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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tetraphase Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01844856
First received: April 29, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Complicated Intra-abdominal Infections
Drug: Eravacycline
Drug: Ertapenem
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Tetraphase Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Clinical response of eravacycline and ertapenem treatment arms at the test-of-cure (TOC) visit in the microbiological intent-to-treat (micro-ITT) population [ Time Frame: TOC: 25-31 days after the first dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response of eravacycline and ertapenem treatment arms at the end-of-treatment (EOT), TOC, and follow-up(FU) visits [ Time Frame: EOT: within 24 hours of last dose; TOC: 25-31 days after first dose; FU: 38-50 days after first dose ] [ Designated as safety issue: No ]
    Compare clinical response in the following populations: 1) Intent -to-treat (ITT) population, 2) Clinically evaluable (CE) population, 3) Micro-ITT population (for EOT, FU), 4) Microbiologically evaluable (ME) population.

  • Microbiologic response of eravacycline and ertapenem treatment arms at the EOT and TOC visits [ Time Frame: EOT: within 24 hours of last dose; TOC: 25-31 days after first dose ] [ Designated as safety issue: No ]
    Compare the microbiological response in the following populations: 1) Micro-ITT population, 2) ME population.

  • Assess safety and tolerability of eravacycline (Adverse Events, Physical Exams, Vital signs, ECGs, Lab Data) in the safety population [ Time Frame: Screening, Days 1-14, EOT, TOC, FU ] [ Designated as safety issue: Yes ]
    Describe the safety profile of eravacycline

  • Explore pharmacokinetic parameters after eravacycline infusion [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Evaluate the pharmacokinetics of eravacycline


Estimated Enrollment: 536
Study Start Date: August 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eravacycline, 1.0 mg/kg q12h
Eravacycline, 1.0 mg/kg q12h administered via IV infusion, plus saline placebo
Drug: Eravacycline
Eravacycline reconstituted and administered via an IV infusion
Other Name: TP-434
Active Comparator: Ertapenem, 1 g q24h
Ertapenem, 1 g q24h administered via IV infusion, plus saline placebo
Drug: Ertapenem
Ertapenem reconstituted and administered via an IV infusion
Other Name: Invanz®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844856

  Show 84 Study Locations
Sponsors and Collaborators
Tetraphase Pharmaceuticals, Inc.
Investigators
Study Director: Patrick T. Horn, MD, PhD Tetraphase Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Tetraphase Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01844856     History of Changes
Other Study ID Numbers: TP-434-008
Study First Received: April 29, 2013
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infection
Communicable Diseases
Intraabdominal Infections
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014