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

Clostridium Difficile Infection Clinical Trial

— IBIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03141775
• Other study ID #: IBIS
• Status: Recruiting
• Phase: N/A
• First received: May 3, 2017
• Last updated: March 14, 2018
• Start date: August 1, 2017
• Est. completion date: June 2019

Study information

• Verified date: March 2018
• Source: University of Cologne
• Contact: Maria Vehreschild, MD
• Phone: +49 221 478
• Email: maria.vehreschild[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 541
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Difficile Diarrhea
• Clostridium Difficile Infection
• Communicable Diseases
• Diarrhea
• Infection

Intervention

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

Locations

Country	Name	City	State
Germany	Hospital Porz am Rhein	Cologne
Germany	University Hospital of Cologne	Cologne
Germany	University Clinical Center Hamburg-Eppendorf	Hamburg
Germany	University Hospital Jena	Jena	Thuringia
Germany	University Hospital Magdeburg	Magdeburg	Saxony-Anhalt
Germany	Städtisches Klinikum München	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

Vehreschild MJ, Weitershagen D, Biehl LM, Tacke D, Waldschmidt D, Töx 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the cost of CDI index and recurrent episodes in German hospitals	Analyse direct and indirect costs associated with CDI per day, hospitalization and year including description of incremental costs in hospitalized patients.	90 days
Secondary	Assessment of health-related quality of life (HRQL)	Assessment of quality of life of patients with an CDI episode using a QoL questionnaire	90 days