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

Clostridium Difficile Infection Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

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

• NCT number: NCT03141775
• Study type: Observational
• Source: University of Cologne
• Contact: Maria Vehreschild, MD
• Phone: +49 221 478
• Email: maria.vehreschild@uk-koeln.de
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Completion date: June 2019