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

NCT ID: NCT02904590

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1204 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31

Brief Summary

The purpose of this study is to determine the incidence and risk factors related to Infection in patients with Inflammatory Bowel Disease (IBD)

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%.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IBD patients

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yamile Zabana

Role: PRINCIPAL_INVESTIGATOR

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Locations

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital General de Granollers

Granollers, Barcelona, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Althaia, xarxa assistencial universitaria de Manresa

Manresa, Barcelona, Spain

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Hospital Moisès Broggi

Sant Joan Despí, Barcelona, Spain

Hospital Mutua de Terrassa

Terrassa, Barcelona, Spain

Hospital de Galdakao

Galdakao, Bilbao, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital General de Tomelloso

Tomelloso, Ciudad REAL, Spain

Hospital Universitario Fuenlabrada

Fuenlabrada, Madrid, Spain

Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, Spain

Complexo Hospital Universitario de Vigo

Vigo, Pontevedra, Spain

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Reina Sofía

Córdoba, , Spain

Hospital Universitari Dr. Josep Trueta

Girona, , Spain

Hospital Universitari Arnau de Vilanova

Lleida, , Spain

Hospital De La Princesa

Madrid, , Spain

Consorci hospitalari de Terrassa

Terrassa, , Spain

Hospital Clínic de València

Valencia, , Spain

Hospital Universitari La Fe

Valencia, , Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, , Spain

Countries

Spain

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Other Identifiers

INFEII

Identifier Type: -

Identifier Source: org_study_id