Serious Infection Clinical Trial
Official title:
Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients
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.
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | June 15, 2022 |
| Est. primary completion date | March 15, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario Virgen Macarena | Sevilla |
| Lead Sponsor | Collaborator |
|---|---|
| Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determine the Ceftolozane-Tazobactam seric concentrations and analyse the clinic impact that could have the dose regimens used until now. | 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. |
Up to 12 months after the antibiotic administration | |
| Secondary | Analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with renal hyper clearance. | 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. | Up to 12 months after the antibiotic administration | |
| Secondary | 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. | 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 | Up to 12 months after the antibiotic administration | |
| Secondary | 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. | 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. | Up to 12 months after the antibiotic administration | |
| Secondary | 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). | 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 . | Up to 12 months after the antibiotic administration | |
| Secondary | Determine by a Monte Carlo simulation model the dose regimen that should be used. | 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. | Up to 12 months after the antibiotic administration | |
| Secondary | 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. | Description of the rate of resistance´s development during the Ceftolozane-Tazobactam and if there´s a correlation with the Ceftolozane-Tazobactam seric levels. | Up to 12 months after the antibiotic administration | |
| Secondary | Describe the Ceftolozane-Tazobactam treatment´s clinical result as well as existence of adverse effects. | Description of the Ceftolozane-Tazobactam clinical results as well as the rate and seriousness of adverse effects. | Up to 12 months after the antibiotic administration |