobactam
  • Patients that signed the Informed Consent.

Exclusion Criteria

  • Allergic to any component of Ceftolozane-Tazobactam.
  • Any surgical or medical evidence that according to the investigator could interfere with the pharmacodynamics of the medication: absorption, distribution, metabolism or excretion.
  • Concomitant terminal illness.
  • Unable to sign the Informed Consent.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • José Garnacho Montero, Principal Investigator, Hospital Universitario Virgen Macarena
  • Overall Contact(s)
    • María Luisa Cantón Bulnes, 955 00 80 00, luisabulnes@hotmail.com

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