NCT03678298

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 19, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

September 17, 2018

Last Update Submit

September 18, 2018

Conditions

Complicated Intra-abdominal Infections

Outcome Measures

Primary Outcomes (2)

  • Mortality rates linked to different sources of infection

    12 months

  • Mortality rates linked to different bacteria causing infection

    12 months

Interventions

Epidemiological/treatment profilesOTHER

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.

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with complicated intra-abdominal infections

You may qualify if:

  • 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)

You may not qualify if:

  • Patients younger than 16 years-old, patients with pancreatitis or primary peritonitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WSES

Bologna, 40139, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiological samples

Study Officials

  • Massimo Sartelli, MD

    WSES

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Sartelli, MD

CONTACT

00393405369701massimosartelli@gmail.com

Fausto Catena, MD

CONTACT

faustocatena@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 19, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

April 1, 2020

Last Updated

September 19, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)