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Completed

NCT Number: NCT02784002

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

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

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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Liberec, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ridinilazole

Drug

Other names: SMT19969

Fidaxomicin

Drug

Primary outcomes

  1. Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability

    Time frame: 30 days post End of Therapy

Secondary outcomes

  1. To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969

    Time frame: 12 days

  2. To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques

    Time frame: 40 days

  3. Measure clinical cure rates at the Test of Cure (TOC) visit

    Time frame: 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.

  4. Measure sustained clinical response (SCR) rates

    Time frame: 40 days

    SCR is defined as clinical cure at TOC and no recurrence of CDI within 30 days post end of treatment (EOT).

Sponsors and collaborators

Lead sponsor

Summit Therapeutics

Industry

Registry information

Official study title

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)

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 26, 2016
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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