A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

A Phase II, Randomized, Double-Blind, Active-Controlled Clinical Study to Investigate the Efficacy and Safety of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02092935

Enrollment

100

Registered

2014-03-20

Start date

2014-04-30

Completion date

2015-10-31

Last updated

2016-10-20

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

Conditions

Clostridium Difficile Infection

Keywords

CDAD, Clostridium Difficile

Brief summary

The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).

Interventions

DRUGSMT19969

DRUGVancomycin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Informed consent * Clinical diagnosis of CDAD plus laboratory diagnostic test * No more than 24 hrs antimicrobial treatment for current CDAD episode * No more than 3 episodes of CDAD in prior 12 months * No previous episode of CDAD within 30 days of study enrollment * Female subjects of childbearing potential must use adequate contraception

Exclusion criteria

* Life-threatening or fulminant colitis * Concurrent use of antibiotics or any other treatments for CDAD * History of inflammatory bowel disease (ulcerative colitis, Crohn's disease) * Participation in other Clinical research studies within one month of screening

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the clinical outcome by assessment of sustained clinical response	30 days post End of Therapy	Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy

Secondary

Measure	Time frame	Description
Plasma and faecal concentrations of SMT19969	40 Days	Using laboratory analysis
To assess the safety and tolerability of SMT19969 compared with vancomycin	40 days	Assessment of the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported within the study

Other

Measure	Time frame	Description
To assess the qualitative and quantitative effect of SMT19969 and Vancomycin on the bowel flora of subjects	40 days	Using microbiology, sequencing, metagenomic and bioinformatics techniques.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026