Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024
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.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 27 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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)
Who cites it
27 citing papers in PubMed, 29 citations in OpenAlex.
- Safety and efficacy of CRS3123 in adults with a primary episode or first recurrence of Clostridioides difficile infection: a phase 2, randomised, double-blind, multicentre, vancomycin-controlled study.The Lancet. Infectious diseases · 2026Trial
- Trial
- Microbiome-based therapeutics forGut microbes · 2026Review
- Repurposing azole antifungals as rapid bactericidal, membrane-disruptive therapeutics againstMicrobiology spectrum · 2026Article
- Carbadox, a veterinary growth promoter exhibits anticlostridial activity through induction of oxidative stress in Clostridioides difficile.Gut pathogens · 2026Article
- Some Newer Antibiotics Active AgainstAntibiotics (Basel, Switzerland) · 2026Review
- Antibiotic-induced gut microbiome dysbiosis: risks and strategies for mitigation.The EMBO journal · 2026Review
- Dynamics of the microbiota in patients with Clostridioides difficile: Recurrence, treatment, sex, and immunosuppression.PLoS pathogens · 2026Article
- Clostridioides difficile pathogenesis and control.Nature reviews. Microbiology · 2026Review
- Practice Variations in the Management ofGastro hep advances · 2026Article
- Inhibition ofACS omega · 2025Article
- Repurposing of the bisbenzimide antibiotic Ridinilazole as an antiviral compound against human cytomegalovirus.The Journal of general virology · 2025Article
- C. difficile Infection in Colorectal Cancer: Risk Determinants, Outcomes, and Evolving Management Approaches.Journal of gastrointestinal cancer · 2025Review
- Experimental glycopeptide antibiotic EVG7 prevents recurrent Clostridioides difficile infection by sparing members of the Lachnospiraceae family.Nature communications · 2025Article
- Subgroup Analyses in Randomized Trials of Clostridioides difficile-Associated Disease: Recurring Challenges With Analyzing Recurrence.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Faecal pharmacokinetics, microbiome, and bile acid changes in healthy subjects given intravenous followed by oral omadacycline; a Phase 1 clinical trial.The Journal of antimicrobial chemotherapy · 2025Article
- Inhibition ofbioRxiv : the preprint server for biology · 2025Article
- The global resistance problem and the clinical antibacterial pipeline.Nature reviews. Microbiology · 2025Review
- What's Hot This Year in Infectious Diseases Clinical Science.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Review
- Risk factors and outcomes of Clostridioides difficile infection in patients with colorectal cancer: critical perspective in management.Gut pathogens · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 12 institutions in 7 countries.
Funding
Abstract
backgroundExposure to antibiotics predisposes to dysbiosis and Clostridioides difficile infection (CDI) that can be severe, recurrent (rCDI), and life-threatening. Nonselective drugs that treat CDI and perpetuate dysbiosis are associated with rCDI, in part due to loss of microbiome-derived secondary bile acid (SBA) production. Ridinilazole is a highly selective drug designed to treat CDI and prevent rCDI.
methodsIn this phase 3 superiority trial, adults with CDI, confirmed with a stool toxin test, were randomized to receive 10 days of ridinilazole (200 mg twice daily) or vancomycin (125 mg 4 times daily). The primary endpoint was sustained clinical response (SCR), defined as clinical response and no rCDI through 30 days after end of treatment. Secondary endpoints included rCDI and change in relative abundance of SBAs.
resultsRidinilazole and vancomycin achieved an SCR rate of 73% versus 70.7%, respectively, a treatment difference of 2.2% (95% CI: -4.2%, 8.6%). Ridinilazole resulted in a 53% reduction in recurrence compared with vancomycin (8.1% vs 17.3%; 95% CI: -14.1%, -4.5%; P = .0002). Subgroup analyses revealed consistent ridinilazole benefit for reduction in rCDI across subgroups. Ridinilazole preserved microbiota diversity, increased SBAs, and did not increase the resistome. Conversely, vancomycin worsened CDI-associated dysbiosis, decreased SBAs, increased Proteobacteria abundance (∼3.5-fold), and increased the resistome.
conclusionsAlthough ridinilazole did not meet superiority in SCR, ridinilazole greatly reduced rCDI and preserved microbiome diversity and SBAs compared with vancomycin. These findings suggest that treatment of CDI with ridinilazole results in an earlier recovery of gut microbiome health. Clinical Trials Registration.Ri-CoDIFy 1 and 2: NCT03595553 and NCT03595566.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.