A Prospective Study on the Incidence and Risk Factors Related to Infection in Patients With Inflammatory Bowel Disease (INFEII)

July 22, 2020 updated by: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
The purpose of this study is to determine the incidence and risk factors related to Infection in patients with Inflammatory Bowel Disease (IBD)

Study Overview

Status

Completed

Conditions

Detailed Description

IBD could lead to an increased risk of infections, particularly related to immunosuppressive therapy. The true effect of having IBD in the development of infections has not been studied in depth since the cohort studies are scarce and the results of studies with different approaches are contradictory.

The limited time period of former studies may not be enough to assess infectious complications that may occur in a long term period.

Moreover, certain polymorphisms demonstrated to confer a higher risk of opportunistic infections under immunosuppressive conditions, for instance HIV, patients with cystic fibrosis and Candida' infections. For this reason, it seems reasonable to think that genetic factors might play a role in the risk of opportunistic infections in IBD.

The hypothesis of this study is that patients with IBD have an increased risk of infection by immunosuppressive treatment.

TYPE OF STUDY Prospective cohort study that evaluates the effect of immunosuppression and other clinical factors in the onset of infection in IBD

STUDY DESIGN PATIENTS & METHODS This study is aimed to all incidental patients diagnosed with Crohn's disease and ulcerative colitis included in the ENEIDA database.

METHODS An infection would be considered as relevant when: 1) requires hospital admission, 2) leads to death or endangers the patient's life (ICU admission, presence of hemodynamic instability, sepsis, tracheal intubation, vasoactive drug requirement), 3) must be treated with specific antibiotics (antibacterials, antivirals, antifungals) 4) affects recurrently (herpes virus, papilloma virus, etc). 5) requires change/withdrawal of immunosuppressive or biological treatment.

The appearance of relevant infection will be prospectively evaluated, performing a subanalysis at 3 and 5 years using ENEIDA platform. ENEIDA is a database from a Spanish national study in IBD on genetic and environmental determinants run under GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa) supervision. This database basically comprises: demographic characteristics, type of IBD, immunosuppressant treatment, biological treatment or surgery)

At the time of inclusion the following variables should be available (and are mandatory): demographic characteristics, type of IBD, date of diagnosis, phenotypic characteristics of the disease, history of serious infections, information on received treatments particularly the exposure to immunosuppressants, biological treatment or surgery and whether an infection has occurred as a complication of the three treatment groups. It should also be collected the following serologic details: hepatitis type B virus C, HIV, tuberculosis (TB), varicella zoster status.

At the time of registration a blood sample (10cc) will be drawn and sent to a biobank to analyze the DNA for genetic research.

STUDY ANALYSIS Sample calculation

The main objective of this study is to determine the percentage of infections in IBD and the related risk factors for the development of infections in patients with IBD. Given that the reported prevalence of infection varies between 6 and 10%the formula for estimating endless samples, establishing:

  • Security level of the confidence interval at 95%
  • Expected value for the worst case scenario of 6% (prevalence of infection)
  • Precision of 1.5%
  • The minimum sample number is set to 963, and assuming a loss rate of 20%

With these assumptions, the total number of patients to be included is 1204 patients.

The statistical analysis will be in three steps: (1) independent clinical factors analysis, (2) genetic factors infection-related analysis and (3) clinical and genetic factors infection- related analysis.

Baseline and follow up data will be compared among patients who develop infection and those who do not. Quantitative variables will be contrast by T-student and Mann-Whitney test. Qualitative variable will be contrast by X2 or Fisher test. Logistic regression will be conducted to analyze independent associations between variables and Kaplan-Meier test to calculate survival curves.

An analysis of Cox proportional hazards will be conducted to assess the effect of exposure to independent predictors of the risk of significant infection or mortality.

Finally the intensity of the significant associations will be measured by calculating the OR, HR and confidence interval of 95%.

Study Type

Observational

Enrollment (Actual)

1204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Del Mar
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Córdoba, Spain, 14004
        • Hospital Reina Sofia
      • Girona, Spain, 17007
        • Hospital Universitari dr. Josep Trueta
      • Lleida, Spain, 25198
        • Hospital Universitari Arnau de Vilanova
      • Madrid, Spain, 28006
        • Hospital De La Princesa
      • Terrassa, Spain, 08227
        • Consorci Hospitalari de Terrassa
      • Valencia, Spain
        • Hospital Universitari La Fe
      • València, Spain, 46010
        • Hospital Clínic de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Clínico Universitario Lozano Blesa
    • Asturias
      • Oviedo, Asturias, Spain
        • Hospital Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Granollers, Barcelona, Spain, 08402
        • Hospital General de Granollers
      • Hospitalet de Llobregat, Barcelona, Spain
        • Hospital Universitario de Bellvitge
      • Manresa, Barcelona, Spain, 08243
        • Althaia, Xarxa Assistencial Universitària de Manresa
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
      • Sant Joan Despí, Barcelona, Spain, 08970
        • Hospital Moisés Broggi
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Mutua De Terrassa
    • Bilbao
      • Galdakao, Bilbao, Spain
        • Hospital de Galdakao
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Ciudad REAL
      • Tomelloso, Ciudad REAL, Spain, 13700
        • Hospital General de Tomelloso
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital Universitario Fuenlabrada
      • San Sebastián De Los Reyes, Madrid, Spain, 28703
        • Hospital Infanta Sofia
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Complexo Hospital Universitario de Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Incident cases of IBD registered on ENEIDA data base

Description

Inclusion criteria:

  • All incidental patients with IBD controlled at each participating center, registered in the ENEIDA database could be included, until the expected study sample is reached (n=1204 patients).
  • An incidental IBD case is any patient with a diagnosis of Crohn's disease, ulcerative colitis and unclassified colitis after 3-6 month of the conclusive diagnosis of IBD.

Exclusion Criteria:

  • HIV infection or any congenital immunodeficiency at the time of inclusion.
  • To be under any immunosuppressant therapy for another reason other than IBD at IBD diagnosis.
  • No consent to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
IBD patients
Incidental patients with IBD controlled (including Crohn's disease, Ulcerative colitis and unclassified colitis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of infection and type of infection in patients with ulcerative colitis and Crohn's disease, regardless of treatment received. ulcerative colitis and Crohn's disease, regardless of treatment received.
Time Frame: Change from baseline incidence and type of infection at 3 and 5 years

Serious infection means any untoward medical occurrence that at any dose:

  • Results in death or life-threatening
  • Requires in patient hospitalization or prolongation of an existing hospitalization
  • Is a medically important event.
  • Requires specific chemotherapy treatment
  • Emerges repeatedly.
  • Induces a switch or a withdrawal of the immunosuppressive or biological treatment
Change from baseline incidence and type of infection at 3 and 5 years
Clinical, demographic, epidemiologic and genetic factors associated with the risk of infection in patients with IBDassociated with the risk of infection in patients with IBD.
Time Frame: Change from baseline and at 3 and 5 years
Change from baseline and at 3 and 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of duration and immunosuppressive potency in the development of infections
Time Frame: at baseline and at 3 and 5 years
at baseline and at 3 and 5 years
The impact of infection on morbidity and mortality in patients with IBD.
Time Frame: at baseline and at 3 and 5 years
at baseline and at 3 and 5 years
The type of infections in IBD patients grouped by systems and whether they are opportunistic or not.
Time Frame: at baseline and at 3 and 5 years
at baseline and at 3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Investigators

  • Principal Investigator: Yamile Zabana, Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INFEII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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