Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections
Condition: Complicated Intra-abdominal Infections
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Intervention: Eravacycline; Ertapenem; Placebo
Intervention description: Administered IV to maintain the blind.
Intervention MeSH terms: Ertapenem
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 541.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female participant hospitalized for cIAI

          2. At least 18 years of age (and not over 65 years of age for participant in India)

          3. Evidence of a systemic inflammatory response

          4. Abdominal pain or flank pain (with or without rebound tenderness), or pain caused by
             cIAI that is referred to another anatomic area

          5. Able to provide informed consent

          6. 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

          7. 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:

          1. Unlikely to survive the 6-8 week study period

          2. Renal failure

          3. Presence or possible signs of hepatic disease

          4. 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)

          5. History of hypersensitivity reactions to tetracyclines, carbapenems, β-lactam
             antibiotics or to excipients contained in the study drug formulations

          6. Participation in any investigational drug or device study within 30 days prior to
             study entry

          7. Known or suspected current Central Nervous System disorder that may predispose to
             seizures or lower seizure threshold

          8. Previously received eravacycline in a clinical trial

          9. Antibiotic-related exclusions:

               1. 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

               2. Receipt of ertapenem or any other carbapenem, or tigecycline for the current
                  infection or

               3. Need for concomitant systemic antimicrobial agents other than study drug

         10. Refusal of mechanical ventilation, dialysis or hemofiltration, cardioversion or any
             other resuscitative measures and drug/fluid therapy at time of consent

         11. Known or suspected inflammatory bowel disease or associated visceral abscess

         12. The anticipated need for systemic antibiotics for a duration of more than 14 days

         13. 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