Comparison of Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients with Ventilator Associated-pneumonia to Pseudomonas Aeruginosa in Intensive Care Units

Who is this study for? Patients with ventilator associated-pneumonia
What treatments are being studied? Ceftolozane+Tazobactam
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Service Réanimation Polyvalente - CHU Rangueil
RECRUITING
Toulouse
Contact Information
Primary
Stéphanie RUIZ, MD
ruiz.s@chu-toulouse.fr
0561777032
Backup
Nathalie ROQUES
roques.n@chu-toulouse.fr
Time Frame
Start Date: 2018-09-20
Estimated Completion Date: 2025-02
Participants
Target number of participants: 80
Treatments
Active_comparator: 1 hour infusion
The first group corresponds to 1-hour infusion : First administration of ceftolozane-tazobactam with 2000 mg by infusion for 60 minutes every 8 hours.~24h after this first administration, 7 blood samples will be collected at Hour 24, Hour 25, Hour 26, Hour 28, Hour 30, Hour 32 and Hour 48.
Experimental: 4 hours infusion
The second group corresponds to 4-hours infusion: First administration of ceftolozane-tazobactam with 2000 mg by infusion for 4 hours every 8 hours. 24h after this first administration, 7 blood samples will be collected at Hour 24, Hour 25, Hour 26, Hour 28, Hour 30, Hour 32 and Hour 48.~.
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov