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Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients

NCT04257812 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2020-02-06

No results posted yet for this study

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

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: 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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • José Garnacho Montero · Hospital Universitario Virgen Macarena

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2021-03-15
Completion
2022-06-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04257812 on ClinicalTrials.gov