Comparing short and prolonged infusion of an antibiotic for pneumonia in ICU patients
Comparison of Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients with Ventilator Associated-pneumonia to Pseudomonas Aeruginosa in Intensive Care Units
This study is testing whether giving an antibiotic for pneumonia in the ICU over one hour or four hours works better for patients on ventilators.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT03581370 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the pharmacokinetic profiles of two different infusion durations of the antibiotic ceftolozane-tazobactam in patients with ventilator-associated pneumonia caused by Pseudomonas aeruginosa. Patients will be randomized to receive either a 1-hour or a 4-hour infusion of the antibiotic, both at a dosage of 2 grams three times a day. The study will monitor the patients closely in the intensive care unit, with daily follow-ups and blood samples collected to assess drug levels and effectiveness. The goal is to determine which infusion method provides better drug exposure and potentially improves patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include ICU patients diagnosed with ventilator-associated pneumonia due to Pseudomonas aeruginosa who are expected to survive more than 7 days.
Not a fit: Patients with a history of allergy to ceftolozane-tazobactam or those with renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for patients with severe pneumonia, enhancing recovery rates and reducing mortality.
How similar studies have performed: While the specific approach of comparing infusion durations is novel, similar studies have shown promising results with ceftolozane-tazobactam in treating resistant infections.
Eligibility criteria
Show full inclusion / exclusion criteria
inclusion 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 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 this trial is running
Toulouse
- Service Réanimation Polyvalente - CHU Rangueil — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Stéphanie RUIZ, MD — University Hospital, Toulouse
- Study coordinator: Stéphanie RUIZ, MD
- Email: ruiz.s@chu-toulouse.fr
- Phone: 0561777032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.