Clinical trial NCT04257812: Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients
Official title: Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Serious Infection
Keywords: Ceftolozane-Tazobactam
Plasmatic Levels
Serious Infection
Dose adjustment
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years old, hospitalised in the Virgen Macarena University Hospital for a serious infection that meet all the inclusion criteria and none of the exclusion criteria.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine the Ceftolozane-Tazobactam seric concentrations and analyse the clinic impact that could have the dose regimens used until now.
timeFrame: Up to 12 months after the antibiotic administration
Secondary outcomes:
measure: Analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with renal hyper clearance.
timeFrame: Up to 12 months after the antibiotic administration
measure: 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.
timeFrame: Up to 12 months after the antibiotic administration
measure: 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.
timeFrame: Up to 12 months after the antibiotic administration
measure: 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).
timeFrame: Up to 12 months after the antibiotic administration
measure: Determine by a Monte Carlo simulation model the dose regimen that should be used.
timeFrame: Up to 12 months after the antibiotic administration
measure: 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.
timeFrame: Up to 12 months after the antibiotic administration
measure: Describe the Ceftolozane-Tazobactam treatment´s clinical result as well as existence of adverse effects.
timeFrame: Up to 12 months after the antibiotic administration
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: José Garnacho Montero
role: PRINCIPAL_INVESTIGATOR
References: