Status:
COMPLETED
Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections
Lead Sponsor:
Tetraphase Pharmaceuticals, Inc
Conditions:
Complicated Intra-abdominal Infections
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 of eravacycline compared with ertapenem in the treatment ...
Eligibility Criteria
Inclusion
- Male or female participant hospitalized for cIAI
- At least 18 years of age (and not over 65 years of age for participant in India)
- 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 90 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 90 days following last study drug dose or practicing sexual abstinence
Exclusion
- Unlikely to survive the 6-8 week study period
- Renal failure
- Presence or possible signs of hepatic disease
- 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)
- History of hypersensitivity reactions to tetracyclines, carbapenems, β-lactam antibiotics or to 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 disorder that may predispose to seizures or lower seizure threshold
- Previously received eravacycline in a clinical trial
- Antibiotic-related exclusions:
- 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
- Receipt of ertapenem or any other carbapenem, or tigecycline for the current infection or
- Need for concomitant systemic antimicrobial agents 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT01844856
Start Date
August 1 2013
End Date
August 1 2014
Last Update
January 11 2022
Active Locations (69)
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Florence, Alabama, United States
2
Mobile, Alabama, United States
3
Glendale, California, United States
4
La Mesa, California, United States