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Compares treatment options for Beta Lactam Resistant Bacterial Infection
Official title PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)
ClinicalTrials.gov ID: NCT03671967
What this study is testing
What is Piperacillin/tazobactam?
Piperacillin/tazobactam is an investigational medicine, being studied as a potential treatment for beta lactam resistant bacterial infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- More than 72 hr. elapsed since initial blood culture taken, regardless of the time covering antibiotics were started (up to 72 hrs.).
- Polymicrobial bacteremia. Polymicrobial bacteremia will be defined as either growth of two or more different species of microorganisms in the same...
- Patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode.
- Patients with septic shock at the time of enrollment and randomization, defined as at least 2 measurements of systolic blood pressure \ 15μg/kg/min...
- BSI due to specific infections known at the time of randomization:
- Endocarditis / endovascular infections
See the full eligibility criteria
- 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.
- More than 72 hr. elapsed since initial blood culture taken, regardless of the time covering antibiotics were started (up to 72 hrs.).
- 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...
- Patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode.
- Patients with septic shock at the time of enrollment and randomization, defined as at least 2 measurements of systolic blood pressure \ 15μg/kg/min, adrenalin\>0.1μg/kg/min, noradrenalin\>0.1μg/kg/min, vasopressin any...
- 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 treatment clinical trial
- Imminent death (researcher's assessment of expected death within 48 hrs. of recruitment)
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Surrey, British Columbia, Canada
- St. John's, Newfoundland and Labrador, Canada
- Kingston, Ontario, Canada
- Montreal, Quebec, Canada
- Haifa, Israel, Israel
- Beersheba, Israel
- Jerusalem, Israel
- Kfar Saba, Israel
- Netanya, Israel
- Petah Tikva, Israel
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Surrey, British Columbia, Canada; St. John's, Newfoundland and Labrador, Canada; Kingston, Ontario, Canada; Montreal, Quebec, Canada; Haifa, Israel, Israel and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.