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

Inclusion Criteria:

- Male or female participant hospitalized for cIAI

- At least 18 years of age

- 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 14 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 14 days
following last study drug dose or practicing sexual abstinence

Exclusion Criteria:

- Unlikely to survive the 6-8 week study period

- Creatinine clearance of ≤50 milliliter (mL)/minute

- Presence or possible signs of significant hepatic disease

- Immunocompromised condition, including known human immunodeficiency virus (HIV)
positivity, transplant recipients, and hematological malignancy

- History of moderate or severe hypersensitivity reactions to tetracyclines,
carbapenems, β-lactam antibiotics, or to any of the 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 (CNS) disorder that may predispose
to seizures or lower seizure threshold (for example, severe cerebral arteriosclerosis,
epilepsy)

- Antibiotic-related exclusions:

1. Receipt of effective antibacterial drug therapy for cIAI for a continuous
duration of >24-hours during the 72-hours preceding randomization [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

2. Receipt of meropenem or any other carbapenem, or tigecycline for the current
infection, or

3. Need for concomitant systemic antimicrobial agents effective in cIAI 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

- Known at study entry to have cIAI caused by a pathogen(s) resistant to one of the
study drugs