Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections
NCT ID: NCT02784704
Last Updated: 2022-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2016-10-13
2017-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Eravacycline
Eravacycline
Placebo
Meropenem
Meropenem
Placebo
Interventions
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Eravacycline
Meropenem
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tetraphase Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Tetraphase Pharmaceuticals
Locations
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Los Angeles, California, United States
Indianapolis, Indiana, United States
Las Vegas, Nevada, United States
Somers Point, New Jersey, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Jihlava, , Czechia
Kladno, , Czechia
Kolín, , Czechia
Prague, , Czechia
Tallinn, , Estonia
Tartu, , Estonia
Viljandi, , Estonia
Võru, , Estonia
Batumi, , Georgia
Kutaisi, , Georgia
Tbilisi, , Georgia
Zugdidi, , Georgia
Győr, , Hungary
Kaposvár, , Hungary
Pécs, , Hungary
Veszprém, , Hungary
Daugavpils, , Latvia
Liepāja, , Latvia
Rēzekne, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Klaipėda, , Lithuania
Vilnius, , Lithuania
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Târgu Mureş, , Romania
Timișoara, , Romania
Arkhangelsk, , Russia
Kaluga, , Russia
Krasnodar, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Volgograd, , Russia
Vsevolozhsk, , Russia
Dnipro, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Uzhhorod, , Ukraine
Vinnytsia, , Ukraine
Countries
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References
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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.
Solomkin 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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IGNITE4: Results of a Phase 3, Randomized, Multicenter, Prospective Trial of Eravacycline vs. Meropenem in the Treatment of Complicated Intra-Abdominal Infections
Other Identifiers
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TP-434-025
Identifier Type: -
Identifier Source: org_study_id
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