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Clostridioides Difficile InfectionPhase 3Ri-CoDIFy 1NCT03595553

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

A Phase 3 study testing Ridinilazole and Vancomycin in people with Clostridioides Difficile Infection, run by Summit Therapeutics at 149 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clostridioides Difficile Infection
What is being tested?
Ridinilazole and Vancomycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
759 participants
Where
149 sitesin 14 countries
Study dates
28 Jan 2019to 17 Nov 2021
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are eligible to be included in the study only if all the following criteria apply:
  • Patient must be at least 18 years of age, at the time of signing the informed consent.
  • 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.
  • 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).
  • Male or Female
  • Male patients:
Show all 10Show fewer
  • 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.
  • 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).

Who cannot join

  • Patients are excluded from the study if any of the following criteria apply:
  • 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.
  • Have a history of chronic diarrheal disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  • Have had a positive diagnostic test for other GI pathogens, considered to be clinically relevant, within 2 weeks of randomization.
  • 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.
  • Have life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon.
Show all 17Show fewer
  • 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.
  • 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).
  • Prior or current use of anti-toxin antibodies including bezlotoxumab within the past 6 months prior to randomization.
  • Are unable to discontinue products used affecting disease progression at randomization.
  • 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.
  • Have received an investigational vaccine against C. difficile.
  • Patients that the Investigator feels are inappropriate for the study this would include those;
  • with any other condition that, in the Investigator's judgment, would make the patient unsuitable for inclusion in the study.
  • who, in the opinion of the Investigator, are not likely to complete the study for whatever reason, e.g. short life expectancy.
  • with known hypersensitivity or intolerance to ridinilazole, vancomycin, and/or their excipients
  • 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.

Trial locations and contacts

149 sites in 14 countries.

149 sites in 14 countries

United States49 sites
  • GI Alliance - Texas Digestive Disease Consultants - Arlington

    Arlington, Texas, 76012

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233

  • Mercury Street Medical Group PLLC

    Butte, Montana, 59701

  • GI Alliance - Texas Digestive Disease Consultants - Cedar Park

    Cedar Park, Texas, 78613

  • Chattanooga Research and Medicine CHARM

    Chattanooga, Tennessee, 37404-3230

  • DM Clinical Research (Conroe Regional Hospital)

    Conroe, Texas, 77304

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30333

  • Harper Hospital Department of Pharmacy Services

    Detroit, Michigan, 48201-2020

  • Detroit Receiving Hospital Department of Pharmacy Services

    Detroit, Michigan, 48201

  • Aa Mrc Llc

    Flint, Michigan, 48504-4730

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • GI Alliance - Illinois Gastro Group - Glenview

    Glenview, Illinois, 60026

  • ECU Adult Specialty Care

    Greenville, North Carolina, 27834

  • Grand Teton Research Group PLLC

    Idaho Falls, Idaho, 83404

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • FMC Science

    Lampasas, Texas, 76550

  • AB Clinical Trials

    Las Vegas, Nevada, 89119

  • Alliance Medical Research LLC

    Lighthouse PT, Florida, 33064

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

  • Infectious Diseases Associates of Central VA

    Lynchburg, Virginia, 24501

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Phoenix Medical Research LLC

    Miami, Florida, 33165

  • San Marcus Research

    Miami Lakes, Florida, 33014

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • Gasteroenterology Group of Naples

    Naples, Florida, 31402

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • New York Presbyterian Hospital Weill Cornell

    New York, New York, 10021

  • HeuerMD Research Inc

    Orlando, Florida, 32819

  • Pines Care Research Center Inc.

    Pembroke Pines, Florida, 33026

  • UnityPoint Health Peoria/Proctor

    Peoria, Illinois, 61603

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701

  • Paradigm Clinical Research Centers, Inc

    Redding, California, 96601

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073-6712

  • University Of California Davis

    Sacramento, California, 95817

  • GI Alliance - Texas Digestive Disease Consultants - San Marcos

    San Marcos, Texas, 78666

  • Bardmoor Gastroenterology

    Seminole, Florida, 33777

  • Revival Research Institute, LLC.

    Southfield, Michigan, 48034

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Professional Health Care of Pinellas

    St. Petersburg, Florida, 33713

  • GI Alliance - Arizona Digestive Health - Sun City

    Sun City, Arizona, 85351

  • James J. Peters VAMC

    The Bronx, New York, 10468

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • GI Alliance - Texas Digestive Disease Consultants - Webster

    Webster, Texas, 77598

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • St. Vincent Hospital

    Worcester, Massachusetts, 01608-1216

  • Florida Medical Clinic P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

South Korea15 sites
  • Hanyang University Seoul Hospital

    Ansan, Seoul, 04763

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355

  • Hallym University Kangnam Sacred Heart Hospital

    Anyang-si, Seoul, 07441

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon, Gangwon-do, 24253

  • Kyungpook National University Hospital

    Daegu, Seoul, 41944

  • Yeungnam University Medical Center

    Daegu, Seoul, 42415

  • Keimyung University Dongsan Hospital

    Daegu, Yeongnam, 42601

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do, 11923

  • Wonju Severance Christian Hospital

    Ilsan-dong, Gangwondo, 26426

  • Samsung Medical Center

    Irwon-dong, Seoul, 06351

  • Inje University Seoul Paik Hospital

    Junggu, 04551

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Kangdong Sacred Heart Hospital

    Seoul, 05355

  • Korea University Guro Hospital

    Soeul, 08307

  • Asan Medical Center

    Soeul, 5505

Other trials in South Korea

Poland12 sites
  • SP ZOZ w Bochni Szpital Powiatowy im. B. Marty Wieckiej

    Bochnia, 32-700

  • Szpital Bocheński SP ZOZ w Bochni

    Bochnia, 32-700

  • Klinika Chorób Zakaźnych i Hepatologii Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza

    Bydgoszcz, 85-030

  • Szpital Specjalistyczny w Chorzowie

    Chorzów, 41-500

  • Szpital Zakonu Bonifratrów

    Katowice, 40-211

  • Specjalistyczne Gabinety Sp z o.o.

    Krakow, 30-539

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszów, Podkarpackie Voivodeship, 35-302

  • Korczowski Bartosz Gabinet

    Rzeszów, 35-302

  • ENDOSKOPIA Sp. z o.o.

    Sopot, 81-756

  • Centralny Szpital Kliniczny MSWiA Klinika Chorób Wewnętrznych i Gastroenterologii

    Warsaw, 02-507

  • Klinika Chorób Wewnętrznych i Gastroenterologii z Pododdziałem Leczenia Nieswoistych Chorób Zapalnych Jelit Centralny Szpital Kliniczny MSWiA

    Warsaw, 02-507

  • Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego we Wrocławiu; I Oddział Chorób Zakaźnych

    Wroclaw, 51-149

Other trials in Poland

Hungary11 sites
  • Dr. Kenessey Albert Kórház Rendelőintézet, Tüdőgyógyászati Aktív Osztály

    Balassagyarmat, 2660

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház IV. Belgyógyászat - 2. Gasztroenterológia

    Békéscsaba, 5600

  • "Dél-Pesti Centrumkórház-OHII Szent László Kórház Infektológiai Osztály "

    Budapest, H-1097

  • Országos Korányi Pulmonológiai Intézet, Központi Intenzív osztály

    Budapest, H-1122

  • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház, Infektológia-Hepatológia Osztály

    Gyula, Bekes County, 5700

  • Pest Megyei Flór Ferenc Kórház, V. Belgyógyászat

    Kistarcsa, Pest County, 2143

  • CRU Hungary Kft BAZ Megyei Kórház és Egyetemi Oktatókórház, Szent Ferenc Tagkórház

    Miskolc, 3529

  • "Pécsi Tudományegyetem I. sz. Belgyógyászat i Klinika, Infektológiai tanszék"

    Pécs, H-7623

  • Pécsi Tudományegyetem Klinikai Központi Gyógyszertár

    Pécs, H-7624

  • Csongrad County Dr. Bugyi Istvan Hospital, Dept. Of Internal Medicine

    Szentes, H-6600

  • Javorszy Odon Hospital

    Vác, Vác, 2600

Other trials in Hungary

Romania9 sites
  • SUUMC-Boli infectioase

    Bucharest, 010825

  • Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"

    Bucharest, 030303

  • S.C. Sana Monitoring Srl

    Bucharest, 11025

  • Spitalul Clinic de Boli Infectioase si Tropicale

    Bucharest, 30303

  • Spitalul Minicipal Caracal

    Caracal, 235200

  • Spitalul Clinic de Boli Infectioase Constanta

    Constanța, 900709

  • Spitalul Clinic de Boli Infectioase- Sfanta Parascheva

    Iași, 700722

  • Spitalul Clinic de Boli Infectioase

    Iași, 700722

  • Spitalul Clinic Judetean de Urgenta Timisoara

    Timișoara, 300723

Other trials in Romania

Brazil8 sites
  • Unidade de Pesquisa - NCS - Hospital Felício Rocho

    Belo Horizonte, Minas Gerais, 30110-936

  • Hospital Vera Cruz

    Belo Horizonte, Minas Gerais, 30140-030

  • Santa Casa De Misericordia De Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150221

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020090

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande do Sul, 90160-092

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01327-001

Other trials in Brazil

Greece8 sites
  • General Hospital of Athens ''Evangelismos'

    Athens, 10676

  • General Hospital of Athens ''Alexandra''

    Athens, 115-28

  • "Pathophysiology Department Athens University Medical School"

    Athens, 11527

  • " ATTIKON University Hospital"

    Athens, 12462

  • "'Hygeia'' Hospital 2nd Department of Medicine and Infectious Diseases"

    Athens, 15121 Marousi

  • University Hospital of Heraklion

    Heraklion, 71110

  • University Hospital of Patras

    Pátrai, 265 04

  • ''Tzaneio'' General Hospital of Piraeus

    Piraeus, 185 -36

Other trials in Greece

Spain8 sites
  • Hospital Universitario Cruces

    Barakaldo, 48903

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Universitario Reina Sofía. Hospital Provincial

    Córdoba, 14004

  • "Hospital Universtiario Donostia "

    Donostia / San Sebastian, 20014

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • "Hospital Universitario Marqués de Valdecilla "

    Santander, 39008

  • Hospital Universitario de Balme

    Seville, Sevilla, 41014

  • Hospital Universitari Sant Joan de Reus

    Tarragona, 43204

Other trials in Spain

Canada7 sites
  • Foothills Medical Centre, South Tower

    Calgary, Alberta, T2N 2T9

  • Moncton Hospital/Horizon Health Network

    Moncton, New Brunswick, E1C 6Z8

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 1R9

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec- ULaval

    Québec, Quebec, G1V 4G5

  • Recherche Médicale St-Jérôme Inc

    Québec, Quebec, J7Z 5T3

  • Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Argentina6 sites
  • Instituto Medico Platense

    Buenos Aires, BI900AVG

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

  • Hospital Ramos Mejía

    Buenos Aires, C1221ADC

  • Hospital Privado Centro Medico Cordoba

    Córdoba, X5016KEH

  • Centro Médico Talar

    El Talar, Buenos Aires, 1608

  • Instituto Medico ALAS

    Salta, Argentina, CP4400

Other trials in Argentina

Australia6 sites
  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Monash Medical Center

    Clayton, Victoria, 3168

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Mater Misericordiae

    South Brisbane, Queensland, 4101

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Bulgaria5 sites
  • "MHAT - Blagoevgrad, EOOD Department of Gastroenterology"

    Blagoevgrad, 2700

  • MHAT "Sv.Ivan Rilski-2003"OOD

    Dupnitsa, Kyustendil, 2600

  • DCC1-Sliven Ltd.

    Sliven, Sliven, 8800

  • DCC Alexandrovska

    Sofia, Sofia, 1431

  • Medical center - Izgrev

    Sofia, 1612

Other trials in Bulgaria

New Zealand3 sites
  • Waikato District Health Board Waikato Hospital

    Hamilton, Waikato Region, 3240

  • Taranaki District Health Board TDHB - Taranaki Base Hospital

    New Plymouth, Taranki, 4310

  • Waitemata District Health Board WDHB North Shore Hospital

    Takapuna, Auckland, 0740

Other trials in New Zealand

Russia2 sites
  • " State Budgetary Institution of Healthcare "City Clinical Hospital of n.a. V.M.Buyanova" "

    Moscow, 115516

  • State budget healthcare institution of Novosibirsk region "City clinical hospital #2"

    Novosibirsk, 630051

Other trials in Russia

About this study

Official title: 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.

Read more

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.

Being tested
Ridinilazole, Vancomycin
Keywords
Clostridioides difficile, Clostridium difficile, C. difficile, C. diff
Medical subject headings
Clostridium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RidinilazoleDrug

    Also called 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

    ridinilazole (200 mg bid)

  • VancomycinDrug

    vancomycin (125 mg qid)

Study groups in NCT03595553
Study groupRoleWhat they receive
ridinilazoleExperimentalridinilazole 200mg bid
Receives: Drug: Ridinilazole
vancomycinActive comparatorvancomycin 125 mg qid
Receives: Drug: Vancomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    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.

    Measured: Day 40

Secondary outcomes (7)
  1. Clinical Response

    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.

    Measured: Day 12

  2. Clinical Cure

    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).

    Measured: Day 12

  3. Sustained Clinical Response Over 60 Days

    defined as Clinical Response and no recurrence of CDI through 60 days post EOT

    Measured: Day 70

  4. Sustained Clinical Response Over 90 Days

    defined as Clinical Response and no recurrence of CDI through 90 days post EOT

    Measured: Day 100

  5. Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT.

    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.

    Measured: Day 10

  6. Percentage of Change of α-diversity (Shannon Index) of the Microbiota in Stool Samples From Baseline to EOT.

    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

    Measured: Day 10

  7. Measure of β-diversity of the Gut Microbiota Between Baseline and EOT Stool Samples (Bray-Curtis Index/Dissimilarity).

    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.

    Measured: Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2018
  2. Study start28 Jan 2019
  3. Primary completion17 Nov 2021
  4. Study completion17 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03595553
Sponsor's protocol ID
SMT19969/C004
Other IDs
HHS0100201700014C
Acronym
Ri-CoDIFy 1
Status last verified
Oct 2026
First submitted
11 Jun 2018
Last updated
9 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Okhuysen PC, Ramesh MS, Louie T, Kiknadze N, Torre-Cisneros J, de Oliveira CM, Van Steenkiste C, Stychneuskaya A, Garey KW, Garcia-Diaz J, Li J, Duperchy E, Chang BY, Sukbuntherng J, Montoya JG, Styles L, Clow F, James D, Dubberke ER, Wilcox M. A Randomized, Double-Blind, Phase 3 Safety and Efficacy Study of Ridinilazole Versus Vancomycin for Treatment of Clostridioides difficile Infection: Clinical Outcomes With Microbiome and Metabolome Correlates of Response. Clin Infect Dis. 2024 Jun 14;78(6):1462-1472. doi: 10.1093/cid/ciad792.

    PubMed 38305378
  • Carlson TJ, Endres BT, Basseres E, Gonzales-Luna AJ, Garey KW. Ridinilazole for the treatment of Clostridioides difficile infection. Expert Opin Investig Drugs. 2019 Apr;28(4):303-310. doi: 10.1080/13543784.2019.1582640. Epub 2019 Feb 26.

    PubMed 30767587

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