Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

Exclusion criteria

• ✕. Patients who have a history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment)
• ✕. Patients who need more than 3 systemic antibiotics as part of best available therapy (BAT) for the treatment of the Gram-negative infection (patients with mixed Gram-positive or anaerobic infections may receive appropriate concomitant narrow spectrum antibiotics \[eg, vancomycin, linezolid, metronidazole, clindamycin\])
• ✕. Patients with coinfection caused by invasive aspergillosis, mucormycosis or other highly lethal mold
• ✕. Patients who have central nervous system (CNS) infection (eg, meningitis, brain abscess, shunt infection)
• ✕. Patients with infection requiring \> 3 weeks of antibiotic treatment (eg, bone and joint infection, endocarditis)
• ✕. Patients with cystic fibrosis or moderate to severe bronchiectasis
• ✕. Patients in refractory septic shock defined as persistent hypotension despite adequate fluid resuscitation or despite vasopressive therapy at the time of Randomization
• ✕. Patients with severe neutropenia, ie, polymorphonuclear neutrophils (PMNs) \< 100 cells/μL