Italian Register for the Study of Complicated Intra-Abdominal Infections

Complicated Intra-abdominal Infections Clinical Trial

— IRCA  

Official title:

Italian Register for the Study of Complicated Intra-Abdominal Infections (IRCA) Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03678298
• Other study ID #: 1/2018
• Status: Not yet recruiting
• Start date: January 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: August 2018
• Source: World Society of Emergency Surgery
• Contact: Massimo Sartelli, MD
• Phone: 00393405369701
• Email: massimosartelli[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study will identify the epidemiological and treatment profiles of acute peritonitis in Italy

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: April 1, 2020
• Est. primary completion date: January 1, 2020
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Complicated Intra-abdominal Infections
• Infection
• Intraabdominal Infections

Intervention

Other:
• Epidemiological/treatment profiles
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, will be included in the study.

Locations

Country	Name	City	State
Italy	WSES	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
World Society of Emergency Surgery

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rates linked to different sources of infection		12 months
Primary	Mortality rates linked to different bacteria causing infection		12 months