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Compares treatment options for Ventilator-associated Pneumonia
Official title Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients with Ventilator Associated-pneumonia
ClinicalTrials.gov ID: NCT03581370
What this study is testing
What is 1 hour infusion?
1 hour infusion is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ventilator-associated pneumonia.
Also referred to as Zerbaxa 1 g/0.5 g powder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.