NCT03141775

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
541

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

May 3, 2017

Last Update Submit

March 14, 2018

Conditions

Clostridium Difficile InfectionClostridium Difficile Diarrhea

Keywords

Clostridium difficile associated diarrhea (CDAD)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assessment of health-related quality of life (HRQL)

    90 days

Study Arms (1)

Treatment of CDI

Treatment of CDI for hospitalized patients with Clostridium difficile associated diarrhea

Other: Treatment of CDI

Interventions

Treatment of CDIOTHER

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

Treatment of CDI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients with a CDI episode in German hospitals

You may qualify if:

  • 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
  • Written informed consent (IC) has been obtained from the study subject or a legal representative.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Städtisches Klinikum München

Munich, Bavaria, 81737, Germany

RECRUITING

University Hospital Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

University Hospital Jena

Jena, Thuringia, 07740, Germany

RECRUITING

University Hospital of Cologne

Cologne, 50937, Germany

RECRUITING

Hospital Porz am Rhein

Cologne, 51149, Germany

NOT YET RECRUITING

University Clinical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 24607558BACKGROUND

  • 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.

    PMID: 21084111BACKGROUND

  • 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.

    PMID: 23300235BACKGROUND

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Maria Vehreschild, MD

    University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Vehreschild, MD

CONTACT

+49 221 478maria.vehreschild@uk-koeln.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD MD

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 5, 2017

Study Start

August 1, 2017

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

March 15, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(6)