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

Condition(s) targeted: Complicated Intra-abdominal Infections

Intervention: Eravacycline (Drug); Ertapenem (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Tetraphase Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Patrick T. Horn, MD, PhD, Study Director, Affiliation: Tetraphase Pharmaceuticals, Inc.

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).

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical response of eravacycline and ertapenem treatment arms at the test-of-cure (TOC) visit in the microbiological intent-to-treat (micro-ITT) population

Secondary outcome:

Clinical response of eravacycline and ertapenem treatment arms at the end-of-treatment (EOT), TOC, and follow-up(FU) visits

Microbiologic response of eravacycline and ertapenem treatment arms at the EOT and TOC visits

Assess safety and tolerability of eravacycline (Adverse Events, Physical Exams, Vital signs, ECGs, Lab Data) in the safety population

Explore pharmacokinetic parameters after eravacycline infusion

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male or female subject hospitalized for complicated intra-abdominal infection 2. At least 18 years of age (and not over 65 years of age for subjects 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 (e. g., 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 HIV positivity (requiring anti-retroviral therapy or with CD4 count <300), AIDS, organ (bone marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroids (e. g., > 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-h during the 72-h preceding enrollment (however, subjects with documented cIAI (i. e., known baseline pathogen) who have received at least 72-h 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-h 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 TOC visit

Hospital Nuestra Senora de la Misericordia, Cordoba, Argentina

Hospital San Roque, Cordoba, Argentina

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, First Surgery Clinic, Pleven, Bulgaria

Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Surgery Department, Plovdiv, Bulgaria

University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Anesthesiology and Intensive Care Clinic, Plovdiv, Bulgaria

Multiprofile Hospital for Active Treatment, Ruse, Department of Intensive Care of Surgical Diseases, Rousse, Bulgaria

University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Anesthesiology and Intensive Care Clinic, Sofia, Bulgaria

Multiprofile Hospital for Active Treatment, Varna at Military Medical Academy, Anesthesiology, Hyperbaric and Intensive Medicine Clinic, Varna, Bulgaria

University Hospital Brno, Surgery Clinic, Brno, Czech Republic

Regional Hospital Kladno, Inc., Surgery Department, Kladno, Czech Republic

Hospital Melnik, Deparment of Surgery, Melnik, Czech Republic

University Hospital Olomouc, Surgery Intensive Care Department, Olomouc, Czech Republic

Hospital Na Bulovce, Surgery Clinic, Prague, Czech Republic

University Hospital Kralovske Vinohrady, Surgery Clinic, Prague, Czech Republic

University Hospital Motol, Surgery Clinic, Prague, Czech Republic

Masaryk's Hospital Usti Nad Labem, o.z., Surgery Clinic, Usti nad Labem, Czech Republic

East Viru Central Hospital, Surgery Clinic, Kohtla-Jarve, Estonia

East Tallinn Central Hospital, Surgery Clinic, Center for General and Oncology Surgery, Tallinn, Estonia

North Estonia Medical Center Foundation, Surgery Clinic, Center for General and Oncology Surgery, Tallinn, Estonia

Tartu University Hospital, Surgery Clinic, Department of Abdominal Surgery, Tartu, Estonia

Hospital Cochin, Department of Anesthesiology - Resuscitation, Paris, France

University Clinical Center Heidelberg, Heidelberg, Germany

University Hospital Schleswig-Holstein, Clinic of Surgery, Luebeck, Germany

Otto von Guericke University of Magdeburg, University Clinic of General, Visceral and Vascular Surgery, Magdeburg, Germany

Daugavpils Regional Hospital, II Surgery Department, Daugavpils, Latvia

Liepajas Regional Hospital, Department of Surgery, Liepaja, Latvia

P. Stradins Clinical University Hospital, Clinic of Surgery, Riga, Latvia

Riga East University Hospital, LLC, Department of Surgery, Riga, Latvia

Kaunas Republican Hospital, Kaunas, Lithuania

Klaipeda Republican Hospital, Klaipeda, Lithuania

Klaipeda University Hospital, Klaipeda, Lithuania

Siauliai Republican Hospital, Surgery Department #1, Siauliai, Lithuania

Vilnius City Clinical Hospital, Department of Abdominal Surgery, Vilnius, Lithuania

Bucharest University Emergency Hospital, Department of General Surgery IV, Bucharest, Romania

Emergency Clinical Hospital "Bagdasar-Arseni", Bucharest, Romania

Emergency Clinical Hospital "Sf. Pantelimon", Bucharest, Romania

Floreasca Emergency Clinical Hospital, Department of Surgery I, Bucharest, Romania

Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor", Department of Surgery III, Cluj-Napoca, Romania

Craiova Emergency Clinical County Hospital, Department of Surgery III, Craiova, Romania

Timisoara Emergency Clinical County Hospital, Department of Surgery II, Timisoara, Romania

Kaluga Regional Hospital, Kaluga, Russian Federation

Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation

Bauman City Clinical Hospital #29, Moscow, Russian Federation

City Clinical Hospital #13, Moscow, Russian Federation

City Clinical Hospital #24, Moscow, Russian Federation

Filatov City Clinical Hospital #15, Moscow, Russian Federation

City Hospital #33, Nizhny Novgorod, Russian Federation

Smolensk Regional Clinical Hospital, Smolensk, Russian Federation

First Pavlov State Medical University of St. Petersburg, St.Petersburg, Russian Federation

Leningrad Regional Clinical Hospital, St.Petersburg, Russian Federation

Tomsk Regional Clinical Hospital, Tomsk, Russian Federation

City Clinical Hospital of Emergency Medical Care #25, Volgograd, Russian Federation

Vsevolozhsk Clinical Interdistrict Hospital, Vsevolozhsk, Russian Federation

Worthwhile Clinical Trials, Lakeview Hospital, Research Department, Benoni, South Africa

Chris Hani Baragwanath Hospital, Johannesburg, South Africa

Steve Biko Academic Hospital, Critical Care Department, Pretoria, South Africa

Clinical Projects Research, Worcester, South Africa

Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital, Department of Septicopyemic Surgery, Dnipropetrovsk, Ukraine

Ivano-Frankivsk City Clinical Hospital #1, Department of Surgery, Ivano-Frankivsk, Ukraine

Kharkiv City Clinical Hospital #2, Surgery Department #2, Kharkiv, Ukraine

Kyiv City Clinical Hospital #4, Surgery Clinic, Kyiv, Ukraine

Kyiv Regional Clinical Hospital, Kyiv, Ukraine

Odesa Regional Clinical Hospital, Odesa, Ukraine

Uzhhorod Central City Clinical Hospital, Surgery Department #2, Uzhhorod, Ukraine

Zaporizhia City Multispecialty Clinical Hospital #9, Zaporizhia, Ukraine

Eliza Coffee Memorial Hospital, Florence, Alabama, United States

Horizon Research Group, LLC, Mobile, Alabama, United States

Glendale Adventist Medical Center, Glendale, California, United States

Sharp Grossmont Hospital, La Mesa, California, United States

Cedars-Sinai Medical Center, Los Angeles, California, United States

Harbor-UCLA Medical Center, Los Angeles Biomedical Research Institute, Torrance, California, United States

University of Colorado Anschutz Outpatient Pavilion, Aurora, Illinois, United States

Infectious Disease of Indiana, PSC, Carmel, Indiana, United States

St. Elizabeth's Medical Center, Boston, Massachusetts, United States

Baystate Medical Center, Springfield, Massachusetts, United States

Infectious Diseases Minneapolis, Ltd., Minneapolis, Minnesota, United States

Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States

Cooper University Hospital, Camden, New Jersey, United States

Holy Name Medical Center, Teaneck, New Jersey, United States

MetroHealth Medical Center, Cleveland, Ohio, United States

Ohio State University Wexner Medical Center, Columbus, Ohio, United States

Cleveland Clinic Florida, Weston, Ohio, United States

Baylor College of Medicine, Houston, Texas, United States

University of Washington Medical Center, Seattle, Washington, United States

Starting date: August 2013
Last updated: July 21, 2014