Clinical trial

Antimicrobial Therapy for Ventilator-associated Pneumonia Among Patients Colonized With Extended-spectrum Beta-lactamase-producing Enterobacteriaceae : Efficacy of a Strategy Using Piperacillin-tazobactam as Empirical Treatment.

Name

CHUBX 2019/27

Description

Antimicrobial resistance is a major threat worldwide and now concerns last-ressource antibiotics such as carbapenems. As the resistance to carbapenems is directly due to their use, their spare has become a public health emergency. Their efficacy in ventilator-associated pneumonia has never been compared to other classes of antibiotics such as piperacillin-tazobactam which can be an alternative to carbapenems.

Trial arms

Trial start

2022-02-16

Estimated PCD

2024-08-01

Trial end

2024-08-01

Status

Recruiting

Treatment

Piperacillin-tazobactam

At the time of ventilator-associated pneumonia diagnosis, patients will receive an initial 4g loading dose of piperacillin-tazobactam with a continuous maintenance dose of 16g per day the first day of treatment. The dose of the piperacillin-tazobactam administered the following days will be adjusted to the renal function. The antimicrobial treatment will be adjusted to the narrower-spectrum agent after the antimicrobial susceptibility determination for a total length of treatment of seven days.

Arms:

Intervention

Size

Primary endpoint

Mortality in Intensive Care Unit (ICU)

at day 28 after inclusion

Eligibility criteria

Inclusion Criteria: * Patient above 18 year-old admitted to intensive care unit * ESBL-E fecal carriage according to current screening recommendations * Suspicion of ventilator-associated pneumonia according to ICU society guidelines Exclusion Criteria: * Septic shock according to Sepsis-3 classification * Neutropenia (neutrophils count \< 500/mm3) * Known fecal carriage of Carbapenemase-producing Enterobacteriaceae or multi-drug resistant A. baumanii during the past 6 months. * Infection with a bacteria resistant to piperacillin-tazobactam during the past 6 months * Treatment with piperacillin-tazobactam in the 10 previous days * Proven hypersensitivity to penicillin or tazobactam * Pregnancy or breastfeeding * Curatorship or guardianship * Prisoners * No health insurance

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2023-07-19

1 organization

1 product

1 indication

Organization

University Hospital Bordeaux

Product

Piperacillin-tazobactam

Indication

Enterobacteriaceae Infections