Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI) (NCT03358576) | Clinical Trial Compass
CompletedPhase 3
Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)
United States674 participantsStarted 2018-09-18
Plain-language summary
This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin-metronidazole for treatment of complicated intra-abdominal infections in adults.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient or the patient's legally acceptable representative able to provide a signed written informed consent prior to any study-specific procedures.
✓. Adult patients ≥18 years of age
✓. EITHER:
✓. Evidence of systemic inflammatory indicators, with at least one of the following:
✓. Physical findings or symptoms consistent with intra-abdominal infection, with at least one of the following:
✓. Specimen/s from the surgical intervention were sent for culture.
Exclusion criteria
✕. Patient diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which the primary etiology was not likely to be infectious.
✕. Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation.
✕. Patient has simple cholecystitis or gangrenous cholecystitis without rupture, or simple appendicitis, or acute suppurative cholangitis; or infected necrotizing pancreatitis or pancreatic abscess.
✕. Patient whose surgery included staged abdominal repair, or "open abdomen" technique, or marsupialization.
✕. Patient known at study entry to have a complicated intra-abdominal infection caused by pathogens resistant to the study antimicrobial agents.
✕. Patient needed effective concomitant systemic antibacterials (oral, IV, or intramuscular) or antifungals in addition to those designated in the 2 study groups, except vancomycin, linezolid, or daptomycin if started for known or suspected methicillin-resistant Staphylococcus aureus (MRSA) or Enterococcus spp. as per clinical study protocol (CSP).
✕. Patient has perinephric infections or an indwelling peritoneal dialysis catheter.
✕. Patient has suspected intra-abdominal infections due to fungus, parasites (e.g., amoebic liver abscess), virus, or tuberculosis.