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

Recruiting now · Phase 3

Conditions studied: Ventilator-associated Pneumonia

In brief

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.

Key facts

Study ID

NCT03581370

Run by

University Hospital, Toulouse

People needed

80

Starts

2018-09-20

Expected to finish

2025-02-01

Last updated by the study team

2024-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Service Réanimation Polyvalente - CHU Rangueil — Toulouse, France (enrolling)

Full record on ClinicalTrials.gov

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