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

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ClinicalTrials.gov Identifier: NCT03141775
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Maria J.G.T. Vehreschild, University of Cologne

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.


Condition or disease Intervention/treatment
Clostridium Difficile Infection Clostridium Difficile Diarrhea Other: Treatment of CDI

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)

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Study Type : Observational
Estimated Enrollment : 541 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Incidence and Economic Burden of Community and Hospital- Acquired Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS)
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients with a CDI episode in German hospitals
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141775


Contacts
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Contact: Maria Vehreschild, MD +49 221 478 ext 88794 maria.vehreschild@uk-koeln.de

Locations
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Germany
Städtisches Klinikum München Recruiting
Munich, Bavaria, Germany, 81737
Contact: Meinolf Karthaus, Prof    +49 89 6210 ext 5245    meinolf.karthaus@klinikum-muenchen.de   
University Hospital Magdeburg Recruiting
Magdeburg, Saxony-Anhalt, Germany, 39120
Contact: Enrico Schalk, MD       Enrico.Schalk@med.ovgu.de   
University Hospital Jena Recruiting
Jena, Thuringia, Germany, 07740
Contact: Philipp Reuken, MD    +49 3641 93 ext 24504    philipp.reuken@med.uni-jena.de   
University Hospital of Cologne Recruiting
Cologne, Germany, 50937
Contact: Maria Vehreschild, MD    +49 221 478 88794    maria.vehreschild@uk-koeln.de   
Hospital Porz am Rhein Not yet recruiting
Cologne, Germany, 51149
Contact: Wolfgang Holtmeier, Prof    +492203/566 ext 1326    W.Holtmeier@khporz.de   
Contact: Stefan Pützfeld, MD       s.puetzfeld@khporz.de   
University Clinical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20251
Contact: Stefan Schmiedel, MD       s.schmiedel@uke.de   
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Maria Vehreschild, MD University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany

Publications:
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Responsible Party: Maria J.G.T. Vehreschild, PD MD, University of Cologne
ClinicalTrials.gov Identifier: NCT03141775     History of Changes
Other Study ID Numbers: IBIS
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Maria J.G.T. Vehreschild, University of Cologne:
Clostridium difficile associated diarrhea (CDAD)

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Diarrhea
Clostridium Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections