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Antibiotic

Ridinilazole for Clostridioides difficile Infection (Ri-CoDIFy 3 Trial)

Phase 3
Waitlist Available
Research Sponsored by Summit Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through study completion, an average of 100 days
Awards & highlights

Ri-CoDIFy 3 Trial Summary

This trial will study the safety of ridinilazole in adolescents and how it is metabolized in the body.

Eligible Conditions
  • Clostridioides difficile Infection

Ri-CoDIFy 3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through study completion, an average of 100 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through study completion, an average of 100 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and Severity of Treatment-emergant Adverse Events
Secondary outcome measures
Clinical cure at the assessment of cure (AOC) visit
Clinical response at the AOC visit
SCR based on clinical response - defined as clinical response with no recurrence assessed through 30 days post-EOT
+3 more
Other outcome measures
Medical resource utilization and health economics endpoints

Side effects data

From 2021 Phase 3 trial • 759 Patients • NCT03595553
6%
Diarrhoea
3%
Nausea
2%
Abdominal pain
2%
Anaemia
2%
Hypertension
2%
Hypokalaemia
2%
Pyrexia
1%
Anxiety
1%
Pneumonia
1%
Abdominal distension
1%
Asthenia
1%
Cough
1%
Fall
1%
COVID-19 pneumonia
1%
Abdominal pain upper
1%
Atrial fibrillation
1%
Dizziness
1%
Fatigue
1%
Flatulence
1%
Haematochezia
1%
Headache
1%
Hepatic enzyme increased
1%
Hydrothorax
1%
Hypoglycaemia
1%
Hypotension
1%
Insomnia
1%
Nasal congestion
1%
Pain
1%
Pruritus
1%
Urinary tract infection
1%
Vomiting
1%
Colitis
1%
Decreased appetite
1%
Dyspnoea
1%
Blood creatinine increased
1%
Blood potassium decreased
1%
Blood potassium increased
1%
Blood urea increased
1%
Dyspepsia
1%
Hypocalcaemia
1%
Constipation
1%
Iron deficiency anaemia
1%
Urinary tract candidiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
RIDINILAZOLE 200 MG
VANCOMYCIN 125 MG

Ri-CoDIFy 3 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RidinilazoleExperimental Treatment1 Intervention
Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.
Group II: VancomycinActive Control1 Intervention
Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ridinilazole
2014
Completed Phase 3
~790

Find a Location

Who is running the clinical trial?

Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,947 Total Patients Enrolled
Summit TherapeuticsLead Sponsor
9 Previous Clinical Trials
2,227 Total Patients Enrolled
Robert HindesStudy DirectorSummit Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
2021. "Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04802837.
~1 spots leftby May 2025
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