A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)

A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200mg BID) for 10 Days Compared With Fidaxomicin (200 mg BID) for 10 Days for the Treatment of Clostridium Difficile Infection (CDI)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02784002

Enrollment

Registered

2016-05-26

Start date

2014-12-31

Completion date

2016-08-31

Last updated

2017-10-12

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

Conditions

Clostridium Difficile Infection

Brief summary

The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).

Interventions

DRUGRidinilazole

DRUGFidaxomicin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Informed Consent * Clinical diagnosis of CDI plus laboratory diagnostic test * No more than 30 hours antimicrobial treatment for current CDI episode * Female subjects of childbearing potential must use adequate contraception

Exclusion criteria

* Life-threatening or fulminant CDI * Subjects with 2 or more episodes of CDI in the previous year * Females who are pregnant or breastfeeding * History of inflammatory bowel disease * Co-administration of potent P-glycoprotein inhibitors * Participation in other Clinical research studies within one month of screening * Subjects that the Investigator feels are inappropriate for the study

Design outcomes

Primary

Measure	Time frame
Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability	30 days post End of Therapy

Secondary

Measure	Time frame	Description
To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969	12 days	—
To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques	40 days	—
Measure clinical cure rates at the Test of Cure (TOC) visit	12 days	Investigator assessed clinical response at the TOC visit (on day 12) with clinical cure defined as the resolution of diarrhoea (≤ 3 Unformed Bowel Movements (UBMs) per day) while on treatment that is maintained until the TOC visit.
Measure sustained clinical response (SCR) rates	40 days	SCR is defined as clinical cure at TOC and no recurrence of CDI within 30 days post end of treatment (EOT).

Countries

Czechia, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026