Clostridium Difficile InfectionIBISNCT03141775
Incidence and Economic Burden of Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS)
An observational study of Clostridium Difficile Infection and Clostridium Difficile Diarrhea, run by University of Cologne at 6 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection, Clostridium Difficile Diarrhea
- What is being tested?
- Treatment of CDI
- How many people
- 541 participants
- Where
- 6 sitesGermany
- Study dates
- 1 Aug 2017to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with a CDI episode in German hospitals
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
University Hospital of Cologne
Cologne, 50937
Maria Vehreschild, MD, +49 221 478 88794, maria.vehreschild@uk-koeln.de
- Not yet recruiting
Hospital Porz am Rhein
Cologne, 51149
Wolfgang Holtmeier, Prof, +492203/566 ext. 1326, W.Holtmeier@khporz.de
Stefan Pützfeld, MD, s.puetzfeld@khporz.de
- Recruiting
University Clinical Center Hamburg-Eppendorf
Hamburg, 20251
Stefan Schmiedel, MD, s.schmiedel@uke.de
- Recruiting
University Hospital Jena
Jena, Thuringia, 07740
Philipp Reuken, MD, +49 3641 93 ext. 24504, philipp.reuken@med.uni-jena.de
- Recruiting
University Hospital Magdeburg
Magdeburg, Saxony-Anhalt, 39120
Enrico Schalk, MD, Enrico.Schalk@med.ovgu.de
- Recruiting
Städtisches Klinikum München
Munich, Bavaria, 81737
Meinolf Karthaus, Prof, +49 89 6210 ext. 5245, meinolf.karthaus@klinikum-muenchen.de
About this study
Official title: 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.
Read the 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)
- Being tested
- Treatment of CDI
- Keywords
- Clostridium difficile associated diarrhea (CDAD)
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of CDIOther
Treatment (e.g. antibiotics, fecal microbiota transfer (FMT), probiotics) for patients with Clostridium difficile associated diarrhea
| Study group | Role | What they receive |
|---|---|---|
| Treatment of CDI | Treatment of CDI for hospitalized patients with Clostridium difficile associated diarrhea Receives: Other: Treatment of CDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (1)
Assessment of health-related quality of life (HRQL)
Assessment of quality of life of patients with an CDI episode using a QoL questionnaire
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Aug 2017
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 541 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria J.G.T. Vehreschild, University of Cologne
- Investigators
- Maria Vehreschild, MD, Principal investigator, University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141775
- Sponsor's protocol ID
- IBIS
- Acronym
- IBIS
- Status last verified
- Mar 2018
- First submitted
- 3 May 2017
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24607558Bauer 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.
PubMed 21084111Hensgens 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.
PubMed 23300235
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Economic Burden of Community and Hospital- Acquired Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS)
- ClinicalTrials.gov ID
- NCT03141775
- Acronym / sponsor ID
- IBIS / IBIS
- Keywords
- Clostridium difficile associated diarrhea (CDAD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 541 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of CDI | – | Other: Treatment of CDITreatment of CDI for hospitalized patients with Clostridium difficile associated diarrhea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with a CDI episode in German hospitals
Key inclusion criteria (6 listed)
- Index episode of CDI based on
- Ongoing or new hospitalization at inclusion into the study.
- Written informed consent (IC) has been obtained from the study subject or a legal representative.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of CDITreatment (e.g. antibiotics, fecal microbiota transfer (FMT), probiotics) for patients with Clostridium difficile associated diarrhea | Other | Treatment of CDI |
Primary outcome
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.
1 secondary outcome
Assessment of health-related quality of life (HRQL)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Background: PubMed 24607558Vehreschild 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.
- Background: PubMed 21084111Bauer 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.
- Background: PubMed 23300235Hensgens 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Vehreschild, MD principal investigator
University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection and Clostridium Difficile Diarrhea, run by University of Cologne at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Vehreschild, MD (+49 221 478 ext. 88794, maria.vehreschild@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the cost of CDI index and recurrent episodes in German hospitals (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141775, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.