NCT lookup

PLATFORM INCLUSION CRITERIA

Platform Inclusion Criteria:

* admitted to a participating hospital
* positive blood culture with Gram negative (GN) bacterium

Platform Exclusion Criteria:

* patient's goals of care are for palliation with no active treatment
* moribund patient, not expected to survive \> 72 hours
* previously enrolled in the platform trial
* not eligible for any domain at the time of screening

DOMAIN SPECIFIC INCLUSION AND EXCLUSION CRITERIA

1. De-escalation versus no de-escalation domain

   Inclusion Criteria

   \- included in BALANCE+ platform

   Exclusion Criteria
   * receiving an empiric antibiotic regimen at the time of blood culture finalization to which the GN pathogen(s) are not sensitive
   * arbapenem-non-susceptible
   * no de-escalation option due to any or all of:

     * antimicrobial resistance
     * allergies
     * medical contraindications
     * drug-drug interaction risk
     * other relevant reason
   * patients with a suspected or proven polymicrobial source of infection
   * \> 24 hours since index blood culture susceptibility results finalization
2. Beta-lactam versus non-beta-lactam oral/enteral treatment domain

   Inclusion Criteria
   * included in BALANCE+ platform
   * initially treated with intravenous antibiotics, but clinical team transitioning patient to oral/enteral antibiotic within 7 days of starting treatment

   Exclusion Criteria
   * enrolled in an arm of another BALANCE+ platform domain which limits the use of oral/enteral therapy:
   * no-de-escalation arm (patients in the no de-escalation arm cannot be randomized into this domain unless they are ready for discharge home, in which case de-escalation is allowable to oral agents at discharge)
   * no non-beta-lactam options due to any or all of:

     * resistance
     * allergies
     * medical contraindications
     * drug-interaction risk
     * other relevant reason
   * no beta-lactam options due to any or all of:

     * resistance
     * allergies
     * medical contraindications
     * drug-interaction risk
     * other relevant reason
   * pregnancy
   * already received \>24 hours of oral antibiotics after index blood culture finalization
3. Central vascular catheter replacement domain

   Inclusion Criteria
   * included in BALANCE+ platform
   * has an indwelling central vascular catheter that was already in place within the 48-hour period before the onset of bloodstream infection (i.e. is not a new catheter placed within 48 hours of the onset of infection)

   Exclusion Criteria
   * patient has no ongoing need for a central vascular catheter
   * patient has definite indication for central vascular catheter removal
   * ongoing septic shock with definite/probable line source

     * concomitant S. aureus bacteremia
     * concomitant candidemia
   * local suppurative signs (severe redness, warmth, pain, swelling or fluctuance/collection) necessitating catheter removal, or other clinical evidence of infected line (e.g. imaging/echocardiographic findings)
4. Low-risk AmpC domain

   Inclusion Criteria
   * included in BALANCE+ platform
   * positive blood culture with GN bacterium, of the following species: i. Serratia spp. ii Morganella spp. iii Providencia spp. iv Proteus spp. other than P.mirabilis
   * organism is susceptible to ceftriaxone

   Exclusion Criteria
   * severe allergy to beta-lactams (e.g., type 4 hypersensitivity reaction or DRESS)
   * baseline phenotypic non-susceptiblity to ceftriaxone
   * more than 1 calendar day beyond availability of susceptibility results
5. Follow up blood culture domain

Inclusion Criteria

\- included in BALANCE+ platform

Exclusion Criteria

* patient died or discharged from hospital prior to day 4
* blood culture already collected by the treating team at day 4±1
* \>5 days since index positive blood culture collection
* definite indication for repeat blood culture testing

  * concomitant S. aureus bacteremia
  * concomitant Candidemia
  * clinical suspicion for infective endocarditis

• Kogarah, New South Wales, Australia
• New Lambton, New South Wales, Australia
• Herston, Queensland, Australia
• Redcliffe, Queensland, Australia
• Sunshine Coast, Queensland, Australia
• Clayton, Victoria, Australia
• Murdoch, Western Australia, Australia
• Murdoch, Western Australia, Australia
• Calgary, Alberta, Canada
• Calgary, Alberta, Canada
• Calgary, Alberta, Canada
• Calgary, Alberta, Canada
• Edmonton, Alberta, Canada
• Surrey, British Columbia, Canada
• Vancouver, British Columbia, Canada
• Winnipeg, Manitoba, Canada
• Winnipeg, Manitoba, Canada
• Winnipeg, Manitoba, Canada
• Fredericton, New Brunswick, Canada
• St. John's, Newfoundland and Labrador, Canada
• Mississauga, Ontario, Canada
• North York, Ontario, Canada
• North York, Ontario, Canada
• Ottawa, Ontario, Canada
• St. Catharines, Ontario, Canada
• Toronto, Ontario, Canada
• Toronto, Ontario, Canada
• Toronto, Ontario, Canada
• Toronto, Ontario, Canada
• Toronto, Ontario, Canada
• + 9 more on CT.gov