VANCOMYCIN HYDROCHLORIDE for Clostridioides difficile infection

Inclusion criteria

• {"criterion_text":"- Adult age (≥ 18 years) at the time of enrolment\n- Presence of diarrhoea, i.e. ≥ 3 stools per day and a stool consistency that is not normal for the patient (mushy or watery stool)\n- Conclusive laboratory confirmation of C. difficile infection from a stool sample (i.e. presence of C. difficile antigen [glutamate dehydrogenase, GDH] and toxin [type A/B])\n- Hospitalisation at the time of enrolment\n- Informed consent with participation in the clinical trial\n- Fertile men and women of childbearing potential: Consent with own sexual abstinence during the active treatment phase (10 days).\n- Only for the sub-study: Written informed consent with participation in the sub-study and willingness to provide and collect stool samples repeatedly in the following 6 months."}

Exclusion criteria

• {"criterion_text":"- Life expectancy of the patient is less than 3 months\n- Ongoing CDI episode is a recurrence (i.e. onset in ≤60 days from the last CDI episode)\n- Known allergy/hypersensitivity to vancomycin or excipients of the investigational medical products\n- Haemodynamic instability, critical condition or need for intensive care\n- Toxic megacolon or need for surgical intervention\n- The patient has started therapy for the current CDI episode with metronidazole, tigecycline, or fidaxomicin, or has already used more than 2 doses of vancomycin.\n- Participation in another interventional clinical trial in the last 30 days or in a period equal to 5 half-lives of the respective investigational drug in that clinical trial, whichever is longer\n- Pregnancy or breastfeeding"}

Primary endpoints

• {"endpoint_text":"- The non-inferiority/superiority will be assessed using the incidence of CDI recurrence during 60 days after the end of study treatment as the primary endpoint.","definition_or_measurement_approach":"Incidence of CDI recurrence occurring within 60 days after the end of study treatment (i.e. measure proportion of participants with recurrence during the 60-day post-treatment period)."}

Secondary endpoints

• {"endpoint_text":"- Recovery is defined as a sustained clinical improvement in the patient’s overall health status for ≥48 hours, including reduced stool frequency and/or normalisation of consistency, alongside stabilisation or improvement in disease severity parameters (e.g., clinical, laboratory, radiological) and no new severe symptoms. Partial improvements, such as a significant reduction in stool frequency, also reflect treatment efficacy and are perceived as treatment response.","definition_or_measurement_approach":"Recovery measured as sustained clinical improvement for ≥48 hours with reduced stool frequency and/or normalization of consistency and stabilization/improvement of disease severity parameters; partial improvements also counted as response."}
• {"endpoint_text":"- 16S rRNA genotypes","definition_or_measurement_approach":"Genotyping (16S rRNA) of C. difficile strains isolated from stool samples to compare baseline ribotypes between arms and ribotypes at initial vs recurrent episodes up to 60 days after end of treatment."}
• {"endpoint_text":"- The incidence of adverse events, their severity, duration, and relation to vancomycin.","definition_or_measurement_approach":"Collection and reporting of adverse events including incidence, severity, duration, and assessed relationship to vancomycin."}
• {"endpoint_text":"- EXPLORATORY: Additional stool samples from patients will be collected and stored for future research: a. α-diversity dynamics during the sub-study period b. α-diversity value at the end of treatment c. Identification of main trajectories of microbiota recovery during the sub-study period (species-level) d. Presence of multidrug-resistant bacteria by genetic examination.","definition_or_measurement_approach":"Exploratory analyses on stored stool samples including α-diversity dynamics and values, species-level microbiota recovery trajectories, and genetic detection of multidrug-resistant bacteria."}

Czechia

Earliest CTIS Part Ii Submission Date

23-10-2024

Latest Decision Or Authorization Date

12-02-2026

Processing Time Days

477

Number Of Sites

8

Number Of Participants

244

Primary sponsor

Full Name

Fakultni Nemocnice Bulovka

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia

Third parties

• {"country":"Czechia","full_name":"Fakultni Nemocnice V Motole","duties_or_roles":"code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Czechia","full_name":"Masarykova Univerzita","duties_or_roles":"codes 1,10,11,12,5,6,8","organisation_type":"Educational Institution"}
• {"country":"Czechia","full_name":"Institute For Clinical And Experimental Medicine","duties_or_roles":"code 4","organisation_type":"Hospital/Clinic/Other health care facility"}