Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-15

Study Completion Date

2022-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimization Dose Study on Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients

NCT02408185

Critical Illness

COMPLETED PHASE1

Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients with Ventilator Associated-pneumonia

NCT03581370

Ventilator-associated Pneumonia

RECRUITING PHASE3

Ceftolozane-tazobactam for the Treatment of Respiratory Infections Due to Extensively Drug-resistant Pseudomonas Aeruginosa Among Critically Ill Patients: a Retrospective Study.

NCT04352855

Ventilator Associated Pneumonia Antibiotic Resistant Infection

UNKNOWN

Plasma Pharmacokinetics (PK) & Lung Penetration of Ceftolozane/Tazobactam in Participants With Pneumonia (MK-7625A-007)

NCT02387372

Critically Ill Pneumonia

COMPLETED PHASE1

Clinical Outcomes With Ceftolozane-tazobactam for MDR Pseudomonas Infections

NCT03510351

Pseudomonas Infections Pseudomonas Aeruginosa

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Serious Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Ceftolozane/tazobactam

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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:

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No