Name: 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
Published: 2026-03-15T22:33:02.720211

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

At least 18 years of age (and not over 65 years of age for participant in India)
Evidence of a systemic inflammatory response
Male or female participant hospitalized for cIAI
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

Criterios de exclusión

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

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Eravacycline

Ertapenem

Placebo

Ubicaciones

Patrocinadores