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A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

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Trial Conditions
  • Complicated Intra-abdominal Infections
What is the purpose of this trial?

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).

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

1. Male or female subject hospitalized for complicated intra-abdominal infection

2. At least 18 years of age (and not over 65 years of age for subjects 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
(e.g., 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 HIV positivity (requiring
anti-retroviral therapy or with CD4 count <300), AIDS, organ (bone marrow) transplant
recipients, and hematological malignancy. Immunosuppressive therapy, including use of
high-dose corticosteroids (e.g., > 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-h during the 72-h preceding enrollment (however, subjects with
documented cIAI (i.e., known baseline pathogen) who have received at least 72-h
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-h 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 TOC visit

Gender: Both
Steward Physician(s)
  • Patrick T. Horn, MD, PhD
Trial Interventions
Drug
  • Eravacycline
  • Ertapenem
Physician Researcher

Investigator Name:

  • Patrick T. Horn, MD, PhD

Other Information

Sponsor: Tetraphase Pharmaceuticals, Inc.
Phase: Phase 3
Trial ID: NCT01844856
Volunteers:  Not Accepting Healthy Volunteers

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