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

March 14, 2018 updated by: Maria J.G.T. Vehreschild, University of Cologne

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

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.

Study Overview

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)

Study Type

Observational

Enrollment (Anticipated)

541

Contacts and Locations

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

Study Contact

Study Locations

      • Cologne, Germany, 50937
      • Cologne, Germany, 51149
      • Hamburg, Germany, 20251
        • Recruiting
        • University Clinical Center Hamburg-Eppendorf
        • Contact:
    • Bavaria
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
    • Thuringia
      • Jena, Thuringia, Germany, 07740

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients with a CDI episode in German hospitals

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment of CDI
Treatment of CDI for hospitalized patients with Clostridium difficile associated diarrhea
Treatment (e.g. antibiotics, fecal microbiota transfer (FMT), probiotics) for patients with Clostridium difficile associated diarrhea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the cost of CDI index and recurrent episodes in German hospitals
Time Frame: 90 days
Analyse direct and indirect costs associated with CDI per day, hospitalization and year including description of incremental costs in hospitalized patients.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of health-related quality of life (HRQL)
Time Frame: 90 days
Assessment of quality of life of patients with an CDI episode using a QoL questionnaire
90 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Maria Vehreschild, MD, University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany

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.

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)

August 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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