ANtibiotic TReatment OPtimisation – randomised controlled trial of Clostridioides difficile infection therapy (ANTROP-I)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fakultni Nemocnice Bulovka

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

25 Sep 2025 → ongoing

Decision date (initial)

2025-02-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Fakultní nemocnice Bulovka · Agentura pro zdravotnický výzkum České republiky

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

The primary objective is to verify the non-inferiority/superiority of 5-day treatment over the standard 10-day treatment of CDI with oral vancomycin.

Secondary objectives 4

1. Recovery rate in both treatment arms.
2. 16S rRNA genotyping of C. difficile strains isolated from the stool samples from participants to compare: a) The baseline ribotypes in both arms; b) The ribotypes at the initial and recurrent CDI episode in patients with rCDI occurring up to 60 days after the end of study treatment (D70).
3. Description of the safety in both treatment arms
4. EXPLORATORY: Collection of additional stool samples in the sub-study for future examination of changes in the microbiota

Conditions and MedDRA coding

Clostridioides difficile infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Adult age (≥ 18 years) at the time of enrolment
2. Presence of diarrhoea, i.e. ≥ 3 stools per day and a stool consistency that is not normal for the patient (mushy or watery stool)
3. 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])
4. Hospitalisation at the time of enrolment
5. Informed consent with participation in the clinical trial
6. Fertile men and women of childbearing potential: Consent with own sexual abstinence during the active treatment phase (10 days).
7. 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 8

1. Life expectancy of the patient is less than 3 months
2. Ongoing CDI episode is a recurrence (i.e. onset in ≤60 days from the last CDI episode)
3. Known allergy/hypersensitivity to vancomycin or excipients of the investigational medical products
4. Haemodynamic instability, critical condition or need for intensive care
5. Toxic megacolon or need for surgical intervention
6. 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.
7. 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
8. Pregnancy or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 4

1. 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.
2. 16S rRNA genotypes
3. The incidence of adverse events, their severity, duration, and relation to vancomycin.
4. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fakultni Nemocnice Bulovka

Sponsor organisation

Fakultni Nemocnice Bulovka

Address

Budinova 67/2, Liben Liben

City

Prague

Postcode

180 00

Country

Czechia

Scientific contact point

Organisation

Fakultni Nemocnice Bulovka

Contact name

Hynek Bartoš

Public contact point

Organisation

Fakultni Nemocnice Bulovka

Contact name

Hynek Bartoš

Third parties 3

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications