At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Intra-operative or post-operative enrollment with visual confirmation of pus and peritonitis from cholecystitis rupture, diverticular perforation, appendiceal perforation, traumatic bowel perforation (>12 hours post-injury), secondary peritonitis, or intra-abdominal abscess with intraperitoneal involvement
- ✓OR pre-operative enrollment with open laparotomy, percutaneous abscess drainage, or laparoscopic surgery planned within 24 hours before first study drug dose
- ✓At least one systemic inflammatory indicator: fever >38°C, hypothermia <35°C, WBC >12,000/mm³, SBP <90 mmHg without vasopressors, tachycardia >90 bpm AND tachypnea >20 breaths/min, or hypoxia ≤90% on room air
- ✕Traumatic bowel perforation with surgery <12 hours post-injury; gastroduodenal ulcer perforation with surgery <24 hours; or non-infectious primary intra-abdominal processes
- ✕Abdominal wall abscess, bowel obstruction without perforation, or ischemic bowel without perforation
- ✕Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, or pancreatic abscess
- ✕Surgery included staged abdominal repair, open abdomen technique, or marsupialization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of Efiicacy, Tolerability & Safety of Sulopenem & Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro-metronidazole for Treatment of cIAI in Adults
In Brief
A Phase 3 clinical trial evaluating Ertapenem, Sulopenem-Etzadroxil/Probenecid, and 4 other interventions for Intra Abdominal Infections. Completed, enrolled 674 participants across 42 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
Antibiotic for complicated intra-abdominal infection
Antibiotic for complicated intra-abdominal infection
Antibiotic for complicated intra-abdominal infection
Antibiotic for complicated intra-abdominal infection
Antibiotic for complicated intra-abdominal infection
Antibiotic for complicated intra-abdominal infection