Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections

Exclusion Criteria

• •Symptoms related to diagnosis of complicated appendicitis (if current diagnosis) for \< 24 hours prior to current hospitalization
• •Previously hospitalized or admitted to a healthcare facility within the last 6 months
• •Managed by Staged Abdominal Repair or other open abdomen technique
• •Known at study entry to have an IAI caused by a pathogen(s) resistant to both study drug antibiotics
• •Acute Physiology and Chronic Health Evaluation (APACHE) II score \> 25
• •Unlikely to survive the 6-8 week study period
• •Any rapidly-progressing disease or immediately life-threatening illness, including acute hepatic failure, respiratory failure and septic shock
• •Requirement for vasopressors at therapeutic dosages
• •Renal failure
• •Presence or possible signs of hepatic disease
• •Hematocrit \< 25% or hemoglobin \< 8 grams per deciliter (g/dL)
• •Neutropenia with absolute neutrophil count \< 1000 cells per cubic millimeter (mm\^3)
• •Platelet count \< 50,000/mm3
• •Abnormal coagulation tests or participant on anticoagulants
• •Immunocompromised condition, including known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS), organ (bone marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroids (for example, \> 40 milligrams \[mg\] prednisone or equivalent per day for greater than 2 weeks)
• •History of hypersensitivity reactions to tetracyclines or carbapenems
• •Participation in any investigational drug or device study within 30 days prior to study entry
• •Known or suspected central nervous system (CNS) disorder that may predispose to seizures or lower seizure threshold
• •Previously received TP-434 in a clinical trial
• •More than 24 hours duration of systemic antibiotic coverage for current condition
• •Received ertapenem or any other carbapenem, or tigecycline for the current infection
• •Need for concomitant systemic antimicrobial agents other than study drug or received systemic (IV or oral) antibiotics in the last 3 months
• •Refusal of mechanical ventilation, dialysis or hemofiltration, cardioversion or any other resuscitative measures and drug/fluid therapy at time of consent
• •Known or suspected inflammatory bowel disease or associated visceral abscess