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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tetraphase Pharmaceuticals, Inc.
• Treatments: Ertapenem

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