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Title IT001-303: A prospective Phase 3, double-blind, multicenter, randomized study of the efficacy and safety of sulopenem followed by sulopenem etzadroxil with probenecid versus ertapenem followed by ciprofloxacin and metronidazole or amoxicillin-clavulanate for treatment of complicated intra-abdominal infections in adults. 
Therapeutic Area Intraabdominal Infections
Principal Investigator Yoav Golan, MD, MS
Min Age 18 Years
Gender All
Contact Sedina Dzodzomenyo
More Information


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 

Study Details

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.