None listed
Conditions
Brief summary
Escherichia coli (“E. coli”) and Klebsiella are bacteria which are common causes of infections in your blood stream. Patients with bloodstream infections due to either E. coli or Klebsiella, can commonly be treated with antibiotics called third generation cephalosporins, such as the antibiotic ceftriaxone. When the blood stream infection is resistant to these antibiotics, the antibiotics meropenem and piperacillin/tazobactam have been shown to be effective alternatives for treatment. The purpose of this study is to work out whether these two other antibiotics, meropenem and piperacillin/tazobactam, are equally effective in the treatment of these antibiotic resistant bloodstream infections. These antibiotics have never been compared “head to head” in order to establish the best available treatment for these serious infections. This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions.
Interventions
Recruited participants will randomly be assigned to either receive the study drugs of Meropenem or Piperacillin-Tazobactam in a 1:1 ratio according to a randomisation list prepared in advance. The intervention treatment for this study is the administration of the drug Piperacillin-Tazobactam 4.5 grams administered every 6 hours intravenously over a 30 minute period. The duration of treatment with this drug will be for a minimum of 4 days and a maximum of 14 days. The duration of the therapy will be determined by the treating clinician.
Sponsors
Australasian Society of Infectious Diseases Clinical Research Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Bloodstream infection with Escherichia coli or Klebsiella spp., as defined by at least one positive blood culture from a peripheral blood draw. 2. Bacteria confirmed as ceftriaxone non-susceptible, Piperacillin-Tazobactam susceptible and Meropenem susceptible by use of EUCAST definitions (www.eucast.org). 3. No more than 72 hours since the first positive blood culture was collected for this infection. 4. Patient or their ethics committee approved proxy able to give written informed consent.
Exclusion criteria
1. Patient not expected to survive more than 4 days. 2. Patient allergic to a penicillin or a carbapenem. 3. Patient with significant polymicrobial bacteraemia (that is, a Gram positive skin containment in one set of blood cultures is not regarded as significant polymicrobial bacteraemia). 4. Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion).
Outcome results
None listed