Efficacy of Piperacillin-tazobactam as Empirical Antimicrobial Therapy for VAP Among ESBL-E Carriers.

NCT04276480 | Completed

• 1 other identifier: CHUBX 2019/27
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Enterobacteriaceae Infections

Keywords

Fecal carriage; Ventilator-associated pneumonia; Piperacillin-tazobactam

Outcome Measures

Primary Outcomes (1)

• Mortality in Intensive Care Unit (ICU)

  Proportion of patients who died during ICU stay.

  at day 28 after inclusion

Secondary Outcomes (3)

• Proportion of patients cured of infection on D3 and D7 after inclusion

  at day 7 after inclusion

• Proportion of patients requiring an escalation of the probabilistic treatment of piperacillin-tazobactam to meropenem.

  at day 28 after inclusion

• Mortality at day 90

  at day 90 after inclusion

Study Arms (1)

Intervention

EXPERIMENTAL

The patients included will receive piperacillin-tazobactam as empirical antimicrobial therapy. The empirical microbial therapy will continue until the bacterial susceptibility profile is known.

Drug: Piperacillin-tazobactam

Interventions

Piperacillin-tazobactam DRUG

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

Centre hospitalier de la Côte Basque

Bayonne, 64100, France

Location

Hopital Pellegrin

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Enterobacteriaceae Infections; Pneumonia, Ventilator-Associated

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Laura RICHERT, Dr

  USMR

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 19, 2020
• Study Start: February 16, 2022
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

FR (2)