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

Conditions

Clostridioides difficile infection

Brief summary

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.

Detailed description

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

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGrice starch

DRUGVANCOMYCIN HYDROCHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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., 16S rRNA genotypes, The incidence of adverse events, their severity, duration, and relation to vancomycin., 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.	—

Measure

Time frame

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

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Countries

Czechia

Outcome results

None listed