Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

Inclusion criteria

• Male or female participant hospitalized for cIAI
• At least 18 years of age (and not over 65 years of age for participant in India)
• Evidence of a systemic inflammatory response
• Abdominal pain or flank pain (with or without rebound tenderness), or pain caused by cIAI that is referred to another anatomic area
• Able to provide informed consent
• If male: must agree to use an effective barrier method of contraception during the study and for 90 days following the last dose if sexually active with a female of childbearing potential
• If female, not pregnant or nursing or, if of childbearing 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

• Unlikely to survive the 6-8 week study period
• Renal failure
• Presence or possible signs of hepatic disease
• Immunocompromised condition, including known human immunodeficiency virus (HIV) positivity (requiring anti-retroviral therapy or with CD4 count <300), acquired immune deficiency syndrome (AIDS), organ (bone marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroids (for example, >40 mg prednisone or equivalent per day for greater than 2 weeks)
• History of hypersensitivity reactions to tetracyclines, carbapenems, β-lactam antibiotics or to excipients contained in the study drug formulations
• Participation in any investigational drug or device study within 30 days prior to study entry
• Known or suspected current Central Nervous System disorder that may predispose to seizures or lower seizure threshold
• Previously received eravacycline in a clinical trial
• Antibiotic-related exclusions:

• Receipt of effective antibacterial drug therapy for cIAI for a continuous duration of >24 hours during the 72-hour preceding enrollment (however, participants with documented cIAI [that is, known baseline pathogen] who have received at least 72 hours of antibiotic therapy and are considered treatment failures may be enrolled. Treatment failure is defined as persistent fever and/or clinical symptoms; or the development of a new intra-abdominal abscess after ≥72 hours of antibiotic therapy), or
• Receipt of ertapenem or any other carbapenem, or tigecycline for the current infection or
• Need for concomitant systemic antimicrobial agents other than study drug
• 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
• The anticipated need for systemic antibiotics for a duration of more than 14 days
• Systemic malignancy that required chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the previous 3 months or that is anticipated to begin prior to the Test-of-Cure (TOC) visit