Pilot randomised controlled trial of meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections.

Phase 4

Recruiting

• Conditions: Participants who have had a bloodstream infection with a specific gram negative bacteria, as defined by at least one positive blood culture, where the isolate is confirmed to be a likely AmpC-producer by resistance to Ampicillin, Amoxicillin/clavulanate and 1st generation cephalosporins (e.g. cephazolin). The isolate should also remain susceptible to piperacillin/tazobactam and meropenem.; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12614001211651
• Lead Sponsor: The University of Queensland Centre for Clinical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

a.Bloodstream infection with Enterobacter spp., Serratia marcescens, Providencia spp., Morganella morganii or Citrobacter freundii (i.e. likely AmpC-producer), and susceptibility to 3rd generation cephalosporins (i.e. ceftriaxone, cefotaxime or ceftazidime), meropenem and piperacillin-tazobactam from at least one blood culture draw. This will be determined in accordance with laboratory methods and susceptibility breakpoints defined by protocols used in the recruiting site laboratories.
b.No more than 72 hours has elapsed since the first positive blood culture collection.
c.Patient is aged 18 years and over (>=21y in Singapore).

Exclusion Criteria

a. Patient not expected to survive more than 4 days
b. Patient allergic to a penicillin or a carbapenem
c. Patient with significant polymicrobial bacteraemia (that is, a Gram positive skin contaminant in one set of blood cultures is not regarded as significant polymicrobial bacteraemia).
d. Treatment is not with the intent to cure the infection (that is, palliative care is an exclusion).
e. Pregnancy or breast-feeding.
f. Use of concomitant antimicrobials in the first 4 days after enrolment with known activity against Gram-negative bacilli (except trimethoprim/sulphamethoxazole may be continued as Pneumocystis prophylaxis).
g. Likely source to be from (proven or suspected at the time of randomisation) the central nervous system, e.g. brain abscess, post-surgical meningitis, shunt infection (due to concerns over CNS penetration of piperacillin/tazobactam)

Study & Design

• Study Type: Interventional
• Study Design: Not specified