The purpose of this research study is to determine if IV sulopenem followed by oral sulopenem-etzadroxil/probenecid is safe and at least as effective as standard treatment for complicated intra-abdominal infections
Inclusion Criteria
- Intra-operative/post-operative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
- Pre-operative enrollment where surgical procedures such as open laparotomy, percutaneous drainage of an intra-abdominal abscess, or laparoscopic surgery are planned within 24 hours of the first dose of study drug.
- Physical findings consistent with intra-abdominal infection, such as: Abdominal pain /tenderness, localized or diffuse abdominal wall rigidity, abdominal mass, altered mental status.
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 a known history of serious allergy, hypersensitivity or any serious reaction to carbapenem antibiotics, other β-lactam antibiotics, quinolones, metronidazole, or probenecid.
Study Requirements
- Subjects will be randomized in a 1:1 fashion to receive either sulopenem followed by sulopenem etzadroxil co-administered with oral probenecid or ertapenem followed by ciprofloxacin and metronidazole or amoxicillin-clavulanate.
- The planned study total intervention duration is 28 days with a screening period of up to 1 day, treatment period lasting from day 1 to 10 or 14 days, a follow-up phone call on day 21 and a follow-up visit on Day 28.
- Subjects will receive the drug initially as IV for at least 5 days followed by oral antibiotics to complete 7-10 days of treatment which may be extended up to a maximum of 14 days if required.
At each visit, any or all of the following may be performed:
- Review your health history and ask how you are feeling.
- Administer the study drug.
- Check to see what medications you are taking or any that you have taken recently.
- Perform a physical exam and assess your abdominal infection specific signs and symptoms.
- Check your vital signs (temperature, blood pressure, pulse & respiratory rate).
- Check if you have or have had any side effects (serious or non-serious)
- Collect blood and urine samples
- Collect sample from the site of infection in your abdomen, if applicable.
