study to compare tp-434 and ertapenem in community-acquired complicated intra-abdominal infections

Conditions: Complicated Intra-abdominal Infection

Summary: 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