Piperacillin Tazobactam Versus Meropenem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae- a Non-inferiority Randomized Controlled Trial

Who is this study for? Adult patients with Beta Lactam-Resistant Bacterial Infection
What treatments are being studied? Piperacillin
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Data regarding optimal treatment for extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae blood-stream infection are lacking. Observational studies show conflicting results when comparing treatment with combination beta-lactam-beta-lactamase inhibitor and carbapenems. The investigators aim to evaluate the effect of definitive treatment with meropenem vs. piperacillin-tazobactam on the outcome of patients with bacteremia due to cephalosporin-non-susceptible Enterobacteriaceae. The investigators hypothesize that piperacillin-tazobactam is non-inferior to meropenem.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (age ≥ 18 years)

• New onset BSI due to E. coli or Klebsiella spp. in one or more blood cultures associated with evidence of infection.

• 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).

• Both community and hospital-acquired bacteremias will be included.

• 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.

Locations
Other Locations
Canada
University of Calgary, Cumming School of Medicine, O'Brien Institute for Public Health
RECRUITING
Calgary
Kingston General Hospital
RECRUITING
Kingston
Jewish Genral Hospital
RECRUITING
Montreal
McGill University Health Centre
RECRUITING
Montreal, Quebec
Eastern Health
RECRUITING
St. John's
Surrey Memorial Hospital - Fraser Health Authority
RECRUITING
Surrey
Israel
Soroka Medical Center
RECRUITING
Beersheba
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfar Saba
Sanz Medical Center-Laniado Hospital
RECRUITING
Netanya
Rabin Medical Center, Beilinson Campus
RECRUITING
Petah Tikva
Sheba Medical Center (Tel HaShomer)
RECRUITING
Tel Aviv
Sourasky Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Mical Paul, MD
m_paul@rambam.health.gov.il
972-4-7772991
Backup
Roni Bitterman, MD
ro_oren@rambam.health.gov.il
972-4-7772991
Time Frame
Start Date: 2019-05-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 1084
Treatments
Experimental: piperacillin tazobactam
Active_comparator: meropenem
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Rabin Medical Center, The Chaim Sheba Medical Center, Hadassah Medical Organization, McGill University Health Centre/Research Institute of the McGill University Health Centre, Tel Aviv Medical Center, Jewish General Hospital, Meir Medical Center, University of Modena and Reggio Emilia, Soroka University Medical Center
Leads: Rambam Health Care Campus

This content was sourced from clinicaltrials.gov