- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03141775
Incidence and Economic Burden of Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS) (IBIS)
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
Status
Intervention / Treatment
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:
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.
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Maria Vehreschild, MD
- Phone Number: 88794 +49 221 478
- Email: maria.vehreschild@uk-koeln.de
Study Locations
-
-
-
Cologne, Germany, 50937
- Recruiting
- University Hospital of Cologne
-
Contact:
- Maria Vehreschild, MD
- Phone Number: +49 221 478 88794
- Email: maria.vehreschild@uk-koeln.de
-
Cologne, Germany, 51149
- Not yet recruiting
- Hospital Porz am Rhein
-
Contact:
- Wolfgang Holtmeier, Prof
- Phone Number: 1326 +492203/566
- Email: W.Holtmeier@khporz.de
-
Contact:
- Stefan Pützfeld, MD
- Email: s.puetzfeld@khporz.de
-
Hamburg, Germany, 20251
- Recruiting
- University Clinical Center Hamburg-Eppendorf
-
Contact:
- Stefan Schmiedel, MD
- Email: s.schmiedel@uke.de
-
-
Bavaria
-
Munich, Bavaria, Germany, 81737
- Recruiting
- Städtisches Klinikum München
-
Contact:
- Meinolf Karthaus, Prof
- Phone Number: 5245 +49 89 6210
- Email: meinolf.karthaus@klinikum-muenchen.de
-
-
Saxony-Anhalt
-
Magdeburg, Saxony-Anhalt, Germany, 39120
- Recruiting
- University Hospital Magdeburg
-
Contact:
- Enrico Schalk, MD
- Email: Enrico.Schalk@med.ovgu.de
-
-
Thuringia
-
Jena, Thuringia, Germany, 07740
- Recruiting
- University Hospital Jena
-
Contact:
- Philipp Reuken, MD
- Phone Number: 24504 +49 3641 93
- Email: philipp.reuken@med.uni-jena.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Maria Vehreschild, MD, University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBIS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Clostridium Difficile Infection
-
Vedanta Biosciences, Inc.CompletedClostridium Difficile Infection | Clostridium Difficile Infection Recurrence | Clostridium Difficile | CDI | Clostridioides Difficile Infection | Clostridioides Difficile | Clostridioides Difficile Infection RecurrenceUnited States, Canada
-
Vedanta Biosciences, Inc.Not yet recruitingClostridium Difficile Infection Recurrence | Recurrent Clostridium Difficile Infection | Clostridium Difficile | Diarrhea Infectious | CDI | Clostridium Difficile Infections | Clostridioides Difficile Infection | C.Difficile Diarrhea | Clostridioides Difficile Infection Recurrence | C. Diff Infection
-
University of PennsylvaniaTerminatedSevere Clostridium Difficile Infection | Severe-Complicated/Fulminant Clostridium Difficile InfectionUnited States
-
Mikrobiomik Healthcare Company S.L.CompletedRecurrent Clostridium Difficile Infection | Primary Clostridium Difficile InfectionSpain
-
University Health Network, TorontoTerminatedRecurrent Clostridium Difficile Infection | Laboratory Confirmed Clostridium Difficile InfectionCanada
-
University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)Enrolling by invitationClostridium Difficile Infection | Clostridium Difficile | C Difficile ColitisUnited States
-
University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences Institute; North Carolina...CompletedClostridium DifficileUnited States
-
MJM BontenUniversiteit Antwerpen; Universitätsklinikum Köln; Da VolterraCompletedClostridium DifficileGermany, Spain, France, Greece, Netherlands, Romania
-
Astellas Pharma Europe Ltd.Cubist Pharmaceuticals LLCTerminatedClostridium DifficileSpain, France, Germany, Greece, Denmark, Austria, Poland
-
Chinese University of Hong KongUnknownClostridium Difficile Infection | Clostridium DifficileHong Kong
Clinical Trials on Treatment of CDI
-
King Chulalongkorn Memorial HospitalCompletedClostridium Difficile Infection
-
University of California, IrvineCompletedCerebral IschemiaUnited States
-
University of Illinois at ChicagoMerck Sharp & Dohme LLCCompletedClostridium Difficile Infection | Clostridium Difficile Infection RecurrenceUnited States
-
University of California, IrvineTerminatedCoronary Artery Disease | Heart Valve DiseaseUnited States
-
Cocrystal Pharma, Inc.Completed
-
Otsuka Pharmaceutical Co., Ltd.CompletedClostridium Difficile InfectionJapan
-
Humanity & Health Medical Group LimitedWithdrawnHCV InfectionHong Kong
-
Neuromed IRCCSUnknownEpilepsy, Rolandic | BECTSItaly
-
NorthShore University HealthSystemCompletedClostridium Difficile InfectionUnited States
-
Rambam Health Care CampusFondazione Policlinico Universitario Agostino Gemelli IRCCS; Imperial College... and other collaboratorsNot yet recruitingClostridioides Difficile InfectionIsrael, Canada, Hungary, Italy, Lithuania, United Kingdom