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

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ClinicalTrials.gov Identifier: NCT01844856
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Information provided by (Responsible Party):
Tetraphase Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 29, 2013
First Posted Date  ICMJE May 1, 2013
Results First Submitted Date  ICMJE January 26, 2016
Results First Posted Date  ICMJE March 21, 2016
Last Update Posted Date March 21, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2013)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2013)
  • 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 ]
    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 ]
    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 ]
    Describe the safety profile of eravacycline
  • Explore pharmacokinetic parameters after eravacycline infusion [ Time Frame: Day 1 ]
    Evaluate the pharmacokinetics of eravacycline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections
Official Title  ICMJE 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
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Complicated Intra-abdominal Infections
Intervention  ICMJE
  • Drug: Eravacycline
    Other Name: TP-434
  • Drug: Ertapenem
    Other Name: Invanz
  • Drug: Placebo
    Administered IV to maintain the blind.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Eravacycline
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Ertapenem
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 29, 2016)
541
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2013)
536
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Czech Republic,   Estonia,   France,   Germany,   Latvia,   Lithuania,   Romania,   Russian Federation,   South Africa,   Ukraine,   United States
Removed Location Countries India
 
Administrative Information
NCT Number  ICMJE NCT01844856
Other Study ID Numbers  ICMJE TP-434-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tetraphase Pharmaceuticals, Inc.
Study Sponsor  ICMJE Tetraphase Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Patrick T. Horn, MD, PhD Tetraphase Pharmaceuticals, Inc.
PRS Account Tetraphase Pharmaceuticals, Inc.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP