Status:
COMPLETED
Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections
Lead Sponsor:
Tetraphase Pharmaceuticals, Inc
Conditions:
Complicated Intra-abdominal Infections
Complicated Appendicitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 treat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Antibiotic-related exclusions:
- 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
Key Trial Info
Start Date :
October 13 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2017
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02784704
Start Date
October 13 2016
End Date
May 19 2017
Last Update
January 6 2022
Active Locations (54)
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1
Los Angeles, California, United States
2
Indianapolis, Indiana, United States
3
Las Vegas, Nevada, United States
4
Somers Point, New Jersey, United States