Comparing two antibiotics for treating bloodstream infections from resistant bacteria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of piperacillin-tazobactam compared to meropenem in treating bloodstream infections caused by cephalosporin-resistant Enterobacteriaceae. The study focuses on adult patients with new onset bacteremia due to E. coli or Klebsiella spp. and aims to determine if piperacillin-tazobactam is as effective as meropenem. Participants will be monitored for treatment outcomes to assess the non-inferiority of piperacillin-tazobactam. The trial includes both community and hospital-acquired infections.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults (age ≥ 18 years)
2. New onset BSI due to E. coli or Klebsiella spp. in one or more blood cultures associated with evidence of infection.
3. The microorganism will have to be non-susceptible to third generation cephalosporins (ceftriaxone and ceftazidime) and susceptible to both PTZ and meropenem (see microbiological methods).
4. Both community and hospital-acquired bacteremias will be included.
5. We will permit the inclusion of bacteremias due to E. coli or Klebsiella spp. with concomitant growth in blood of skin commensals considered as contaminants.

Exclusion Criteria:

1. More than 72 hr. elapsed since initial blood culture taken, regardless of the time covering antibiotics were started (up to 72 hrs.).
2. Polymicrobial bacteremia. Polymicrobial bacteremia will be defined as either growth of two or more different species of microorganisms in the same blood culture, or growth of different species in two or more separate blood cultures within the same episode.
3. Patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode.
4. Patients with septic shock at the time of enrollment and randomization, defined as at least 2 measurements of systolic blood pressure \< 90 mmHg and/or use of vasopressors (dopamine\>15μg/kg/min, adrenalin\>0.1μg/kg/min, noradrenalin\>0.1μg/kg/min, vasopressin any dose) in the 12 hours prior to randomization. In the absence of the use of vasopressors, a systolic blood pressure \<90 would need to represent a deviation for the patient's known normal blood pressure.
5. BSI due to specific infections known at the time of randomization:

   1. Endocarditis / endovascular infections
   2. Osteomyelitis (not resected)
   3. Central nervous system infections
6. Allergy to any of the study drugs confirmed by history taken by the investigator
7. Previous enrollment in this trial
8. Concurrent participation in another interventional clinical trial
9. Imminent death (researcher's assessment of expected death within 48 hrs. of recruitment)

Where it's running

• University of Calgary, Cumming School of Medicine, O'Brien Institute for Public Health
  Calgary, Alberta, Canada Recruiting
• Surrey Memorial Hospital - Fraser Health Authority
  Surrey, British Columbia, Canada Recruiting
• Eastern Health
  St. John's, Newfoundland and Labrador, Canada Recruiting
• Kingston General Hospital
  Kingston, Ontario, Canada Recruiting
• Jewish Genral Hospital
  Montreal, Quebec, Canada Recruiting
• McGill University Health Centre
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Roni Bitterman, MD — Rambam Health Care Campus
• Study coordinator: Mical Paul, MD
• Email: m_paul@rambam.health.gov.il
• Phone: 972-4-7772991

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Aztreonam-Avibactam in Immunocompromised Patients with Multidrug-Resistant Infections

  This study tests how well and how safely aztreonam-avibactam works in adults with weakened immune systems who have highly resistant Enterobacterales infections.

  Recruiting Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno · Buenos Aires, City of Buenos Aires · NCT07890480

• UllCORE BSI Test for Bloodstream Infections

  This study tests whether the UllCORE BSI Test can correctly detect bloodstream infection pathogens and resistance markers from whole blood in people with suspected infection or sepsis.

  Recruiting Deepull Diagnostics S.L. · Orange, California and 19 other locations · NCT07859852

• Beta-lactam plus levofloxacin for streptococcal bacteremia

  This trial tests whether adding levofloxacin to standard beta-lactam therapy helps adults with streptococcal bacteremia see better outcomes.

  Recruiting at 2 sites Phase 4 Mahidol University · Bangkok and 3 other locations · NCT07240077

• Blood cultures from arterial lines: does it change contamination, bacteremia detection, and how much blood is drawn?

  This study tests whether drawing blood cultures from arterial lines affects contamination rates, how well bacteremia is detected, and the volume of blood collected in ICU patients.

  Recruiting Meir Medical Center · Kfar Saba · NCT07183410

• New care guideline for infants 60 days and younger with fever in Sweden

  This project will test a new guideline to see if infants 60 days or younger with fever can safely avoid many invasive tests, hospital stays, and broad antibiotics compared with usual care.

  Recruiting at 9 sites Region Skane · Gothenburg and 10 other locations · NCT07134751

• GRADY: a computer tool to detect early sepsis and gram-negative bloodstream infection in ICU patients

  The GRADY tool will be tested to see if routine vital signs and lab results can detect early sepsis and gram-negative bloodstream infection in adult ICU patients.

  Recruiting Sisli Hamidiye Etfal Training and Research Hospital · Seyrantepe, Istanbul · NCT07126106

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.