Complicated Intra-abdominal InfectionsIRCANCT03678298
Italian Register for the Study of Complicated Intra-Abdominal Infections
An observational study of Complicated Intra-abdominal Infections, run by World Society of Emergency Surgery at 1 site in Italy.
Trial summary
The study will identify the epidemiological and treatment profiles of acute peritonitis in Italy Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Complicated Intra-abdominal Infections
- What is being tested?
- Epidemiological/treatment profiles
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 1 Apr 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Adult, Older adult
Study population: All patients with complicated intra-abdominal infections
Who may be able to join
- 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)
Who cannot join
- Patients younger than 16 years-old, patients with pancreatitis or primary peritonitis
Trial locations and contacts
1 site in 1 country.
Fausto Catena, MD contact
Italy1 site
WSES
Bologna, 40139
Massimo Sartelli, MD, 00393405369701, massimosartelli@infectionsinsurgery.org
About this study
Official title: Italian Register for the Study of Complicated Intra-Abdominal Infections (IRCA) Study
The study will identify the epidemiological and treatment profiles of acute peritonitis in Italy
Read the 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.
- Conditions
- Complicated Intra-abdominal Infections
- Being tested
- Epidemiological/treatment profiles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rates linked to different sources of infection
Measured: 12 months
Mortality rates linked to different bacteria causing infection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Intra-abdominal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- World Society of Emergency Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Sartelli, World Society of Emergency Surgery
- Investigators
- Massimo Sartelli, MD, Principal investigator, WSES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678298
- Sponsor's protocol ID
- 1/2018
- Acronym
- IRCA
- Status last verified
- Aug 2018
- First submitted
- 17 Sep 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Register for the Study of Complicated Intra-Abdominal Infections (IRCA) Study
- ClinicalTrials.gov ID
- NCT03678298
- Acronym / sponsor ID
- IRCA / 1/2018
- Conditions
- Complicated Intra-abdominal Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- World Society of Emergency SurgeryUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will identify the epidemiological and treatment profiles of acute peritonitis in Italy
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with complicated intra-abdominal infections
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients younger than 16 years-old, patients with pancreatitis or primary peritonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidemiological/treatment profilesAll 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. | Other | – |
Primary outcome
Mortality rates linked to different sources of infection
Time frame: 12 months
Mortality rates linked to different bacteria causing infection
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fausto Catena, MD contact
Massimo Sartelli, MD principal investigator
WSES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Intra-abdominal Infections, run by World Society of Emergency Surgery at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimo Sartelli, MD (00393405369701, massimosartelli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rates linked to different sources of infection (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.