- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03678298
Italian Register for the Study of Complicated Intra-Abdominal Infections (IRCA)
Italian Register for the Study of Complicated Intra-Abdominal Infections (IRCA) Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objectives of the study are: (1) the identification of specific risk factors for in-hospital mortality, in order to perfect the clinical management of patients with complicated intra-abdominal infections (cIAIs); (2) the identification of specific risk factors for multi-drug resistant organisms (MDROs) isolation in patients with cIAIs, in order to improve the adequacy of empirical antimicrobial therapy.
The secondary objectives are: (1) the description of the clinical, diagnostic and treatment profiles of patients with cIAIs in Italian surgical departments; (2) the analysis of epidemiology and patterns of antimicrobial susceptibility of the microorganisms isolated in samples in intra-operative samples of peritoneal fluid or purulent exudate/discrete abscesses in patients with cIAIs; (3) the identification of specific risk factors for post-operative complications in patients with cIAIs.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Fausto Catena, MD
- Email: faustocatena@gmail.com
Study Contact Backup
- Name: Massimo Sartelli, MD
- Phone Number: 00393405369701
- Email: massimosartelli@gmail.com
Study Locations
-
-
-
Bologna, Italy, 40139
- WSES
-
Contact:
- Massimo Sartelli, MD
- Phone Number: 00393405369701
- Email: massimosartelli@infectionsinsurgery.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
All consecutively hospitalized adult patients (older than 18 years of age) undergoing surgery, interventional drainage or conservative treatment, with diagnosis of cIAIs (defined as abdominal infections originating in an organ cavity, extending into the peritoneal space, and forming an abscess or peritonitis)
Exclusion Criteria:
Patients younger than 16 years-old, patients with pancreatitis or primary peritonitis
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality rates linked to different sources of infection
Time Frame: 12 months
|
12 months
|
Mortality rates linked to different bacteria causing infection
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Massimo Sartelli, MD, WSES
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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