Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients With Ventilator Associated-pneumonia (CEFTOREA)

  • STATUS
    Recruiting
  • End date
    Feb 17, 2023
  • participants needed
    80
  • sponsor
    University Hospital, Toulouse
Updated on 17 June 2022
ceftolozane/tazobactam
tazobactam
pseudomonas infections

Summary

The main objective of this study is to compare the median exposures at pharmacokinetic equilibrium of the two modalities of administration: 4-hours infusion of ceftolozane-tazobactam at a dosage of 2 gram three times a day vs 1-hour infusion of 2 gram three times a day.

Description

Intensive care unit patients with ventilator associated-pneumonia often develop severe and rapidly life threatening Gram-negative Bacillus infections. Moreover, they present pathophysiological disturbances responsible for major pharmacokinetic changes (volume of distribution and glomerular filtration) which may lead to drugs under-exposure. Any delay in management or inadequate antibiotic therapy can have serious consequences in terms of prognosis. The association ceftolozane-tazobactam is an alternative to carbapenems in documented infections. Ceftolozane is a new cephalosporin, marketed, in combination with tazobactam (beta-lactamase inhibitor) under the name ZERBAXA®. ZERBAXA® is active on Gram-negative Bacillus, including Pseudomonas aeruginosa.

This is a prospective, randomized, open pharmacokinetic/pharmacodynamic study that compares two modalities of administration of a novel antibiotic, ZERBAXA® ceftolozane-tazobactam, by 4-hours infusion at the dosage of 2 gram three times a day vs. 1-hour infusion at the dosage of 2 g three times a day, among patients with ventilator associated-pneumonia to Pseudomonas aeruginosa.

The patient will be randomized either in the 4-hours or in the 1-hour infusion group. Follow up visits are daily for any intensive care patient. Those provided for biomedical research are carried out during the treatment period, at Day 15 and Day 28. For the pharmacokinetic study, 7 blood samples will be collected from 24 hours to 48 hours after the first ZERBAXA® administration.

Details
Condition Ventilator-associated Pneumonia
Treatment 1 hour infusion, 4 hours infusion
Clinical Study IdentifierNCT03581370
SponsorUniversity Hospital, Toulouse
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

patients with ventilator associated-pneumonia to Pseudomonas aeruginosa
patients hospitalized in intensive care units
Pseudomonas aeruginosa susceptible to ceftolozane-tazobactam
Simplified Acute Physiological Score II (SAPS II () > 20
Expected duration of survival > 7 days
Informed consent of the patient or, failing that, the patient's close or trustworthy person
Affiliated to a social security scheme or equivalent
Non inclusion criteria
history of allergy to one of the two molecules
history of allergy to betalactamines
Strain Isolated resistant to Ceftolozane-Tazobactam combination
Renal insufficiency with a glomerular filtration rate evaluated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 50 ml/min
Patient on dialysis or under continuous hemodiafiltration
pregnant or nursing women
patient benefiting from a system of legal protection for adults
patient with active immunodepression
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