Clinical trial NCT02493764 (phase 3, status: completed)
Conditions: bacterial pneumonia
ICD codes: J15.9, P23.6
Drugs: imipenem, relebactam, cilastatin, piperacillin, tazobactam, linezolid
SMILES: [H][C@]12CC(SCC\N=C\N)=C(N1C(=O)[C@]2([H])[C@@H](C)O)C(O)=O, OS(=O)(=O)ON1[C@H]2C[N@]([C@@H](CC2)C(=O)NC2CCNCC2)C1=O, CC1(C)C[C@@H]1C(=O)N\C(=C/CCCCSC[C@H](N)C(O)=O)C(O)=O, [H][C@]12SC(C)(C)[C@@H](N1C(=O)[C@H]2NC(=O)[C@H](NC(=O)N1CCN(CC)C(=O)C1=O)C1=CC=CC=C1)C(O)=O, [H][C@@]12CC(=O)N1[C@@H](C(O)=O)[C@](C)(CN1C=CN=N1)S2(=O)=O, CC(=O)NC[C@H]1CN(C(=O)O1)C1=CC(F)=C(C=C1)N1CCOCC1
Eligibility criteria:

        Inclusion Criteria:

          -  Requires treatment with IV antibiotic therapy for hospital-acquired bacterial
             pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP)

          -  Fulfills clinical and radiographic criteria, with onset of criteria occurring after
             more than 48 hours of hospitalization or within 7 days after discharge from a hospital
             (for HABP); or at least 48 hours after mechanical ventilation (for VABP)

          -  Has an adequate baseline lower respiratory tract specimen obtained for Gram stain and
             culture

          -  Has an infection known or thought to be caused by microorganisms susceptible to the IV
             study therapy

          -  Agrees to allow any bacterial isolates obtained from protocol-required specimens
             related to the current infection to be provided to the Central Microbiology Reference
             Laboratory for study-related microbiological testing, long term storage, and other
             future testing

          -  Is not of reproductive potential; or if of reproductive potential agrees to avoid
             impregnating a partner or avoid becoming pregnant, by practicing abstinence or using
             acceptable contraception

        Exclusion Criteria:

          -  Has a baseline lower respiratory tract specimen Gram stain that shows the presence of
             Gram-positive cocci only

          -  Has confirmed or suspected community-acquired bacterial pneumonia (CABP)

          -  Has confirmed or suspected pneumonia of viral, fungal or parasitic origin

          -  Has HABP/VABP caused by an obstructive process, including lung cancer or other known
             obstruction

          -  Has a carcinoid tumor or carcinoid syndrome

          -  Has active immunosuppression defined as either receiving immunosuppressive medications
             or having a medical condition associated with immunodeficiency

          -  Is expected to survive for less than 72 hours

          -  Has a concurrent condition or infection that would preclude evaluation of therapeutic
             response

          -  Has received effective antibacterial drug therapy for the index infection of HABP/VABP
             for more than 24 hours continuously, during the previous 72 hours

          -  Has a history of serious allergy, hypersensitivity or a serious reaction to any
             penicillin or beta-lactamase inhibitors

          -  Female is pregnant, expecting to conceive, is breastfeeding or plans to breastfeed

          -  Has a history of seizure disorder requiring ongoing prior treatment with
             anti-convulsive therapy within the last 3 years

          -  Anticipates treatment with the following: valproic acid or divalproex sodium,
             serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin receptor
             antagonists, meperidine, buspirone, concomitant systemic antibacterial agents,
             antifungal or antiviral therapy for the index infection of HABP/VABP

          -  Is currently undergoing hemodialysis or peritoneal dialysis

          -  Is currently participating in, has participated in during the previous 30 days, or
             anticipates to participate in any other clinical study involving the administration of
             experimental medication

          -  Has previously participated in this study