Incidence and Economic Burden of Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS)

NCT ID: NCT03141775

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 541 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-06-30

Brief Summary

IBIS is a prospective, observational study, which aims to assess the cost of CDI per day, hospitalization and year including description of incremental costs in hospitalized patients, and recurrent episodes, in German hospitals. Exposure to CDI drugs will not be influenced and remains at the discretion of the treating physician.

In addition to treatment, Health-related quality of life (HRQL) will be analyzed using standardized questionnaires.

Detailed Description

Documentation of patient is performed by using the web-based survey platform www.ClinicalSurveys.net which was set up by researchers of the University Hospital of Cologne. This survey platform enables an optimal performance in epidemiological, observational, and interventional trials and is characterized by layered access security and frequent data backup. It has been used for numerous registry and cohort studies with approval of competent authorities and ethics boards.

The following two differences of data documentation are observed:

1. Retrospective data documentation:

Data of patients that are too sick to provide informed consent, (up to 30% of all patients enrolled) will be obtained retrospectively, at least 90 days after diagnosis and will be documented in an anonymized fashion. For these patients, documentation of HRQL will not be feasible.

2. Prospective data documentation:

Data of patients with an informed consent.

The following data items are retrospectively or prospectively documented into our database, depending on if a informed consent exists or not:

• Demography: age (yrs), gender (m/f), comorbidities (as categories)
• Charlson Comorbidity Index (CCI)
• Karnofsky Score (0-100%)
• APACHE Score for patients in ICU
• Number of hospitalizations in the past 12 months prior to the CDI index episode
• Type and duration of antibiotic treatment during the last 3 months
• Diagnostic measures (microbiological tests, imaging, endoscopy) leading to diagnosis of CDI
• Severe and/or complicated CDI (Severe: white blood cell count ≥15 × 10³/μL and/or an increase in creatinine ≥1.5 times the baseline level; complicated: at least 1 of the following: hypotension requiring vasopressors, ICU admission for a complication of CDI, ileus leading to installation of a nasogastric tube, toxic megacolon, colonic perforation, or colectomy)
• Bowel movements: frequency and consistence according to Bristol stool scale (see appendix 1)
• Treatment for CDI: substance, dosage, frequency, duration
• Other antibiotic treatment: substance, dosage, frequency, duration
• Diagnosis of CDI recurrence: time point, diagnostic measures
• Treatment of CDI recurrence: substance, dosage, frequency, duration
• Duration of hospitalization: overall, types (general, intermediate care, intensive care, bone marrow transplantation)
• Mechanical ventilation (y/n)
• Days with contact isolation
• Days in single room
• Adverse drug reactions
• Health-related quality of life (HRQL) as determined by Garey et al. J Clin Gastroenterol 2016 (for prospective analysis only)

Conditions

Clostridium Difficile Infection; Clostridium Difficile Diarrhea

Study Design

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

Study Groups

Treatment of CDI

Treatment of CDI for hospitalized patients with Clostridium difficile associated diarrhea

Treatment of CDI

Intervention Type: OTHER

Treatment (e.g. antibiotics, fecal microbiota transfer (FMT), probiotics) for patients with Clostridium difficile associated diarrhea

Interventions

Treatment of CDI

Treatment (e.g. antibiotics, fecal microbiota transfer (FMT), probiotics) for patients with Clostridium difficile associated diarrhea

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Index episode of CDI based on

• the presence of diarrhea (defined as ≥3 unformed bowel movements/24h) plus
• an enzyme immunoassay (EIA) detecting Glutamate dehydrogenase (GDH) or polymerase chain reaction (PCR) for toxin B test plus
• a positive EIA for toxin A and B
• Ongoing or new hospitalization at inclusion into the study.
• Written informed consent (IC) has been obtained from the study subject or a legal representative.

Exclusion Criteria

• Patient with any social or logistical condition which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted after discharge.
• CDI episode within the previous 84 days.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Maria J.G.T. Vehreschild

PD MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Vehreschild, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany

Locations

Städtisches Klinikum München

Munich, Bavaria, Germany

Site Status: RECRUITING

University Hospital Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Site Status: RECRUITING

University Hospital Jena

Jena, Thuringia, Germany

Site Status: RECRUITING

University Hospital of Cologne

Cologne, , Germany

Site Status: RECRUITING

Hospital Porz am Rhein

Cologne, , Germany

Site Status: NOT_YET_RECRUITING

University Clinical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Maria Vehreschild, MD

Role: CONTACT

maria.vehreschild@uk-koeln.de

+49 221 478 ext. 88794

Facility Contacts

Meinolf Karthaus, Prof

Role: primary

meinolf.karthaus@klinikum-muenchen.de

+49 89 6210 ext. 5245

Enrico Schalk, MD

Role: primary

Enrico.Schalk@med.ovgu.de

Philipp Reuken, MD

Role: primary

philipp.reuken@med.uni-jena.de

+49 3641 93 ext. 24504

Maria Vehreschild, MD

Role: primary

maria.vehreschild@uk-koeln.de

+49 221 478 88794

Wolfgang Holtmeier, Prof

Role: primary

W.Holtmeier@khporz.de

+492203/566 ext. 1326

Stefan Pützfeld, MD

Role: backup

s.puetzfeld@khporz.de

Stefan Schmiedel, MD

Role: primary

s.schmiedel@uke.de

References

Vehreschild MJ, Weitershagen D, Biehl LM, Tacke D, Waldschmidt D, Tox U, Wisplinghoff H, Von Bergwelt-Baildon M, Cornely OA, Vehreschild JJ. Clostridium difficile infection in patients with acute myelogenous leukemia and in patients undergoing allogeneic stem cell transplantation: epidemiology and risk factor analysis. Biol Blood Marrow Transplant. 2014 Jun;20(6):823-8. doi: 10.1016/j.bbmt.2014.02.022. Epub 2014 Mar 6.

Reference Type: BACKGROUND

PMID: 24607558 (View on PubMed)

Bauer MP, Notermans DW, van Benthem BH, Brazier JS, Wilcox MH, Rupnik M, Monnet DL, van Dissel JT, Kuijper EJ; ECDIS Study Group. Clostridium difficile infection in Europe: a hospital-based survey. Lancet. 2011 Jan 1;377(9759):63-73. doi: 10.1016/S0140-6736(10)61266-4.

Reference Type: BACKGROUND

PMID: 21084111 (View on PubMed)

Hensgens MP, Goorhuis A, Dekkers OM, van Benthem BH, Kuijper EJ. All-cause and disease-specific mortality in hospitalized patients with Clostridium difficile infection: a multicenter cohort study. Clin Infect Dis. 2013 Apr;56(8):1108-16. doi: 10.1093/cid/cis1209. Epub 2013 Jan 8.

Reference Type: BACKGROUND

PMID: 23300235 (View on PubMed)

Other Identifiers

IBIS

Identifier Type: -

Identifier Source: org_study_id