Phase
Condition
Soft Tissue Infections
Bacterial Infections
Sepsis And Septicemia
Treatment
Piperacillin/tazobactam
Meropenem
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults (age ≥ 18 years)
New onset BSI due to E. coli or Klebsiella spp. in one or more blood culturesassociated 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 (seemicrobiological methods).
Both community and hospital-acquired bacteremias will be included.
We will permit the inclusion of bacteremias due to E. coli or Klebsiella spp. withconcomitant growth in blood of skin commensals considered as contaminants.
Exclusion
Exclusion Criteria:
More than 72 hr. elapsed since initial blood culture taken, regardless of the timecovering antibiotics were started (up to 72 hrs.).
Polymicrobial bacteremia. Polymicrobial bacteremia will be defined as either growthof two or more different species of microorganisms in the same blood culture, orgrowth of different species in two or more separate blood cultures within the sameepisode.
Patients with prior bacteremia or infection that have not completed antimicrobialtherapy for the previous infectious episode.
Patients with septic shock at the time of enrollment and randomization, defined asat least 2 measurements of systolic blood pressure < 90 mmHg and/or use ofvasopressors (dopamine>15μg/kg/min, adrenalin>0.1μg/kg/min,noradrenalin>0.1μg/kg/min, vasopressin any dose) in the 12 hours prior torandomization. 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 bloodpressure.
BSI due to specific infections known at the time of randomization:
Endocarditis / endovascular infections
Osteomyelitis (not resected)
Central nervous system infections
Allergy to any of the study drugs confirmed by history taken by the investigator
Previous enrollment in this trial
Concurrent participation in another interventional clinical trial
Imminent death (researcher's assessment of expected death within 48 hrs. ofrecruitment)
Study Design
Connect with a study center
University of Calgary, Cumming School of Medicine, O'Brien Institute for Public Health
Calgary, Alberta T2N 4Z6
CanadaActive - Recruiting
Surrey Memorial Hospital - Fraser Health Authority
Surrey, British Columbia
CanadaActive - Recruiting
Eastern Health
Saint John's, Newfoundland and Labrador
CanadaActive - Recruiting
Kingston General Hospital
Kingston, Ontario
CanadaActive - Recruiting
Jewish Genral Hospital
Montreal, Quebec H3T 1E2
CanadaActive - Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec,
CanadaActive - Recruiting
Soroka Medical Center
Be'er Sheva,
IsraelActive - Recruiting
Rambam Health Care Campus
Haifa, 3435306
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem,
IsraelActive - Recruiting
Meir Medical Center
Kfar Saba,
IsraelActive - Recruiting
Sanz Medical Center-Laniado Hospital
Netanya, 42150
IsraelActive - Recruiting
Rabin Medical Center, Beilinson Campus
Petah tikva,
IsraelActive - Recruiting
Sheba Medical Center (Tel HaShomer)
Tel Aviv,
IsraelActive - Recruiting
Sourasky Medical Center
Tel Aviv,
IsraelActive - Recruiting

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