Status:
COMPLETED
Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections
Lead Sponsor:
Tetraphase Pharmaceuticals, Inc
Conditions:
Complicated Intra-abdominal Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01265784
Start Date
January 1 2011
End Date
May 1 2012
Last Update
January 6 2022
Active Locations (38)
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1
Long Beach VA Medical Center
Long Beach, California, United States, 90822
2
Denver Health Medical Center
Denver, Colorado, United States, 80204
3
Henry Ford Hospital
Detroit, Michigan, United States, 48202
4
Barnes Jewish Hospital
St Louis, Missouri, United States, 63110