Complicated intra-abdominal infections
Conditions
Interventions
Experimental group:Eravacycline 1.0 mg/kg IV q 12h
Control group:Ertapenem 1g IV q 24h
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female subject hospitalized for cIAI; 2. Aged at least 18 years; 3. Able to provide informed consent; 4. Evidence of a systemic inflammatory response; 5. Abdominal pain or flank pain (with or without rebound tenderness), or pain caused by cIAI that is referred to another anatomic area, or localized or diffuse abdominal wall rigidity, or mass, or ileus; 6. Subjects agree to use a highly reliable method of birth control; 7. For pre-operation enrollment, radiographic imaging results is required which is congruent with diagnosis of cIAI and acute surgical intervention is foreseen within 24h. For intra-operative/post-operative enrollment, visual confirmation of cIAI during an adequate surgical intervention is required, and the subject must receive no more than 1 dose of effective antibacterial drug post-operatively before randomization.
Exclusion criteria
Exclusion criteria: 1. Considered unlikely to survive the 6-8 week study period; 2. Creatinine clearance of = 30 mL/min; 3. Presence or possible signs of significant hepatic disease; 4. Immunocompromised condition; 5. History of moderate or severe hypersensitivity reactions to study drug or their similar class of drug; 6. Participation in any investigational drug or device study within 30 days prior to randomization; 7. Known or suspected current central nervous system (CNS) disorder that may predispose to seizures; 8. Antibiotic-related exclusions: a. Receipt of effective antibacterial drug therapy for cIAI > 24h during the 72-h preceding randomization (However, Subjects with known baseline pathogen who are considered treatment failure after at least 72-hour of antibiotic therapy may be enrolled.) OR b. Receipt of study drug or the similar class of drug for the current infection, OR c. Need for concomitant systemic antimicrobial agents other than study drug. 9. Refusal of any resuscitative measures and drug/fluid therapy at time of consent; 10. Known or suspected inflammatory bowel disease or associated visceral abscess; 11. The anticipated need for systemic antibiotics for a duration of more than 14 days; 12. Systemic malignancy that required antineoplastic therapy within the previous 3 months or that is anticipated to begin prior to the TOC visit; 13. Known at randomization to have cIAI caused by a pathogen(s) resistant to one of the study drugs; 14. Any other unstable or clinically significant concurrent medical condition; 15. Previously received eravacycline treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological efficacy; | — |
Countries
China
Contacts
Public ContactKevin Li
EverID Medicines (Beijing) Limited
Outcome results
None listed