Comparing 5 approaches for gram-negative bacteremia

Exclusion

• −severe allergy to beta-lactams (e.g., type 4 hypersensitivity reaction or DRESS)
• −patient's goals of care are for palliation with no active treatment
• −moribund patient, not expected to survive \> 72 hours
• −previously enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in the platform trial
• −not eligible for any domain at the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −DOMAIN SPECIFIC INCLUSIONInclusion criteriaThe things you must have or be for a study to consider you.Read more → AND EXCLUSION CRITERIAExclusion criteriaThe things that would prevent someone from taking part.Read more →
• −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
• −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
• −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 armArmOne of the groups in a study, each receiving something different.Read more → 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 randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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
• −medical contraindications
• −drug-interaction risk
• −other relevant reason
• −no beta-lactam options due to any or all of:
• −resistance
• −medical contraindications
• −drug-interaction risk
• −other relevant reason
• −already received \>24 hours of oral antibiotics after index blood culture finalization
• −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)
• −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
• −baselineBaselineYour starting measurements, taken before treatment begins.Read more → phenotypic non-susceptiblity to ceftriaxone
• −more than 1 calendar day beyond availability of susceptibility results
• −Follow upFollow-upContinued check-ins after the treatment part is finished.Read more → 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