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Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections (IGNITE4)

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ClinicalTrials.gov Identifier: NCT02784704
Recruitment Status : Completed
First Posted : May 27, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Tetraphase Pharmaceuticals, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Complicated Intra-abdominal Infections Complicated Appendicitis Drug: Eravacycline Drug: Meropenem Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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 Meropenem in Complicated Intra-abdominal Infections
Actual Study Start Date : October 13, 2016
Actual Primary Completion Date : May 8, 2017
Actual Study Completion Date : July 14, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Meropenem

Arm Intervention/treatment
Experimental: Eravacycline Drug: Eravacycline
Other Name: TP-434

Drug: Placebo
Active Comparator: Meropenem Drug: Meropenem
Other Name: Merrem

Drug: Placebo



Primary Outcome Measures :
  1. Number of Participants with a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population [ Time Frame: TOC visit: 25-31 days after first dose of study drug ]

Secondary Outcome Measures :
  1. Number of Participants with a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population [ Time Frame: TOC visit: 25-31 days after first dose of study drug ]
  2. Number of Participants with a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population [ Time Frame: TOC visit: 25-31 days after first dose of study drug ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784704


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Sponsors and Collaborators
Tetraphase Pharmaceuticals, Inc.
Investigators
Study Director: Chief Medical Officer Tetraphase Pharmaceuticals

Responsible Party: Tetraphase Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02784704     History of Changes
Other Study ID Numbers: TP-434-025
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Infection
Communicable Diseases
Appendicitis
Intraabdominal Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Meropenem
Thienamycins
Anti-Bacterial Agents
Anti-Infective Agents