Clinical Trials to Reduce the Risk of Antimicrobial Resistance

Exclusion Criteria

• •Subjects with pneumonia caused by pathogens resistant to meropenem (MIC greater than or equal to 16µg/ml) or a prior meropenem therapy failure.
• •Subjects with contra-indications to ANY study medication, in particular with known or suspected allergy or hypersensitivity.
• •Women who are pregnant or lactating.
• •Subjects taking anticonvulsant medications for a known seizure disorder.Patients with a history of seizures, AND who are stabilized on anti-seizure medication, may be enrolled into the study at the discretion of the site investigator.
• •Subjects with known or suspected community acquired bacterial pneumonia (CABP) or viral pneumonia; or Subjects with acute exacerbation of chronic bronchitis without evidence of pneumonia.
• •Subjects with primary lung cancer or another malignancy metastatic to the lungs.
• •Subjects who were previously enrolled in this study.
• •Subjects who have had an investigational drug or have used an investigational device within 30 days prior to entering the study.
• •Subjects with another focus of infection requiring concurrent antibiotics that would interfere with evaluation of the response to study drug.
• •Subjects with cystic fibrosis, AIDS with a CD4 lymphocyte count \<200 cells/µl, neutropenia (absolute neutrophil count \<500 cells/ml), known or suspected active tuberculosis.
• •Subjects with little chance of survival for the duration of study therapy.
• •Subjects with an APACHE II score \>35.
• •Subjects with underlying condition(s) which would make it difficult to interpret response to the study drugs.
• •Subjects who have undergone bone marrow transplantation.
• •Subjects with profound hypoxia as defined by a PaO2/FiO2 ratio \<100.