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

Inclusion Criteria:

- Abdominal pain/discomfort with onset prior to hospitalization

- Evidence of a systemic inflammatory response

- Physical findings consistent with intra-abdominal infection (IAI)

- Clinical diagnosis of community-acquired IAI requiring urgent surgical or
percutaneous intervention and not expected to require antibacterial therapy for
longer than 14 days

- Body mass index (BMI) of ≤ 30 kilograms per square meter (kg/m^2)

- Able to provide informed consent. If the participant is unable to provide informed
consent, the participant's legally acceptable representative may provide written
consent in accordance with institutional guidelines

- If female, not pregnant or nursing or, if of child-bearing potential either: will
commit to use at least two medically accepted, effective methods of birth control
(for example, condom, oral contraceptive, indwelling intrauterine device, hormonal
implant/patch, injections, approved cervical ring) during study drug dosing and for
90 days following last study drug dose or practicing sexual abstinence

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