Status:

COMPLETED

CABI: Antibiotic Duration for Complicated Intra-ABdominal Infection

Lead Sponsor:

University of Leeds

Collaborating Sponsors:

The Leeds Teaching Hospitals NHS Trust

Conditions:

Complicated Intraabdominal Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Complicated intra-ABdominal Infections (CABIs) are abdominal infections where there is an abscess inside the abdomen, or a hole (perforation) in an abdominal organ such that infected material e.g. fae...

Detailed Description

Complicated intra-abdominal infection (CABI) extends beyond the hollow viscus of origin into the peritoneal space and is associated with either abscess formation or peritonitis \[Solomkin 2010\]. CABI...

Eligibility Criteria

Inclusion

  • Adults \>18 years
  • The diagnosis of a definite CABI
  • Capable of giving informed consent
  • No practical or clinical barriers to consuming 28 days of antibiotic therapy, which may include consumption of antibiotics at home

Exclusion

  • a CABI diagnosed within the previous year
  • a CABI diagnosed \>6 days prior to screening
  • uncomplicated cholecystitis/cholangitis/gall bladder empyema (no perforation or extra-biliary abscess
  • a skin and soft tissue infection/abscess not communicating with the peritoneal space
  • primary complicated or uncomplicated appendicitis managed surgically
  • intra-abdominal infection associated with pancreatitis, pelvic inflammatory disease, primary (spontaneous) bacterial peritonitis (SBP), continuous ambulatory peritoneal dialysis peritonitis (CAPD peritonitis) and Clostridium difficile infection. concurrent infection requiring more than 10 days of therapy
  • Infection with a highly resistant bacterium such that antibiotic treatment is considered to be a significantly sub-optimal by the treating microbiologist e.g. multi-resistant carbapenemase producing Entrobacteriacea

Key Trial Info

Start Date :

August 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2018

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT03265834

Start Date

August 1 2017

End Date

September 1 2018

Last Update

June 3 2021

Active Locations (1)

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1

Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, United Kingdom, LS1 3EX