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

This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs).


Eligibility Criteria:
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