Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tetraphase Pharmaceuticals, Inc
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections
