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

Phase 1

• Conditions: Ventilator associated-pneumonia to Pseudomonas aeruginosa in intensive care units; MedDRA version: 20.1Level: LLTClassification code 10052596Term: Nosocomial pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-000059-42-FR
• Lead Sponsor: CHU DE TOULOUSE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified