Clinical Trials Logo

Clinical Trial Summary

This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent C. difficile infection (CDI) who have completed a standard of care course of CDI antibiotics and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug.


Clinical Trial Description

This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent CDI (primary [meaning the first occurrence they have had] or recurrent infection) who have completed a standard of care course of CDI antibiotics (vancomycin, fidaxomicin, or metronidazole administered for 10 to 21 days) and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug. Subjects will receive study drug in the following 2 sequential cohorts: - Cohort A: ART24 or placebo once daily for 7 days (8 subjects) - Cohort B: ART24 or placebo once daily for 28 days (28 subjects) In each cohort, subjects will be randomized in a ratio of 3 [active]:1 [placebo]. Subjects who are randomized to active treatment in both cohorts will receive ART24 (5×10^9 colony-forming units [CFU]) daily. Initiation of Cohort B will only occur once the Data Review Committee (DRC) has evaluated blinded safety data (through Week 2) from Cohort A and recommends that the study proceed to the next cohort. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04891965
Study type Interventional
Source Adiso Therapeutics
Contact
Status Completed
Phase Phase 1
Start date February 27, 2020
Completion date October 13, 2022

See also
  Status Clinical Trial Phase
Terminated NCT04000555 - Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI) Phase 4
Terminated NCT03065374 - Treatment for Clostridium-difficile Infection With IMM529 Phase 1/Phase 2
Not yet recruiting NCT05606159 - Bacillus Velezensis DSM 33864 for Reduction of the Risk of Recurrent Clostridioides Difficile Infections N/A
Completed NCT03110133 - Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff Phase 2
Recruiting NCT06237452 - VE303 for Prevention of Recurrent Clostridioides Difficile Infection Phase 3
Completed NCT03880539 - Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection Phase 4
Not yet recruiting NCT04415918 - Bezlotoxumab Efficacy and Tolerability in Cancer Patient Phase 4
Recruiting NCT03562741 - Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile N/A
Completed NCT03788434 - Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection Phase 2
Completed NCT04317963 - Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection
Completed NCT03617445 - Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients Phase 2
Recruiting NCT05831189 - A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection Phase 3