Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients

NCT04257812 | Unknown

• 1 other identifier: FIS-CEF-2019-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Serious Infection

Keywords

Ceftolozane-Tazobactam; Plasmatic Levels; Serious Infection; Dose adjustment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Analyse if with both dose regimens are achieved the PK/PD parameters associated with the maximum therapeutic efficacy in patients with renal hyper clearance.

  Up to 12 months after the antibiotic administration

• 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.

  Up to 12 months after the antibiotic administration

• 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.

  Up to 12 months after the antibiotic administration

• 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).

  Up to 12 months after the antibiotic administration

• Determine by a Monte Carlo simulation model the dose regimen that should be used.

  Up to 12 months after the antibiotic administration

Study Arms (1)

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.

Drug: Ceftolozane/tazobactam

Interventions

Ceftolozane/tazobactam DRUG

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: 1. Just before the antibiotic infusion. 2. One hour after the antibiotic infusion. 3. Three hours after the antibiotic infusion. 4. Six hours after the antibiotic infusion.

Ceftolozane-Tazobactam cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Interventions

ceftolozane, tazobactam drug combination

Study Officials

• José Garnacho Montero

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Luisa Cantón Bulnes

CONTACT

955 00 80 00; luisabulnes@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: February 15, 2020
• Primary Completion: March 15, 2021
• Study Completion: June 15, 2022
• Last Updated: February 6, 2020

Record last verified: 2020-01

Locations

ES (1)