Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections (IGNITE1)

December 21, 2021 updated by: Tetraphase Pharmaceuticals, Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

541

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina
  • Bulgaria
      • Pleven, Bulgaria
      • Plovdiv, Bulgaria
      • Rousse, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Czechia
      • Brno, Czechia
      • Kladno, Czechia
      • Melnik, Czechia
      • Olomouc, Czechia
      • Prague, Czechia
      • Usti nad Labem, Czechia
  • Estonia
      • Kohtla-Jarve, Estonia
      • Tallinn, Estonia
      • Tartu, Estonia
  • France
      • Paris, France
  • Germany
      • Heidelberg, Germany
      • Luebeck, Germany
      • Magdeburg, Germany
  • Latvia
      • Daugavpils, Latvia
      • Liepaja, Latvia
      • Riga, Latvia
  • Lithuania
      • Kaunas, Lithuania
      • Klaipeda, Lithuania
      • Siauliai, Lithuania
      • Vilnius, Lithuania
  • Romania
      • Bucharest, Romania
      • Cluj-Napoca, Romania
      • Craiova, Romania
      • Timisoara, Romania
  • Russian Federation
      • Kaluga, Russian Federation
      • Kemerovo, Russian Federation
      • Moscow, Russian Federation
      • Nizhny Novgorod, Russian Federation
      • Smolensk, Russian Federation
      • St. Petersburg, Russian Federation
      • Tomsk, Russian Federation
      • Volgograd, Russian Federation
      • Vsevolozhsk, Russian Federation
  • South Africa
      • Benoni, South Africa
      • Johannesburg, South Africa
      • Pretoria, South Africa
      • Worcester, South Africa
  • Ukraine
      • Dnipropetrovsk, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kyiv, Ukraine
      • Odesa, Ukraine
      • Uzhhorod, Ukraine
      • Zaporizhia, Ukraine
  • United States
    • Alabama
      • Florence, Alabama, United States
      • Mobile, Alabama, United States
    • California
      • Glendale, California, United States
      • La Mesa, California, United States
      • Los Angeles, California, United States
      • Torrance, California, United States
    • Illinois
      • Aurora, Illinois, United States
    • Indiana
      • Carmel, Indiana, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Springfield, Massachusetts, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Camden, New Jersey, United States
      • Teaneck, New Jersey, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Weston, Ohio, United States
    • Texas
      • Houston, Texas, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eravacycline, 1.0 mg/kg q12h
Eravacycline was administered intravenously (IV) at a dose of 1.0 milligram per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days. Eravacycline treatment was to be stopped when symptoms of complicated intra-abdominal infection (cIAI) resolved, there was treatment failure, or the maximum allowed number of infusion days was reached.
Drug: Eravacycline
Other Names:
  • TP-434
Drug: Placebo
Administered IV to maintain the blind.
Active Comparator: Ertapenem, 1.0 g q24h
Ertapenem was administered IV at a dose of 1.0 gram (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days. Ertapenem treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached.
Drug: Placebo
Administered IV to maintain the blind.
Drug: Ertapenem
Other Names:
  • Invanz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 visit: 25-31 days after the first dose of study drug
Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
TOC visit: 25-31 days after the first dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit
Time Frame: TOC visit: 25-31 days after first dose
Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
TOC visit: 25-31 days after first dose
Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit
Time Frame: TOC visit: 25-31 days after first dose
Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
TOC visit: 25-31 days after first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tetraphase Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-434-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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