BALANCE+ Vanguard Phase

Exclusion Criteria

• •1. patient's goals of care are for palliation with no active treatment
• •2. moribund patient, not expected to survive \> 72 hours
• •(A) DE-ESCALATION VS. NO DE-ESCALATION DOMAIN
• •1. receiving an empiric antibiotic regimen at the time of blood culture finalization to which the GN pathogen(s) are not sensitive
• •2. carbapenem-resistance (so that patients will not need to remain on reserve-use agents)
• •3. no de-escalation option due to any or all of
• •i. resistance ii. allergies iii. medical contraindications iv. drug-interaction risk v. other relevant reason
• •4. patients with a suspected or proven polymicrobial source of infection
• •(B) BETA-LACTAM VS. NON-BETA-LACTAM ORAL/ENTERAL TREATMENT DOMAIN
• •1. enrolled in an arm of another BALANCE+ platform domain which limits the use of oral/enteral therapy
• •\- no-de-escalation arm
• •2. no non-beta-lactam options due to any or all of
• •i. resistance ii. allergies iii. medical contraindications iv. drug-interaction risk v. other relevant reason
• •3. no beta-lactam options due to any or all of
• •i. resistance ii. allergies iii. medical contraindications iv. drug-drug interaction risk v. other relevant reason
• •(C) CENTRAL VASCULAR CATHETER REPLACEMENT DOMAIN
• •1. patient has no ongoing need for a central vascular catheter
• •2. patient has definite indication for central vascular catheter removal
• •1. ongoing septic shock with definite/probable line source
• •2. concomitant S. aureus bacteremia
• •3. concomitant candidemia
• •4. 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)
• •5. definite alternative source of GN BSI
• •(D) LOW-RISK AmpC DOMAIN
• •1. severe allergy to beta-lactams (eg, type 4 hypersensitivity reaction or DRESS)
• •2. baseline phenotypic resistance to ceftriaxone
• •(E) FOLLOW UP BLOOD CULTURE DOMAIN
• •1. patient already discharged home prior to day 4
• •2. definite indication for repeat blood culture testing
• •1. concomitant Staph. aureus bacteremia
• •2. concomitant Candidemia
• •3. clinical suspicion for infective endocarditis (e.g., presence of prosthetic valve, implantable cardiac device)