efficacy and safety study of eravacycline compared with meropenem in complicated intra-abdominal infections

Conditions: Complicated Intra-abdominal Infections; Complicated Appendicitis

Summary: 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