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

NCT02904590 | Completed DMC

• 1 other identifier: INFEII
• Study Type: observational
• Target: 1,204
• Locations: 1 country
• Sites: 24

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)

Conditions

Inflammatory Bowel Diseases

Keywords

IBD; Infection

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Change from baseline and at 3 and 5 years

Secondary Outcomes (3)

• The effect of duration and immunosuppressive potency in the development of infections

  at baseline and at 3 and 5 years

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

  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.

  at baseline and at 3 and 5 years

Study Arms (1)

IBD patients

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

Eligibility Criteria

• Age: 1 Year - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Incident cases of IBD registered on ENEIDA data base

You may qualify if:

• 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.

You may not qualify if:

• To be under any immunosuppressant therapy for another reason other than IBD at IBD diagnosis.
• No consent to participate.

Sponsors & Collaborators

• Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa: lead

Study Sites (24)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Althaia, xarxa assistencial universitaria de Manresa

Manresa, Barcelona, 08243, Spain

Location

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Moisès Broggi

Sant Joan Despí, Barcelona, 08970, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital de Galdakao

Galdakao, Bilbao, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital General de Tomelloso

Tomelloso, Ciudad REAL, 13700, Spain

Location

Hospital Universitario Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, 28703, Spain

Location

Complexo Hospital Universitario de Vigo

Vigo, Pontevedra, 36312, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitari Dr. Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital De La Princesa

Madrid, 28006, Spain

Location

Consorci hospitalari de Terrassa

Terrassa, 08227, Spain

Location

Hospital Clínic de València

Valencia, 46010, Spain

Location

Hospital Universitari La Fe

Valencia, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (16)

• 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.

  PMID: 23649185 BACKGROUND

• 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.

  PMID: 18294633 BACKGROUND

• 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.

  PMID: 16678077 BACKGROUND

• 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.

  PMID: 22890223 BACKGROUND

• 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.

  PMID: 20833661 BACKGROUND

• 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.

  PMID: 22683004 BACKGROUND

• 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.

  PMID: 21533108 BACKGROUND

• 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.

  PMID: 20521908 BACKGROUND

• 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.

  PMID: 19855253 BACKGROUND

• 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.

  PMID: 12517831 BACKGROUND

• 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.

  PMID: 23044675 BACKGROUND

• 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.

  PMID: 12525326 BACKGROUND

• 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.

  PMID: 15168804 BACKGROUND

• 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.

  PMID: 18832524 BACKGROUND

• 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.

  PMID: 20393175 BACKGROUND

• Jostins L, Ripke S, Weersma RK, Duerr RH, McGovern DP, Hui KY, Lee JC, Schumm LP, Sharma Y, Anderson CA, Essers J, Mitrovic M, Ning K, Cleynen I, Theatre E, Spain SL, Raychaudhuri S, Goyette P, Wei Z, Abraham C, Achkar JP, Ahmad T, Amininejad L, Ananthakrishnan AN, Andersen V, Andrews JM, Baidoo L, Balschun T, Bampton PA, Bitton A, Boucher G, Brand S, Buning C, Cohain A, Cichon S, D'Amato M, De Jong D, Devaney KL, Dubinsky M, Edwards C, Ellinghaus D, Ferguson LR, Franchimont D, Fransen K, Gearry R, Georges M, Gieger C, Glas J, Haritunians T, Hart A, Hawkey C, Hedl M, Hu X, Karlsen TH, Kupcinskas L, Kugathasan S, Latiano A, Laukens D, Lawrance IC, Lees CW, Louis E, Mahy G, Mansfield J, Morgan AR, Mowat C, Newman W, Palmieri O, Ponsioen CY, Potocnik U, Prescott NJ, Regueiro M, Rotter JI, Russell RK, Sanderson JD, Sans M, Satsangi J, Schreiber S, Simms LA, Sventoraityte J, Targan SR, Taylor KD, Tremelling M, Verspaget HW, De Vos M, Wijmenga C, Wilson DC, Winkelmann J, Xavier RJ, Zeissig S, Zhang B, Zhang CK, Zhao H; International IBD Genetics Consortium (IIBDGC); Silverberg MS, Annese V, Hakonarson H, Brant SR, Radford-Smith G, Mathew CG, Rioux JD, Schadt EE, Daly MJ, Franke A, Parkes M, Vermeire S, Barrett JC, Cho JH. Host-microbe interactions have shaped the genetic architecture of inflammatory bowel disease. Nature. 2012 Nov 1;491(7422):119-24. doi: 10.1038/nature11582.

  PMID: 23128233 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood sample of 10 cc

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Infections

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Yamile Zabana

  Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 19, 2016
• Study Start: October 1, 2016
• Primary Completion: July 1, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (24)