Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (Ri-CoDIFy 1)

March 1, 2023 updated by: Summit Therapeutics

A Phase 3, Randomized, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Ridinilazole (200 mg, Bid) for 10 Days With Vancomycin (125 mg, Qid) for 10 Days in the Treatment of Clostridium Difficile Infection (CDI)

Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects treated with vancomycin.

A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted.

The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.

Ridinilazole plasma concentration will be assessed in a subset of patients.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

759

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, BI900AVG
        • Instituto Medico Platense
      • Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1221ADC
        • Hospital Ramos Mejía
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado Centro Medico Cordoba
      • Salta, Argentina, CP4400
        • Instituto Médico Alas
    • Buenos Aires
      • El Talar, Buenos Aires, Argentina, 1608
        • Centro Médico Talar
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Center
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
      • Sao Paulo, Brazil, 01327-001
        • Hospital Alemao Oswaldo Cruz
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150221
        • Santa Casa de Misericordia de Belo Horizonte
      • Belo Horizonte, Minas Gerais, Brazil, 30110-936
        • Unidade de Pesquisa - NCS - Hospital Felício Rocho
      • Belo Horizonte, Minas Gerais, Brazil, 30140-030
        • Hospital Vera Cruz
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020090
        • Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital das Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90160-092
        • Hospital Ernesto Dornelles
    • Sao Paulo
      • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
      • Blagoevgrad, Bulgaria, 2700
        • "MHAT - Blagoevgrad, EOOD Department of Gastroenterology"
      • Sliven, Bulgaria, 8800
        • DCC1-Sliven Ltd.
      • Sofia, Bulgaria, 1431
        • DCC Alexandrovska
      • Sofia, Bulgaria, 1612
        • Medical center - Izgrev
    • Kyustendil
      • Dupnitsa, Kyustendil, Bulgaria, 2600
        • MHAT "Sv.Ivan Rilski-2003"OOD
      • Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Québec- ULaval
      • Quebec, Canada, J7Z 5T3
        • Recherche Médicale St-Jérôme Inc
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre, South Tower
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Moncton Hospital/Horizon Health Network
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health
    • Quebec
      • Montréal, Quebec, Canada, H2X 1R9
        • Centre Hospitalier de l'Université de Montréal
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Centre Intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
      • Athens, Greece, 10676
        • General Hospital of Athens ''Evangelismos'
      • Athens, Greece, 115-28
        • General Hospital of Athens ''Alexandra''
      • Athens, Greece, 11527
        • "Pathophysiology Department Athens University Medical School"
      • Athens, Greece, 12462
        • " ATTIKON University Hospital"
      • Athens, Greece, 15121 Marousi
        • "'Hygeia'' Hospital 2nd Department of Medicine and Infectious Diseases"
      • Heraklion, Greece, 71110
        • University Hospital of Heraklion
      • Patras, Greece, 265 04
        • University Hospital of Patras
      • Piraeus, Greece, 185 -36
        • ''Tzaneio'' General Hospital of Piraeus
      • Balassagyarmat, Hungary, 2660
        • Dr. Kenessey Albert Kórház Rendelőintézet, Tüdőgyógyászati Aktív Osztály
      • Budapest, Hungary, H-1097
        • "Dél-Pesti Centrumkórház-OHII Szent László Kórház Infektológiai Osztály "
      • Budapest, Hungary, H-1122
        • Országos Korányi Pulmonológiai Intézet, Központi Intenzív osztály
      • Békéscsaba, Hungary, 5600
        • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház IV. Belgyógyászat - 2. Gasztroenterológia
      • Miskolc, Hungary, 3529
        • CRU Hungary Kft BAZ Megyei Kórház és Egyetemi Oktatókórház, Szent Ferenc Tagkórház
      • Pécs, Hungary, H-7623
        • "Pécsi Tudományegyetem I. sz. Belgyógyászat i Klinika, Infektológiai tanszék"
      • Pécs, Hungary, H-7624
        • Pécsi Tudományegyetem Klinikai Központi Gyógyszertár
      • Szentes, Hungary, H-6600
        • Csongrad County Dr. Bugyi Istvan Hospital, Dept. Of Internal Medicine
      • Vác, Hungary, 2600
        • Javorszy Odon Hospital
    • Békés
      • Gyula, Békés, Hungary, 5700
        • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház, Infektológia-Hepatológia Osztály
    • Pest Megye
      • Kistarcsa, Pest Megye, Hungary, 2143
        • Pest Megyei Flór Ferenc Kórház, V. Belgyógyászat
      • Junggu, Korea, Republic of, 04551
        • Inje University Seoul Paik Hospital
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 05355
        • Kangdong Sacred Heart Hospital
      • Soeul, Korea, Republic of, 08307
        • Korea University Guro Hospital
      • Soeul, Korea, Republic of, 5505
        • Asan Medical Center
    • Gangwon-do
      • Chuncheon, Gangwon-do, Korea, Republic of, 24253
        • Hallym University Chuncheon Sacred Heart Hospital
    • Gangwondo
      • Ilsan-dong, Gangwondo, Korea, Republic of, 26426
        • WonJu Severance Christian Hospital
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
        • Korea University Ansan Hospital
      • Guri-Si, Gyeonggi-do, Korea, Republic of, 11923
        • Hanyang University Guri Hospital
    • Seoul
      • Ansan, Seoul, Korea, Republic of, 04763
        • Hanyang University Seoul Hospital
      • Anyang-si, Seoul, Korea, Republic of, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Daegu, Seoul, Korea, Republic of, 41944
        • Kyungpook National University Hospital
      • Daegu, Seoul, Korea, Republic of, 42415
        • Yeungnam University Medical Center
      • Irwon-dong, Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
    • Yeongnam
      • Daegu, Yeongnam, Korea, Republic of, 42601
        • Keimyung University Dongsan Hospital
    • Auckland
      • Takapuna, Auckland, New Zealand, 0740
        • Waitemata District Health Board WDHB North Shore Hospital
    • Taranki
      • New Plymouth, Taranki, New Zealand, 4310
        • Taranaki District Health Board TDHB - Taranaki Base Hospital
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Waikato District Health Board Waikato Hospital
      • Bochnia, Poland, 32-700
        • SP ZOZ w Bochni Szpital Powiatowy im. B. Marty Wieckiej
      • Bochnia, Poland, 32-700
        • Szpital Bocheński SP ZOZ w Bochni
      • Bydgoszcz, Poland, 85-030
        • Klinika Chorób Zakaźnych i Hepatologii Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza
      • Chorzów, Poland, 41-500
        • Szpital Specjalistyczny w Chorzowie
      • Katowice, Poland, 40-211
        • Szpital Zakonu Bonifratrow
      • Krakow, Poland, 30-539
        • Specjalistyczne Gabinety Sp z o.o.
      • Rzeszow, Poland, 35-302
        • Korczowski Bartosz Gabinet
      • Sopot, Poland, 81-756
        • Endoskopia Sp. z o.o.
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny MSWiA Klinika Chorób Wewnętrznych i Gastroenterologii
      • Warszawa, Poland, 02-507
        • Klinika Chorób Wewnętrznych i Gastroenterologii z Pododdziałem Leczenia Nieswoistych Chorób Zapalnych Jelit Centralny Szpital Kliniczny MSWiA
      • Wroclaw, Poland, 51-149
        • Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego we Wrocławiu; I Oddział Chorób Zakaźnych
    • Podkarpackie
      • Rzeszów, Podkarpackie, Poland, 35-302
        • Gabinet Lekarski Bartosz Korczowski
      • Bucuresti, Romania, 010825
        • SUUMC-Boli infectioase
      • Bucuresti, Romania, 030303
        • Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"
      • Bucuresti, Romania, 11025
        • S.C. Sana Monitoring Srl
      • Bucuresti, Romania, 30303
        • Spitalul Clinic de Boli Infectioase si Tropicale
      • Caracal, Romania, 235200
        • Spitalul Minicipal Caracal
      • Constanta, Romania, 900709
        • Spitalul Clinic de Boli Infectioase Constanta
      • Iasi, Romania, 700722
        • Spitalul Clinic de Boli Infectioase- Sfanta Parascheva
      • Iaşi, Romania, 700722
        • Spitalul Clinic de Boli Infectioase
      • Timișoara, Romania, 300723
        • Spitalul Clinic Judetean de Urgenta Timisoara
      • Moscow, Russian Federation, 115516
        • " State Budgetary Institution of Healthcare "City Clinical Hospital of n.a. V.M.Buyanova" "
      • Novosibirsk, Russian Federation, 630051
        • State budget healthcare institution of Novosibirsk region "City clinical hospital #2"
      • Barakaldo, Spain, 48903
        • Hospital Universitario Cruces
      • Barcelona, Spain, 8041
        • Hospital de La Santa Creu i Sant Pau
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofía. Hospital Provincial
      • Donostia, Spain, 20014
        • "Hospital Universtiario Donostia "
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Santander, Spain, 39008
        • "Hospital Universitario Marqués de Valdecilla "
      • Sevilla, Spain, 41014
        • Hospital Universitario de Balme
      • Tarragona, Spain, 43204
        • Hospital Universitari Sant Joan de Reus
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama - Birmingham
    • Arizona
      • Sun City, Arizona, United States, 85351
        • GI Alliance - Arizona Digestive Health - Sun City
    • California
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA
      • Mission Hills, California, United States, 91345
        • Facey Medical Foundation
      • Redding, California, United States, 96601
        • Paradigm Clinical Research Centers, Inc
      • Sacramento, California, United States, 95817
        • University of California Davis
    • Florida
      • Fort Pierce, Florida, United States, 34982
        • Midway Immunology and Research Center
      • Lighthouse Point, Florida, United States, 33064
        • Alliance Medical Research LLC
      • Miami, Florida, United States, 33165
        • Phoenix Medical Research LLC
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Research
      • Naples, Florida, United States, 31402
        • Gasteroenterology Group of Naples
      • Orlando, Florida, United States, 32819
        • HeuerMD Research Inc
      • Pembroke Pines, Florida, United States, 33026
        • Pines Care Research Center Inc.
      • Saint Petersburg, Florida, United States, 33713
        • Professional Health Care of Pinellas
      • Seminole, Florida, United States, 33777
        • Bardmoor GastroEnterology
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic P.A.
    • Georgia
      • Decatur, Georgia, United States, 30333
        • Infectious Disease Specialists of Atlanta
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group PLLC
    • Illinois
      • Glenview, Illinois, United States, 60026
        • GI Alliance - Illinois Gastro Group - Glenview
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Peoria, Illinois, United States, 61603
        • UnityPoint Health Peoria/Proctor
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608-1216
        • St. Vincent Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201-2020
        • Harper Hospital Department of Pharmacy Services
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving Hospital Department of Pharmacy Services
      • Flint, Michigan, United States, 48504-4730
        • Aa Mrc Llc
      • Royal Oak, Michigan, United States, 48073-6712
        • William Beaumont Hospital
      • Southfield, Michigan, United States, 48034
        • Revival Research Institute, LLC.
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group PLLC
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • AB Clinical Trials
    • New York
      • Bronx, New York, United States, 10468
        • James J. Peters VAMC
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital Weill Cornell
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • ECU Adult Specialty Care
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem
    • Ohio
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Monument Health Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404-3230
        • Chattanooga Research and Medicine CHARM
    • Texas
      • Arlington, Texas, United States, 76012
        • GI Alliance - Texas Digestive Disease Consultants - Arlington
      • Cedar Park, Texas, United States, 78613
        • GI Alliance - Texas Digestive Disease Consultants - Cedar Park
      • Conroe, Texas, United States, 77304
        • DM Clinical Research (Conroe Regional Hospital)
      • Lampasas, Texas, United States, 76550
        • FMC Science
      • San Marcos, Texas, United States, 78666
        • GI Alliance - Texas Digestive Disease Consultants - San Marcos
      • Webster, Texas, United States, 77598
        • GI Alliance - Texas Digestive Disease Consultants - Webster
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Infectious Diseases Associates of Central VA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients are eligible to be included in the study only if all the following criteria apply:

  1. Patient must be at least 18 years of age, at the time of signing the informed consent.
  2. Have signs and symptoms of CDI including diarrhea such that in the Investigator's opinion, CDI antimicrobial therapy is required. Diarrhea is defined as a change in bowel habits, with ≥3 unformed bowel movements (UBMs) (5, 6 or 7 on the Bristol Stool Chart) in the 24 h prior to randomization.
  3. Have the presence of either toxin A and/or B of C. difficile in the stool determined by a positive free toxin test (using a Sponsor agreed test). The stool sample must be current (produced within 72 hours prior to randomization).
  4. Male or Female

    Male patients:

    • A male patient must agree to use contraception as detailed in Section 10.4 of this protocol during the treatment period and for at least 30 days after the last dose of study treatment and refrain from donating sperm during this period.

    Female patients:

    • A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i. Not a woman of childbearing potential (WOCBP) OR ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.

  5. Has provided documented signed informed consent and any authorizations required by local law (e.g. Protected Health Information [PHI]). If unable to read, understand and sign the informed consent form a legally authorized representative (LAR) may provide consent on the patient's behalf if permitted by the Institutional Review Board (IRB)/Ethics Committee (EC).

Exclusion Criteria

Patients are excluded from the study if any of the following criteria apply:

  1. Have had more than one prior episode of CDI in the previous 3 months or more than 3 episodes in the past 12 months prior to randomization.
  2. Have a history of chronic diarrheal disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  3. Have had a positive diagnostic test for other GI pathogens, considered to be clinically relevant, within 2 weeks of randomization.
  4. Have had major gastrointestinal (GI) surgery (e.g. significant bowel resection) within 3 months of randomization (this does not include appendectomy). The presence of a colostomy or ileostomy or likely requirement of an ostomy during the study.
  5. Have life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon.
  6. History of bone marrow or hematopoietic stem cell transplant at any time or a known current history of a severely compromised/suppressed immune system that, in the opinion of the Investigator, would make the patient unsuitable for the study.
  7. Have had more than the equivalent of 24 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization. (i.e. more than four doses of oral vancomycin, two doses of fidaxomicin or three doses of metronidazole).
  8. Prior or current use of anti-toxin antibodies including bezlotoxumab within the past 6 months prior to randomization.
  9. Are unable to discontinue products used affecting disease progression at randomization.
  10. Has been involved in a clinical trial and received an investigational medicinal product for indications other than CDI within 1 month or five half-lives (whichever is longer) or within 3 months if the investigational medical product was for CDI.
  11. Have received an investigational vaccine against C. difficile.
  12. Patients that the Investigator feels are inappropriate for the study this would include those;

    1. with any other condition that, in the Investigator's judgment, would make the patient unsuitable for inclusion in the study.
    2. who, in the opinion of the Investigator, are not likely to complete the study for whatever reason, e.g. short life expectancy.
    3. with known hypersensitivity or intolerance to ridinilazole, vancomycin, and/or their excipients
    4. who are unwilling or unable to comply with protocol requirements, e.g. complete the full course of study treatment per schedule, attend study visits, report diarrhea/suspected recurrence, provide stool samples, ingest capsules/tablets or blood draws.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ridinilazole
ridinilazole 200mg bid
ridinilazole (200 mg bid)
Other Names:
  • 2,2'-di(pyridin-4-yl)-1H,1'H-5,5'-bi(benzimidazole), 2,2'-bis(4-pyridyl)-3H,3'H-5,5'-bibenzimidazole, 2-pyridin-4-yl-6-(2-pyridin-4-yl-3H-benzimidaz
Active Comparator: vancomycin
vancomycin 125 mg qid
vancomycin (125 mg qid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Sustained Clinical Response (SCR) Defined as Clinical Response and no Recurrence of CDI Through 30 Days Post End of Treatment (EOT).
Time Frame: Day 40
This primary outcome measures the number of participants with Sustained Clinical Response (SCR). SCR is defined as Clinical Response and no recurrence of CDI through 30 days post End of Treatment (EOT). At D40, D70 and D100 the Investigator or medically qualified designee will determine if the patient has a sustained clinical response or experienced RECURRENCE since the previous assessment. The Investigator will assess cure/failure and recurrence based on available information which includes, but is not limited to, improvement from baseline in the number of UBMs, signs & symptoms of CDI, and the requirement for CDI medication. The Investigator should assess cure/failure in a way that best reflects the Investigator's standard clinical practice.
Day 40

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Cure
Time Frame: Day 12
defined as the resolution of diarrhea (<3 UBMs in the 1-day period immediately prior to EOT, that is maintained for 2 days after EOT).
Day 12
Clinical Response
Time Frame: Day 12

defined as

  • less than 3 unformed bowel movements (UBMs) for consecutive days and maintained through EOT without further CDI treatment at EOT + 2 days, or
  • the investigator's assessment that the subject no longer needs specific CDI antimicrobial treatment after completion of the course of study medication.
Day 12
Sustained Clinical Response Over 60 Days
Time Frame: Day 70
defined as Clinical Response and no recurrence of CDI through 60 days post EOT
Day 70
Sustained Clinical Response Over 90 Days
Time Frame: Day 100
defined as Clinical Response and no recurrence of CDI through 90 days post EOT
Day 100
Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT.
Time Frame: Day 10
This secondary outcome measures the relative abundance of the 3 main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) from Baseline to EOT.
Day 10
Percentage of Change of α-diversity (Shannon Index) of the Microbiota in Stool Samples From Baseline to EOT.
Time Frame: Day 10
This secondary outcome measures the percentage of change of α-diversity (Shannon Index) of the microbiota in stool samples from baseline to EOT. Shannon index is a weighted statistic measuring both species richness and evenness. The Shannon Index is calculated by taking the relative abundance of each species and sums the relative abundance times the natural log of the relative abundance for each species. The value is converted into a positive value by times minus one. A higher Shannon Index means higher diversity
Day 10
Measure of β-diversity of the Gut Microbiota Between Baseline and EOT Stool Samples (Bray-Curtis Index/Dissimilarity).
Time Frame: Day 10
This secondary outcome measures the β-diversity of the gut microbiota in stool samples from baseline to EOT. Bray-Curtis index/dissimilarity measures how different two samples are in the microbiome composition. The Bray-Curtis dissimilarity is graded between 0 and 1, where 0 means the two samples have the same composition (that is they share all the species and every species has the same abundance), and 1 means the two samples do not share any species.
Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Lori Styles, MD, Summit Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2019

Primary Completion (Actual)

November 17, 2021

Study Completion (Actual)

November 17, 2021

Study Registration Dates

First Submitted

June 11, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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