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

ConditionVentilator-associated Pneumonia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 1 hour infusion

    Drug

    Intravenous administration of ceftolozane-tazobactam (ZERBAXA®) : 2000 mg by infusion for 60 minutes every 8 hours.

  • 4 hours infusion

    Drug

    Intravenous administration of ceftolozane-tazobactam (ZERBAXA®) : 2000 mg by infusion for 4 hours every 8 hours

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: 1 hour infusionActive comparator 1 intervention
Group B: 4 hours infusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time that the concentration spends above 5 Minimum inhibitory Concentration (T>5*MIC)

The primary endpoint is the time that the concentration spends above 5\* Minimum inhibitory Concentration, expressed as a percentage of the time interval between two administrations. The T\>5\* Minimum inhibitory Concentration will be determined for each patient from the concentration profile measured over an 8-hour post-administration interval. Since protein binding is low (\<20%), the total concentration (sum of free form and plasma protein bound) will be used as a marker for free concentration. Therefore, the T\>5\* Minimum inhibitory Concentration will be calculated from the total concentrations. Our study will focus on only Pseudomonas aeruginosa Pneumonia acquired under mechanical ventilation with a critical Minimum inhibitory Concentration of 4 mg/l, T\>5\* Minimum inhibitory Concentration will then correspond to a residual serum concentration of 20 mg/l.

Time frame
Time between two administrations (8 hours)

Secondary outcomes

1

Percentage of patients with concentrations greater than 5*Minimum inhibitory Concentration

The percentage of patients with concentrations greater than 5\*Minimum inhibitory Concentration over an 8-hour post administration interval.

Time frame
Time between two administrations (8 hours)
2

Bactericidal rate

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

Time frame
at Day 10
3

Percentage of patients recovering at the end of the treatment period

Number of patients recovering in relation to the total number of patients

Time frame
at Day 10
4

Percentage of patients failing at the end of the treatment period

Number of patients failing in relation to the total number of patients

Time frame
at Day 10

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov
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