Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections
NCT ID: NCT01844856
Last Updated: 2022-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
541 participants
INTERVENTIONAL
2013-08-31
2014-08-31
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, 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.
Eravacycline
Placebo
Administered IV to maintain the blind.
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.
Ertapenem
Placebo
Administered IV to maintain the blind.
Interventions
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Eravacycline
Ertapenem
Placebo
Administered IV to maintain the blind.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
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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Patrick T Horn, MD, PhD
Role: STUDY_DIRECTOR
Tetraphase Pharmaceuticals, Inc
Locations
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Florence, Alabama, United States
Mobile, Alabama, United States
Glendale, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Torrance, California, United States
Aurora, Illinois, United States
Carmel, Indiana, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Minneapolis, Minnesota, United States
Las Vegas, Nevada, United States
Camden, New Jersey, United States
Teaneck, New Jersey, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Weston, Ohio, United States
Houston, Texas, United States
Seattle, Washington, United States
Córdoba, , Argentina
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Brno, , Czechia
Kladno, , Czechia
Mělník, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
Kohtla-Järve, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Paris, , France
Heidelberg, , Germany
Lübeck, , Germany
Magdeburg, , Germany
Daugavpils, , Latvia
Liepāja, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Timișoara, , Romania
Kaluga, , Russia
Kemerovo, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Smolensk, , Russia
Tomsk, , Russia
Volgograd, , Russia
Vsevolozhsk, , Russia
Benoni, , South Africa
Johannesburg, , South Africa
Pretoria, , South Africa
Worcester, , South Africa
Dnipropetrovsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Odesa, , Ukraine
Uzhhorod, , Ukraine
Zaporizhia, , Ukraine
Countries
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References
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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.
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 J, Evans D, Slepavicius A, Lee P, Marsh A, Tsai L, Sutcliffe JA, Horn P. Assessing the Efficacy and Safety of Eravacycline vs Ertapenem in Complicated Intra-abdominal Infections in the Investigating Gram-Negative Infections Treated With Eravacycline (IGNITE 1) Trial: A Randomized Clinical Trial. JAMA Surg. 2017 Mar 1;152(3):224-232. doi: 10.1001/jamasurg.2016.4237.
Other Identifiers
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TP-434-008
Identifier Type: -
Identifier Source: org_study_id
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