Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal … (NCT01844856) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections
United States541 participantsStarted 2013-08
Plain-language 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 of adult complicated intra-abdominal infections (cIAI).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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)
What they're measuring
1
Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population
Timeframe: TOC visit: 25-31 days after the first dose of study drug
✕. 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