Vancomycin Clinical Trial
— OpTIONOfficial title:
CSP #596 - Optimal Treatment for Recurrent Clostridium Difficile Infection
The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.
Status | Recruiting |
Enrollment | 549 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Informed consent obtained and signed - Age > 18 - If female, participant must not be pregnant or nursing - Negative pregnancy test required for females <61 years of age or without prior hysterectomy - Confirmed current diagnosis of CDI, determined by having - >3 loose or semi-formed stools for participants over 24 hours AND - Positive stool assay for C. difficile - EIA positive for toxin A/B; or - Cytotoxin assay; or - Nucleic Acid Amplification Test (NAAT, PCR or LAMP) based detection of toxigenic C. difficile - Current episode represents the first recurrent episode of CDI within 3 months of the primary CDI episode in a patient who has not had CDI in the 3 months prior to the primary episode OR a second recurrent CDI episode occurring within 3 months of the first recurrent episode, as defined above - At least one of the previous CDI episodes must have been confirmed by a stool assay for C. difficile Exclusion Criteria: - Inability to provide informed consent - Inability to take oral capsules - Receipt of >72 hours of antibiotics considered effective in the treatment of CDI, including: - metronidazole - vancomycin - fidaxomicin - nitazoxanide - rifaximin - Prior infusion of bezlotoxumab within the previous 6 months - Known presence of fulminant CDI, including hypotension, severe ileus or GI obstruction or incipient toxic megacolon - Receipt of more than a single course of oral vancomycin, fidaxomicin, or a vancomycin tapering regimen since the primary episode of CDI as defined above - Known allergy to vancomycin or fidaxomicin - Acute or chronic diarrhea due to inflammatory bowel disease or other cause (e.g., presence of an ileostomy or colostomy) that would confound evaluation of response to CDI treatment - Anticipation of need for long term systemic antibiotic treatment (beyond 7 days) - Patients with an active diagnosis of COVID-19 will be excluded from the study, but patients who have recovered (per current CDC guidance on discontinuation of transmission-based precautions) can be included in the study. |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | VA Caribbean Healthcare System, San Juan, PR | San Juan | |
United States | VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan |
United States | Asheville VA Medical Center, Asheville, NC | Asheville | North Carolina |
United States | Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado |
United States | Rehabilitation R&D Service, Baltimore, MD | Baltimore | Maryland |
United States | Bay Pines VA Healthcare System, Pay Pines, FL | Bay Pines | Florida |
United States | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts |
United States | Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois |
United States | Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio |
United States | VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas |
United States | Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia |
United States | John D. Dingell VA Medical Center, Detroit, MI | Detroit | Michigan |
United States | Durham VA Medical Center, Durham, NC | Durham | North Carolina |
United States | North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida |
United States | Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois |
United States | Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois |
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
United States | Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR | Little Rock | Arkansas |
United States | VA Loma Linda Healthcare System, Loma Linda, CA | Loma Linda | California |
United States | VA Long Beach Healthcare System, Long Beach, CA | Long Beach | California |
United States | Clement J. Zablocki VA Medical Center, Milwaukee, WI | Milwaukee | Wisconsin |
United States | Oklahoma City VA Medical Center, Oklahoma City, OK | Oklahoma City | Oklahoma |
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
United States | Phoenix VA Health Care System, Phoenix, AZ | Phoenix | Arizona |
United States | VA Portland Health Care System, Portland, OR | Portland | Oregon |
United States | VA Northern California Health Care System, Mather, CA | Sacramento | California |
United States | VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah |
United States | South Texas Health Care System, San Antonio, TX | San Antonio | Texas |
United States | VA San Diego Healthcare System, San Diego, CA | San Diego | California |
United States | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington |
United States | James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida |
United States | Southern Arizona VA Health Care System, Tucson, AZ | Tucson | Arizona |
United States | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine symptom resolution during treatment without any of the following: diarrhea recurrence; other non-fatal clinical events including severe abdominal pain, toxic megacolon, and colectomy; and death. | The Primary outcome will be sustained clinical response as measured at study day 59 for all treatment regimens. Sustained clinical response is a composite outcome that includes symptom resolution during treatment without any of the following (as assessed on day 59):
Diarrhea recurrence Other non-fatal clinical events including severe abdominal pain, toxic megacolon (where diarrhea ceases but is not a beneficial outcome), and colectomy Death |
Day 59 for all treatment regimens. | |
Secondary | CDI Composite outcome measure | CDI Composite Outcome Measure (CDI-COM) is sustained clinical response without recurrent CDI (defined as diarrhea plus confirmation of toxigenic C. difficile or its toxins in stool) as measured at study day 59 for all three treatment regimens. Sustained response will be defined using the same composite endpoint criteria as were used in the D-COM outcome but without recurrent CDI on or before day 59. | Day 59 for all treatment regimens. | |
Secondary | Diarrhea Composite outcome measure | Sustained clinical response in Diarrhea Composite Outcome (D-COM) at 28 days post end of therapy | Day 38 since randomization for vancomycin and fidaxomicin, day 59 since randomization for vancomycin followed by tapering and pulse dose regimen | |
Secondary | Diarrhea Composite outcome measure | Sustained clinical response in Diarrhea Composite Outcome (D-COM) at 90 days post randomization | Day 90 since randomization | |
Secondary | CDI Composite outcome measure | Sustained clinical response in CDI Composite Outcome (CDI-COM) at 28 days post end of therapy. Sustained response in CDI-COM is defined using the same composite endpoint criteria as was used in the D-COM composite outcome (primary outcome) but with confirmation of no CDI recurrence by a negative C. difficile stool assay test. | Day 38 since randomization for vancomycin and fidaxomicin, day 59 since randomization for vancomycin followed by tapering and pulse dose regimen | |
Secondary | CDI Composite outcome measure | Sustained clinical response in CDI Composite Outcome (CDI-COM) at 59 days post randomization | Day 59 since randomization | |
Secondary | CDI Composite outcome measure | Sustained clinical response in CDI Composite Outcome (CDI-COM) at 90 days post randomization | Day 90 since randomization | |
Secondary | Symptom resolution | Proportion of subjects with symptom resolution by day 10 | Day 10 since randomization | |
Secondary | Symptom resolution | Days from randomization to symptom resolution | Day 10 since randomization | |
Secondary | Symptom resolution | Diarrhea recurrence following initial symptom resolution | Day 90 since randomization | |
Secondary | Diarrhea recurrence | Diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution | Day 90 since randomization | |
Secondary | C.diff Health Related Quality of Life (HRQOL) | Change in patient reported C.diff Health Related Quality of Life (HRQOL) from baseline (day 0) to day 10 | Day 90 since randomization | |
Secondary | C.diff Health Related Quality of Life (HRQOL) | Change in patient reported C.diff Health Related Quality of Life (HRQOL) from baseline (day 0) to day 59 | Day 90 since randomization | |
Secondary | Sustained clinical response (D-COM) | Sustained clinical response (D-COM) at day 59 for subgroups (infection with the BI/NAP1/027 strain (yes, no) at study enrollment; etc.) | Day 59 since randomization | |
Secondary | Sustained clinical response (CDI-COM) | Sustained clinical response (CDI-COM) at day 59 for subgroups (infection with the BI/NAP1/027 strain (yes, no) at study enrollment; etc.) | Day 59 since randomization |
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