Comparison of short infusion versus prolonged infusion of ceftolozane-tazobactam among patients with ventilator associated-pneumonia to Pseudomonas aeruginosa in intensive care units

Comparison of short infusion versus prolonged infusion of ceftolozane-tazobactam among patients with ventilator associated-pneumonia to Pseudomonas aeruginosa in intensive care units - CEFTOREA

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000059-42-FR

Enrollment

Registered

2018-04-09

Start date

2018-07-25

Completion date

Unknown

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator associated-pneumonia to Pseudomonas aeruginosa in intensive care units MedDRA version: 20.1 Level: LLT Classification code 10052596 Term: Nosocomial pneumonia System Organ Class: 100000004862

Interventions

Trade Name: ZERBAXA Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 years patients with ventilator associated-pneumonia to Pseudomonas aeruginosa patients hospitalized in intensive care units Pseudomonas aeruginosa susceptible to ceftolozane-tazobactam SAPS II (Simplified Acute. Physiological Score 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion 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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 g three times a day (tid) vs 1-hour infusion of 2 g tid.;Secondary Objective: Compare the average exposition obtained with the current recommendations for the 2 products: ceftolozane and tazobactam Estimate the percentage of patients correctly exposed to the 2 products: ceftolozane and tazobactam Determine if Ceftolozane-Tazobactam 4-hours infusion is linked to an improved bacteriological progression in broncho-alveolar liquid Determine if Ceftolozane-Tazobactam 4-hours infusion is linked to an improved clinical progression Determine alveolar concentration of Ceftolozane-Tazobactam from a sample of the alveolar fluid produced by bronchial fibroscopy between the 24th hour and the 48th hour;Primary end point(s): The primary endpoint is the time that the concentration spends above 5MIC, expressed as a percentage of the time interval between two administrations. The T>5MIC will be determined for each patient from the concentration profile measured over an 8-hour post-administration interval. Since protein binding is low (5MIC will be calculated from the total concentrations. Our study will focus on only Pseudomonas aeruginosa PAVM with a critical MIC of 4 mg/l, T>5MIC will then correspond to a residual serum concentration of 20 mg/l.;Timepoint(s) of evaluation of this end point: For the pharmacokinetic study, 7 blood samples will be collected from 24 hours to 48 hours after the first ZERBAXA® administration.	—

Measure

Time frame

Main Objective: 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 g three times a day (tid) vs 1-hour infusion of 2 g tid.;Secondary Objective: Compare the average exposition obtained with the current recommendations for the 2 products: ceftolozane and tazobactam Estimate the percentage of patients correctly exposed to the 2 products: ceftolozane and tazobactam Determine if Ceftolozane-Tazobactam 4-hours infusion is linked to an improved bacteriological progression in broncho-alveolar liquid Determine if Ceftolozane-Tazobactam 4-hours infusion is linked to an improved clinical progression Determine alveolar concentration of Ceftolozane-Tazobactam from a sample of the alveolar fluid produced by bronchial fibroscopy between the 24th hour and the 48th hour;Primary end point(s): The primary endpoint is the time that the concentration spends above 5*MIC, expressed as a percentage of the time interval between two administrations. The T>5*MIC will be determined for each patient from the concentration profile measured over an 8-hour post-administration interval. Since protein binding is low (5*MIC will be calculated from the total concentrations. Our study will focus on only Pseudomonas aeruginosa PAVM with a critical MIC of 4 mg/l, T>5*MIC will then correspond to a residual serum concentration of 20 mg/l.;Timepoint(s) of evaluation of this end point: For the pharmacokinetic study, 7 blood samples will be collected from 24 hours to 48 hours after the first ZERBAXA® administration.

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Secondary

Measure	Time frame
Secondary end point(s): The percentage of patients with concentrations greater than 5*MIC over an 8-hour post administration interval Bactericidal rate obtained in vitro using the Hollow Fiber device. This rate is determined for broncho-alveolar concentrations estimated in patients with pneumonia acquired during ventilation, Bacteriological evaluation at the end of treatment and on day 15, based on actual bacteriological cure, presumed bacteriological cure, failure or bacterial superinfection to another germ. Percentage of patients recovering or failing at the end of the treatment period The number of days without artificial ventilation at D28, The duration of hospitalization, Survival at D28 The alveolar concentration of Ceftolozane-Tazobactam from a sample of the alveolar fluid produced by bronchial fibroscopy between the 24th hour and the 48th hour.;Timepoint(s) of evaluation of this end point: Depending on the secondary end points, the timepoints will occur: - Beetween the 24th hour and the 48th hour (after the beginning of the first infusion) - En fin de traitement (J7 à J10) - A J15 - A J28	—

Measure

Time frame

Secondary end point(s): The percentage of patients with concentrations greater than 5*MIC over an 8-hour post administration interval Bactericidal rate obtained in vitro using the Hollow Fiber device. This rate is determined for broncho-alveolar concentrations estimated in patients with pneumonia acquired during ventilation, Bacteriological evaluation at the end of treatment and on day 15, based on actual bacteriological cure, presumed bacteriological cure, failure or bacterial superinfection to another germ. Percentage of patients recovering or failing at the end of the treatment period The number of days without artificial ventilation at D28, The duration of hospitalization, Survival at D28 The alveolar concentration of Ceftolozane-Tazobactam from a sample of the alveolar fluid produced by bronchial fibroscopy between the 24th hour and the 48th hour.;Timepoint(s) of evaluation of this end point: Depending on the secondary end points, the timepoints will occur: - Beetween the 24th hour and the 48th hour (after the beginning of the first infusion) - En fin de traitement (J7 à J10) - A J15 - A J28

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Countries

France

Contacts

Public ContactBELLOC AUDREY

CHU DE TOULOUSE

belloc.a@chu-toulouse.fr+330561777032

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026