BL Infusion Trial: Beta-lactam Continuous Versus Intermittent Infusion and Associated Bacterial Resistance and Therapy Outcomes in Critically Ill Patients With Severe Pneumonia

  • STATUS
    Recruiting
  • End date
    Dec 13, 2023
  • participants needed
    240
  • sponsor
    University of Florida
Updated on 13 March 2022
pneumonia
fever
mechanical ventilation
chest radiograph
respiratory failure
cough
beta-lactam
assisted ventilation

Summary

The study plans to randomize a total of 240 patients infected with Gram-negative bacterial pneumonia to receive beta-lactam (meropenem, cefepime, or piperacillin/tazobactam) continuous or intermittent infusion and collect baseline and regular follow-up respiratory cultures to assess the development of new resistance. The investigators will measure beta-lactam concentration to assess the impact of drug exposure on the bacterial resistance.

Details
Condition Pneumonia
Treatment Cefepime, Meropenem, or Piperacillin/Tazobactam
Clinical Study IdentifierNCT05102162
SponsorUniversity of Florida
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Admission to the medical ICU with severe pneumonia defined as per IDSA/ATS 2019 criteria on mechanical ventilation: presence of signs, symptoms and confirmatory chest imaging consistent with pneumonia (e.g. fever, cough and pulmonary infiltrate by chest radiograph) requiring mechanical ventilation due to respiratory failure
Age ≥18 years
Positive rapid identification test and respiratory culture for Gram-negative bacteria including, but not limited to, P. aeruginosa, K. pneumoniae, E. coli, S. marcescens, H. influenzae, Enterobacter spp., M. catarrhalis, A. baumannii, Achromobacter spp., P. mirabilis, and/or B. cepacia
Received within the last 48 hours or will receive meropenem, cefepime, or piperacillin/tazobactam therapy

Exclusion Criteria

Pregnancy
Prisoners
Allergy to the beta-lactams to be administered in this study
On renal replacement therapy at the time of randomization
Gram-negative bacteria identified by rapid testing only with negative respiratory culture at baseline
COVID patients enrolled in other trials
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note