Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections
IGNITE4
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
1 other identifier
interventional
500
11 countries
54
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2016
Shorter than P25 for phase_3
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedStudy Start
First participant enrolled
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2017
CompletedResults Posted
Study results publicly available
February 18, 2019
CompletedJanuary 6, 2022
December 1, 2021
7 months
May 23, 2016
December 21, 2018
December 16, 2021
Conditions
Outcome Measures
Primary Outcomes (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
Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required. Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI. Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.
TOC visit: 25-31 days after first dose of study drug
Secondary Outcomes (2)
Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population
TOC visit: 25-31 days after first dose of study drug
Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population
TOC visit: 25-31 days after first dose of study drug
Study Arms (2)
Eravacycline
EXPERIMENTALMeropenem
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
- Receipt of meropenem or any other carbapenem, or tigecycline for the current infection, or
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Unknown Facility
Los Angeles, California, United States
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Indianapolis, Indiana, United States
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Las Vegas, Nevada, United States
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Somers Point, New Jersey, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Jihlava, Czechia
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Kladno, Czechia
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Kolín, Czechia
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Prague, Czechia
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Tallinn, Estonia
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Tartu, Estonia
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Viljandi, Estonia
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Võru, Estonia
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Batumi, Georgia
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Kutaisi, Georgia
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Tbilisi, Georgia
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Zugdidi, Georgia
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Győr, Hungary
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Kaposvár, Hungary
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Pécs, Hungary
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Veszprém, Hungary
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Daugavpils, Latvia
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Liepāja, Latvia
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Rēzekne, Latvia
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Riga, Latvia
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Vilnius, Lithuania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Craiova, Romania
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Târgu Mureş, Romania
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Timișoara, Romania
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Arkhangelsk, Russia
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Kaluga, Russia
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Krasnodar, Russia
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Nizhny Novgorod, Russia
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Saint Petersburg, Russia
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Volgograd, Russia
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Vsevolozhsk, Russia
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Dnipro, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
Unknown Facility
Uzhhorod, Ukraine
Unknown Facility
Vinnytsia, Ukraine
Related Publications (2)
Solomkin JS, Gardovskis J, Lawrence K, Montravers P, Sway A, Evans D, Tsai L. IGNITE4: Results of a Phase 3, Randomized, Multicenter, Prospective Trial of Eravacycline vs Meropenem in the Treatment of Complicated Intraabdominal Infections. Clin Infect Dis. 2019 Aug 30;69(6):921-929. doi: 10.1093/cid/ciy1029.
PMID: 30561562RESULTSolomkin JS, Sway A, Lawrence K, Olesky M, Izmailyan S, Tsai L. Eravacycline: a new treatment option for complicated intra-abdominal infections in the age of multidrug resistance. Future Microbiol. 2019 Oct;14:1293-1308. doi: 10.2217/fmb-2019-0135. Epub 2019 Oct 1.
PMID: 31570004DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Development Officer
- Organization
- La Jolla Pharmaceutical Company
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Tetraphase Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2016
First Posted
May 27, 2016
Study Start
October 13, 2016
Primary Completion
May 8, 2017
Study Completion
May 19, 2017
Last Updated
January 6, 2022
Results First Posted
February 18, 2019
Record last verified: 2021-12