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

This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with meropenem in the treatment of complicated intra-abdominal infections (cIAIs).


Eligibility Criteria:
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