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IT001-303


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
617-636-9094
More Information https://www.clinicaltrials.gov/ct2/show/NCT03358576

Overview

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.