Pilot Randomized Control Trial of Meropenem vs. Piperacillin-Tazobactam for definitive treatment of bloodstream infections due to ceftriaxone non-susceptible Escherichia Coli and Klebsiella spp.

Phase 4

Completed

• Conditions: Participants who have had an identified Escherichia Coli or Klebsiella spp. bloodstream infection that is found non-susceptible to Ceftriaxone.; Infection - Other infectious diseases

• Registration Number: ACTRN12613000532707
• Lead Sponsor: Australasian Society of Infectious Diseases Clinical Research Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The primary outcome for the trial is the occurence and confirmation of mortality at 30 days after the first positive blood culture.[30 days post first positive blood culture.]

Secondary Outcome Measures

Name	Time	Method
1. Time to clinical and microbiologic resolution [Number of days from initiation of study drug to resolution of SIRS PLUS sterilisation of blood cultures.];2. Clinical and microbiologic success[Survival at day four after the initation of study drug PLUS resolution of SIRS on or before day four PLUS sterilisation of blood cultures on or before day four.];3. Microbiologic resolution of infection[Sterility of blood cultures on 3rd day post initial recruitment.];4. Microbiologic relapse[Growth of the same organism as in the original blood culture after the end of the period of study drug administration, before 30 days after the first positive blood culture was drawn.]