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Inflammatory Bowel DiseasesINFEIINCT02904590

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

An observational study of Inflammatory Bowel Diseases, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 24 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 1 year to 100 years
Conditions the study is for
Inflammatory Bowel Diseases
How many people
1,204 participants
Where
24 sitesSpain
Study dates
Oct 2016to Jul 2020
How long will I take part?
5 Years
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 1 year to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Incident cases of IBD registered on ENEIDA data base

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Spain24 sites

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Reina Sofía

    Córdoba, 14004

  • Hospital Universitario Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital de Galdakao

    Galdakao, Bilbao

  • Hospital Universitari Dr. Josep Trueta

    Girona, 17007

  • Hospital General de Granollers

    Granollers, Barcelona, 08402

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital De La Princesa

    Madrid, 28006

  • Althaia, xarxa assistencial universitaria de Manresa

    Manresa, Barcelona, 08243

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias

  • Corporació Sanitària Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28703

  • Hospital Moisès Broggi

    Sant Joan Despí, Barcelona, 08970

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Consorci hospitalari de Terrassa

    Terrassa, 08227

  • Hospital General de Tomelloso

    Tomelloso, Ciudad REAL, 13700

  • Hospital Clínic de València

    Valencia, 46010

  • Hospital Universitari La Fe

    Valencia

  • Complexo Hospital Universitario de Vigo

    Vigo, Pontevedra, 36312

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

About this study

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

Read the 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%.

Keywords
IBD, Infection
Medical subject headings
Inflammatory Bowel Diseases, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02904590
Study groupRoleWhat they receive
IBD patientsIncidental patients with IBD controlled (including Crohn's disease, Ulcerative colitis and unclassified colitis)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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

    Measured: Change from baseline incidence and type of infection at 3 and 5 years

  2. 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.

    Measured: Change from baseline and at 3 and 5 years

Secondary outcomes (3)

  1. The effect of duration and immunosuppressive potency in the development of infections

    Measured: at baseline and at 3 and 5 years

  2. The impact of infection on morbidity and mortality in patients with IBD.

    Measured: at baseline and at 3 and 5 years

  3. The type of infections in IBD patients grouped by systems and whether they are opportunistic or not.

    Measured: at baseline and at 3 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionJul 2020

Resources

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
1,204 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02904590
Sponsor's protocol ID
INFEII
Acronym
INFEII
Status last verified
Jul 2020
First submitted
26 Aug 2016
Last updated
23 Jul 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Ford AC, Peyrin-Biroulet L. Opportunistic infections with anti-tumor necrosis factor-alpha therapy in inflammatory bowel disease: meta-analysis of randomized controlled trials. Am J Gastroenterol. 2013 Aug;108(8):1268-76. doi: 10.1038/ajg.2013.138. Epub 2013 May 7.

    PubMed 23649185

  • Toruner M, Loftus EV Jr, Harmsen WS, Zinsmeister AR, Orenstein R, Sandborn WJ, Colombel JF, Egan LJ. Risk factors for opportunistic infections in patients with inflammatory bowel disease. Gastroenterology. 2008 Apr;134(4):929-36. doi: 10.1053/j.gastro.2008.01.012. Epub 2008 Jan 11.

    PubMed 18294633

  • Lichtenstein GR, Feagan BG, Cohen RD, Salzberg BA, Diamond RH, Chen DM, Pritchard ML, Sandborn WJ. Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. Clin Gastroenterol Hepatol. 2006 May;4(5):621-30. doi: 10.1016/j.cgh.2006.03.002.

    PubMed 16678077

  • Lichtenstein GR, Feagan BG, Cohen RD, Salzberg BA, Diamond RH, Price S, Langholff W, Londhe A, Sandborn WJ. Serious infection and mortality in patients with Crohn's disease: more than 5 years of follow-up in the TREAT registry. Am J Gastroenterol. 2012 Sep;107(9):1409-22. doi: 10.1038/ajg.2012.218. Epub 2012 Aug 14.

    PubMed 22890223

  • Beaugerie L, Gerbes AL. Liver dysfunction in patients with IBD under immunosuppressive treatment: do we need to fear? Gut. 2010 Oct;59(10):1310-1. doi: 10.1136/gut.2010.217331. No abstract available.

    PubMed 20833661

  • Papadopoulos AI, Ferwerda B, Antoniadou A, Sakka V, Galani L, Kavatha D, Panagopoulos P, Poulakou G, Protopapas K, van der Meer JW, Netea MG, Giamarellos-Bourboulis EJ. Association of Mal/TIRAP S180L variant polymorphism with decreased infection risk in patients with advanced HIV-1 infection. Cytokine. 2012 Oct;60(1):104-7. doi: 10.1016/j.cyto.2012.05.008. Epub 2012 Jun 8.

    PubMed 22683004

  • Radovanovic I, Mullick A, Gros P. Genetic control of susceptibility to infection with Candida albicans in mice. PLoS One. 2011 Apr 20;6(4):e18957. doi: 10.1371/journal.pone.0018957.

    PubMed 21533108

  • Papadopoulos AI, Ferwerda B, Antoniadou A, Sakka V, Galani L, Kavatha D, Panagopoulos P, Poulakou G, Kanellakopoulou K, van der Meer JW, Giamarellos-Bourboulis EJ, Netea MG. Association of toll-like receptor 4 Asp299Gly and Thr399Ile polymorphisms with increased infection risk in patients with advanced HIV-1 infection. Clin Infect Dis. 2010 Jul 15;51(2):242-7. doi: 10.1086/653607.

    PubMed 20521908

  • Pine SO, McElrath MJ, Bochud PY. Polymorphisms in toll-like receptor 4 and toll-like receptor 9 influence viral load in a seroincident cohort of HIV-1-infected individuals. AIDS. 2009 Nov 27;23(18):2387-95. doi: 10.1097/QAD.0b013e328330b489.

    PubMed 19855253

  • Jurevic RJ, Bai M, Chadwick RB, White TC, Dale BA. Single-nucleotide polymorphisms (SNPs) in human beta-defensin 1: high-throughput SNP assays and association with Candida carriage in type I diabetics and nondiabetic controls. J Clin Microbiol. 2003 Jan;41(1):90-6. doi: 10.1128/JCM.41.1.90-96.2003.

    PubMed 12517831

  • Connelly TM, Sehgal R, Berg AS, Hegarty JP, Deiling S, Stewart DB, Poritz LS, Koltun WA. Mutation in TAGAP is protective of anal sepsis in ileocolic Crohn's disease. Dis Colon Rectum. 2012 Nov;55(11):1145-52. doi: 10.1097/DCR.0b013e3182676931.

    PubMed 23044675

  • Obrador A, Lopez San Roman A, Munoz P, Fortun J, Gassull MA; Grupo Espanol de Trabajo de Enfermedad de Crohn y Colitis Ulcerosa (GETECCU). [Consensus guideline on tuberculosis and treatment of inflammatory bowel disease with infliximab. Spanish Working Group on Crohn Disease and Ulcerative Colitis]. Gastroenterol Hepatol. 2003 Jan;26(1):29-33. doi: 10.1016/s0210-5705(03)70338-0. No abstract available. Spanish.

    PubMed 12525326

  • Arts J, D'Haens G, Zeegers M, Van Assche G, Hiele M, D'Hoore A, Penninckx F, Vermeire S, Rutgeerts P. Long-term outcome of treatment with intravenous cyclosporin in patients with severe ulcerative colitis. Inflamm Bowel Dis. 2004 Mar;10(2):73-8. doi: 10.1097/00054725-200403000-00002.

    PubMed 15168804

  • Fidder H, Schnitzler F, Ferrante M, Noman M, Katsanos K, Segaert S, Henckaerts L, Van Assche G, Vermeire S, Rutgeerts P. Long-term safety of infliximab for the treatment of inflammatory bowel disease: a single-centre cohort study. Gut. 2009 Apr;58(4):501-8. doi: 10.1136/gut.2008.163642. Epub 2008 Oct 2.

    PubMed 18832524

  • Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.

    PubMed 20393175

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 24 sites in Spain.

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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?

On the ClinicalTrials.gov record for NCT02904590, which also lists 16 linked publications.

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 23 Jul 2020.

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