Use of Bezlotoxumab for the Prevention of Clostridium difficile infections within the German health care system - an observational post-authorization study

Use of Bezlotoxumab for the Prevention of Clostridium difficile infections within the German health care system - an observational post-authorization study - BODEGA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030583

Enrollment

100

Registered

2022-10-31

Start date

2020-03-30

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A04.7

Interventions

Group 1: The study population consists of hospitalised or outpatients with an index episode of CDI receiving bezlotoxumab for the prevention of CDI recurrence. CDI recurrence is defined as recurrence

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Written informed consent - Treatment of a C. diff. infection with bezlotoxumab or intended treatment with bezlotoxumab for the prevention of C. diff. infection - Minimum age 18 years

Exclusion criteria

Exclusion criteria: Patients 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

Design outcomes

Primary

Measure	Time frame
To assess clinical efficacy of bezlotoxumab, defined as lack of recurrence at day 90	—

Secondary

Measure	Time frame
1. To understand the logistics and conditions that lead to successful administration of bezlotoxumab 2. To assess standard of care treatment utilization combined with bezlotoxumab	—

Countries

Germany

Contacts

Public ContactKatharina Giesbrecht,

Universitätsklinikum Frankfurt, Zentrum der Inneren Medizin, Klinik II, Infektiologie,

katharina.giesbrecht@kgu.de+49 (0)69 6301-5452,

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026