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| ID | Type | Description | Link |
|---|---|---|---|
| #15-03 | Other Identifier | VA Central IRB | |
| 1613088 | Other Identifier | Hines R&DC |
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The study sponsor stopped the trial early after enrolling 308 of the target sample size because of a slower than expected recruitment rate.
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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.
Abstract Clostridium difficile is the most common cause of healthcare-associated infectious diarrhea among adults in industrialized countries. In addition to diarrhea, C. difficile infection (CDI) may also result in serious complications such as shock, toxic megacolon, colectomy, and death. The Centers for Disease Control and Prevention (CDC) has estimated C. difficile results in 250,000 hospital infections, 14,000 deaths, and $1 billion in excess costs annually. Recurrent CDI is the most challenging clinical dilemma facing clinicians who treat this disease. An estimated 30% of patients who respond to initial treatment with either vancomycin or metronidazole develop recurrent CDI, usually within 1-4 weeks of completing treatment.
The primary objective of this study is to determine whether 1) standard fidaxomicin treatment and 2) standard vancomycin treatment followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment alone for sustained clinical response at day 59 for all treatments, for participants with either their first or second recurrence of CDI. Veterans presenting with a first or second CDI recurrence will be screened, consented and randomly assigned in a double-blind manner equally to one of three treatment groups: 1) a 10 day course of oral vancomycin (VAN-TX), 2) a 10 day course of fidaxomicin (FID-TX) or 3) a 31 day course of vancomycin which includes a taper and pulse following daily treatment (VAN-TP/P). Symptom resolution is defined as an improvement or resolution of diarrhea ( 3 unformed bowel movements over 24 hours) for 48 consecutive hours compared to the participant's baseline. Recurrence is defined as having diarrhea (>3 loose or semi-formed stools over 24 hours for 48 consecutive hours). A sample size of 459 randomized study participants is required to obtain 91% global power to detect a 16% absolute difference (expected proportion of 31% in the VAN-TX group) in sustained clinical response (D- COM) proportion for at least one comparison (VAN-TP/P vs. VAN-TX, FID-TX vs. VAN-TX) at the family wised error rate (FWER) 0.05 level. The marginal probability (disjunctive power) of detecting 16% absolute difference for each comparison is 81%. The expected withdrawal rate prior to day 59 (prior outcome assessment) is estimated to be 10%. If both FID-TX and VAN-TP/P are found to be superior to VAN-TX, then the non-inferiority of VAN-TP/P to FID-TX will be assessed.
With the assumption that sites recruit 4 participants (site average) per year for sites primarily recruiting from the main hospital and nearby CBOCS, and 6 participants (site average) per year for sites that could partner with independent VAMCs (Independent VAMCs LSI Application will be reviewed and approved by Central IRB) that are close in distance to allow a shared site coordinator (WOC appointed) at an increased funding level, the study is expected to complete enrollment of 459 participants within 6 years with 90 days of follow-up. This includes 2 years of pilot phase plus transitioning period from pilot phase to full study, and 4 years of full study. There were 6 sites in the pilot phase and will have 24 units (26 sites) in full phase (including 5 pilot sites and 21 additional sites). Sites that are significantly below the recruitment target for an extensive period may be considered for termination. The recruitment timeline and the number of sites will be re-evaluated based on the actual recruitment rate, the number of sites still recruiting, whether replacement or additional sites will be added, the study time period on administrative recruitment hold due to COVID-19 pandemic, and available funding resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fidaxomicin | Other | Standard 10-day fidaxomicin treatment for Clostridium difficile |
|
| Vancomycin T/P | Other | Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile |
|
| Vancomycin | Other | Standard 10-day vancomycin treatment for Clostridium difficile |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fidaxomicin | Drug | 200 mg PO twice daily for 10 days |
| |
| Vancomycin with Taper/Pulse |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Clinical Response as Measured at Study Day 59 for All Treatment Regimens | 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):
| Day 59 for all treatment regimens. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Diarrhea Composite Outcome (D-COM) at 28 Days Post End of Therapy | Sustained Diarrhea Composite Outcome (D-COM) at 28 days Post End of Therapy- Secondary Analyses of Primary Outcome. Sustained clinical response without recurrent CDI (CDI-COM) at 28 days post end of therapy for all three treatment regimens. Sustained clinical response was defined using the same criteria as previously stated except that the endpoint will be 28 days after the last dose of treatment drug for each treatment arm (day 38 for vancomycin and fidaxomicin, and day 59 for vancomycin taper/pulse).Sustained clinical response is a composite endpoint defined as symptom resolution during treatment without diarrhea recurrence, mortality or other important clinical outcomes at any time during the follow-up period. Those participants failing to meet the criteria of symptom resolution (diarrhea resolution) by the end of the active treatment (day 10 for all groups), or who experience a recurrence during the follow-up period, will be considered study treatment failures. |
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Inclusion Criteria:
Informed consent obtained and signed
Age > 18
If female, participant must not be pregnant or nursing
Confirmed current diagnosis of CDI, determined by having
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
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Stuart B. Johnson, MD BA | Edward Hines Jr. VA Hospital, Hines, IL | Study Chair |
| Dale N Gerding, MD | Edward Hines Jr. VA Hospital, Hines, IL | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix VA Health Care System, Phoenix, AZ | Phoenix | Arizona | 85012 | United States | ||
| Southern Arizona VA Health Care System, Tucson, AZ |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35398532 | Background | Johnson S, Gerding DN, Li X, Reda DJ, Donskey CJ, Gupta K, Goetz MB, Climo MW, Gordin FM, Ringer R, Johnson N, Johnson M, Calais LA, Goldberg AM, Ge L, Haegerich T. Defining optimal treatment for recurrent Clostridioides difficile infection (OpTION study): A randomized, double-blind comparison of three antibiotic regimens for patients with a first or second recurrence. Contemp Clin Trials. 2022 May;116:106756. doi: 10.1016/j.cct.2022.106756. Epub 2022 Apr 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fidaxomicin | Standard 10-day fidaxomicin treatment for Clostridium difficile Fidaxomicin: 200 mg PO twice daily for 10 days |
| FG001 | Vancomycin T/P | Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2025 | Dec 11, 2025 |
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| Drug |
125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days |
|
| Vancomycin | Drug | 125 mg PO for times daily for 10 days |
|
| 28 Days Post End of Therapy |
| Clostridium Difficile Infection Composite Outcome (CDI-COM) | Clostridium difficile Infection Composite Outcome (CDI-COM) at day 59 post randomization. Sustained response in CDI-COM is defined using the same composite endpoint criteria as was used in the D-COM composite outcome but with confirmation of no CDI recurrence by a negative C. difficile stool assay test (i.e., proportion of subjects who achieve symptom resolution by day 10 without recurrent CDI, without non-fatal clinical events, and without death). | Day 59 post randomization |
| Symptom Resolution | The percentage of participants who had symptom resolution by Day 10 post randomization | Day 10 since randomization |
| CDI Recurrence | CDI recurrence following initial symptom resolution | Day 90 since randomization |
| Diarrhea Recurrence | Diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution | Day 90 since randomization |
| 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. The HRQOL is measured with patient self-reported 32-item questionnaire. The summary measure, CDiff32-QOL, is the total score that sums over 32 individual items with each item rated on a 5-point Likert scale and then transformed to a 100-point scale with higher score indicating better C.diff Health Related QOL in general. The full scale of the HRQOL: 1-5 on a 5-point Likert scale and 0-100 on the 100-point scale; the minimum: 0 on the 100-point scale and maximum value: 100 on the 100-point scale. The summary measure (32 items) range on the 100-point scale: 0-3200. | Day 10 since randomization |
| 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. The HRQOL is measured with patient self-reported 32-item questionnaire. The summary measure, CDiff32-QOL, is the total score that sums over 32 individual items with each item rated on a 5-point Likert scale and then transformed to a 100-point scale with higher score indicating better C.diff Health Related QOL in general. The full scale of the HRQOL: 1-5 on a 5-point Likert scale and 0-100 on the 100-point scale; the minimum: 0 on the 100-point scale and maximum value: 100 on the 100-point scale. The summary measure (32 items) range on the 100-point scale: 0-3200. | day 0- day 59 |
| Sustained Clinical Response (D-COM) BI/NAP1/027 Strain as "Yes" | Sustained clinical response (D-COM) at day 59 for subgroups (infection with the BI/NAP1/027 strain (yes) at study enrollment; etc.). The sliced analysis was used to break down the subgroup factors into different sub-levels and then to explore the differences between treatment group (VAN-TP and FDX) and VAN control group at each level. | Day 59 since randomization |
| Diarrhea Recurrence | Diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution. Diarrhea recurrence and diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution. Diarrhea (>3 loose or semi-formed stools over 24 hours) over 48 consecutive hours in participants who achieved initial symptom resolution will be recorded separately from sustained clinical response as will confirmed CDI recurrence. | Day 38 since randomization |
| Diarrhea Recurrence | Diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution | Day 59 since randomization |
| CDI Recurrence | CDI recurrence following initial symptom resolution | Day 38 since randomization |
| CDI Recurrence | CDI recurrence following initial symptom resolution | Day 59 since randomization |
| Sustained Clinical Response (D-COM) With the BI/NAP1/027 Strain no | Sustained clinical response (D-COM) at day 59 for subgroups (infection with the BI/NAP1/027 strain (no) at study enrollment; etc.). The sliced analysis was used to break down the subgroup factors into different sub-levels and then to explore the differences between therapy group (VAN-TP and FDX) and VAN control group at each level. | Day 59 since randomization |
| Sustained Diarrhea Composite Outcome (D-COM) at 90 Days After Randomization | Sustained Diarrhea Composite Outcome (D-COM) at 90 days after Randomization - Secondary Analyses of Primary Outcome | 90 Days After Randomization |
| Tucson |
| Arizona |
| 85723-0001 |
| United States |
| Central Arkansas Veterans Healthcare System, Little Rock, AR | Little Rock | Arkansas | 72205 | United States |
| VA Loma Linda Healthcare System, Loma Linda, CA | Loma Linda | California | 92357 | United States |
| VA Long Beach Healthcare System, Long Beach, CA | Long Beach | California | 90822 | United States |
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States |
| VA Northern California Health Care System, Mather, CA | Sacramento | California | 95655-4200 | United States |
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | United States |
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045-7211 | United States |
| Bay Pines VA Healthcare System, Pay Pines, FL | Bay Pines | Florida | 33744-0000 | United States |
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida | 32608-1135 | United States |
| James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida | 33612 | United States |
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033-4004 | United States |
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | United States |
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141-3030 | United States |
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141 | United States |
| Rehabilitation R&D Service, Baltimore, MD | Baltimore | Maryland | 21202 | United States |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130-4817 | United States |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States |
| John D. Dingell VA Medical Center, Detroit, MI | Detroit | Michigan | 48201-1916 | United States |
| Asheville VA Medical Center, Asheville, NC | Asheville | North Carolina | 28805-2576 | United States |
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | United States |
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106-1702 | United States |
| Oklahoma City VA Medical Center, Oklahoma City, OK | Oklahoma City | Oklahoma | 73104-5007 | United States |
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97207-2964 | United States |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216-7167 | United States |
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | United States |
| South Texas Health Care System, San Antonio, TX | San Antonio | Texas | 78229 | United States |
| VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah | 84148 | United States |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
| Clement J. Zablocki VA Medical Center, Milwaukee, WI | Milwaukee | Wisconsin | 53295-0001 | United States |
| VA Caribbean Healthcare System, San Juan, PR | San Juan | 00921 | Puerto Rico |
| FG002 | Vancomycin | Standard 10-day vancomycin treatment for Clostridium difficile Vancomycin: 125 mg PO for times daily for 10 days |
| Modified Intent-To-Treat |
|
| Safety Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fidaxomicin | Standard 10-day fidaxomicin treatment for Clostridium difficile Fidaxomicin: 200 mg PO twice daily for 10 days |
| BG001 | Vancomycin T/P | Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days |
| BG002 | Vancomycin | Standard 10-day vancomycin treatment for Clostridium difficile Vancomycin: 125 mg PO for times daily for 10 days |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | One participant in Fidaxomicin with missing race information | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Sustained Clinical Response as Measured at Study Day 59 for All Treatment Regimens | 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):
| mITT Primary Analysis: Missing primary outcome D-COM at Day 59 in the mITT analysis was imputed by an imputation model. mITT Sensitivity Analysis 1: Missing primary outcome D-COM at Day 59 was treated as failure. mITT Sensitivity Analysis 2: Missing outcomes were excluded as a complete case analysis. PP analysis: Participants who 1) failed to respond by day 10 or completed day 59 follow-up and (2) took 80% of their assigned drug according to the pill count (Per-Protocol population). | Posted | Count of Participants | Participants | Day 59 for all treatment regimens. |
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| Secondary | Sustained Diarrhea Composite Outcome (D-COM) at 28 Days Post End of Therapy | Sustained Diarrhea Composite Outcome (D-COM) at 28 days Post End of Therapy- Secondary Analyses of Primary Outcome. Sustained clinical response without recurrent CDI (CDI-COM) at 28 days post end of therapy for all three treatment regimens. Sustained clinical response was defined using the same criteria as previously stated except that the endpoint will be 28 days after the last dose of treatment drug for each treatment arm (day 38 for vancomycin and fidaxomicin, and day 59 for vancomycin taper/pulse).Sustained clinical response is a composite endpoint defined as symptom resolution during treatment without diarrhea recurrence, mortality or other important clinical outcomes at any time during the follow-up period. Those participants failing to meet the criteria of symptom resolution (diarrhea resolution) by the end of the active treatment (day 10 for all groups), or who experience a recurrence during the follow-up period, will be considered study treatment failures. | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | 28 Days Post End of Therapy |
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| Secondary | Clostridium Difficile Infection Composite Outcome (CDI-COM) | Clostridium difficile Infection Composite Outcome (CDI-COM) at day 59 post randomization. Sustained response in CDI-COM is defined using the same composite endpoint criteria as was used in the D-COM composite outcome but with confirmation of no CDI recurrence by a negative C. difficile stool assay test (i.e., proportion of subjects who achieve symptom resolution by day 10 without recurrent CDI, without non-fatal clinical events, and without death). | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | Day 59 post randomization |
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| Secondary | Symptom Resolution | The percentage of participants who had symptom resolution by Day 10 post randomization | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | Day 10 since randomization |
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| Secondary | CDI Recurrence | CDI recurrence following initial symptom resolution | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | Day 90 since randomization |
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| Secondary | Diarrhea Recurrence | Diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | Day 90 since randomization |
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| 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. The HRQOL is measured with patient self-reported 32-item questionnaire. The summary measure, CDiff32-QOL, is the total score that sums over 32 individual items with each item rated on a 5-point Likert scale and then transformed to a 100-point scale with higher score indicating better C.diff Health Related QOL in general. The full scale of the HRQOL: 1-5 on a 5-point Likert scale and 0-100 on the 100-point scale; the minimum: 0 on the 100-point scale and maximum value: 100 on the 100-point scale. The summary measure (32 items) range on the 100-point scale: 0-3200. | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Mean | Standard Deviation | units on a scale | Day 10 since randomization |
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| 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. The HRQOL is measured with patient self-reported 32-item questionnaire. The summary measure, CDiff32-QOL, is the total score that sums over 32 individual items with each item rated on a 5-point Likert scale and then transformed to a 100-point scale with higher score indicating better C.diff Health Related QOL in general. The full scale of the HRQOL: 1-5 on a 5-point Likert scale and 0-100 on the 100-point scale; the minimum: 0 on the 100-point scale and maximum value: 100 on the 100-point scale. The summary measure (32 items) range on the 100-point scale: 0-3200. | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Mean | Standard Deviation | units on a scale | day 0- day 59 |
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| Secondary | Sustained Clinical Response (D-COM) BI/NAP1/027 Strain as "Yes" | Sustained clinical response (D-COM) at day 59 for subgroups (infection with the BI/NAP1/027 strain (yes) at study enrollment; etc.). The sliced analysis was used to break down the subgroup factors into different sub-levels and then to explore the differences between treatment group (VAN-TP and FDX) and VAN control group at each level. | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | Day 59 since randomization |
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| Secondary | Diarrhea Recurrence | Diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution. Diarrhea recurrence and diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution. Diarrhea (>3 loose or semi-formed stools over 24 hours) over 48 consecutive hours in participants who achieved initial symptom resolution will be recorded separately from sustained clinical response as will confirmed CDI recurrence. | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | Day 38 since randomization |
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| Secondary | Diarrhea Recurrence | Diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | Day 59 since randomization |
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| Secondary | CDI Recurrence | CDI recurrence following initial symptom resolution | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | Day 38 since randomization |
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| Secondary | CDI Recurrence | CDI recurrence following initial symptom resolution | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | Day 59 since randomization |
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| Secondary | Sustained Clinical Response (D-COM) With the BI/NAP1/027 Strain no | Sustained clinical response (D-COM) at day 59 for subgroups (infection with the BI/NAP1/027 strain (no) at study enrollment; etc.). The sliced analysis was used to break down the subgroup factors into different sub-levels and then to explore the differences between therapy group (VAN-TP and FDX) and VAN control group at each level. | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | Day 59 since randomization |
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| Secondary | Sustained Diarrhea Composite Outcome (D-COM) at 90 Days After Randomization | Sustained Diarrhea Composite Outcome (D-COM) at 90 days after Randomization - Secondary Analyses of Primary Outcome | mITT Complete Case Analysis with missing outcome excluded, number of participants in population would be different in other mITT complete case analysis populations because timeline for data collection and outcome variables were different. | Posted | Count of Participants | Participants | 90 Days After Randomization |
|
8 years, 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fidaxomicin | Standard 10-day fidaxomicin treatment for Clostridium difficile Fidaxomicin: 200 mg PO twice daily for 10 days | 8 | 102 | 34 | 102 | 7 | 102 |
| EG001 | Vancomycin T/P | Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days | 2 | 100 | 30 | 100 | 15 | 100 |
| EG002 | Vancomycin | Standard 10-day vancomycin treatment for Clostridium difficile Vancomycin: 125 mg PO for times daily for 10 days | 3 | 100 | 27 | 100 | 12 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Mycardinal infection | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper Gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| chest pain | General disorders | Systematic Assessment |
| ||
| complication associated with device | General disorders | Systematic Assessment |
| ||
| death | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Physical deconditioning | General disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Sepsis syndrome | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Urosepsis | Infections and infestations | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Cardiac valve vegetation | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Clostridial sepsis | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alcohol poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Renal lymphocele | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkaliemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypervolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| metabolic encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Alcohol abuse | Psychiatric disorders | Systematic Assessment |
| ||
| Alcohol withdrawal | Psychiatric disorders | Systematic Assessment |
| ||
| Substance abuse | Psychiatric disorders | Systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| End stage renal disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic Obstructive Pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Homeless | Social circumstances | Systematic Assessment |
| ||
| Alcohol detoxification | Surgical and medical procedures | Systematic Assessment |
| ||
| Amputation | Surgical and medical procedures | Systematic Assessment |
| ||
| Intraocular Lens Implant | Surgical and medical procedures | Systematic Assessment |
| ||
| Knee Arthroplasty | Surgical and medical procedures | Systematic Assessment |
| ||
| Arteriovenous fistula operation | Surgical and medical procedures | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypotension | Vascular disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
| ||
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Colon cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Decubitus ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Catheterisation cardiac | Investigations | Systematic Assessment |
| ||
| Device occlusion | Product Issues | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment | Mild |
| |
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment | Moderate |
| |
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment | Mild |
| |
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment | Moderate |
| |
| Dysepsia | Gastrointestinal disorders | Systematic Assessment | Mild |
| |
| Nausea | Gastrointestinal disorders | Systematic Assessment | Mild |
| |
| Nausea | Gastrointestinal disorders | Systematic Assessment | Moderate |
| |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Mild |
| |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Severe |
| |
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Moderate |
| |
| Frequent bowel movements | Gastrointestinal disorders | Systematic Assessment | Mild |
| |
| Clostridioide difficile infection | Infections and infestations | Systematic Assessment | Moderate |
| |
| Fungal infection | Infections and infestations | Systematic Assessment | Mild |
| |
| Conjunctivitis | Infections and infestations | Systematic Assessment | Mild |
| |
| Hepatic enzyme increased | Investigations | Systematic Assessment | Mild |
| |
| White blood cell count | Investigations | Systematic Assessment | Mild |
| |
| White blood cell count | Investigations | Systematic Assessment | Moderate |
| |
| Alanine aminotransferase | Investigations | Systematic Assessment | Mild |
| |
| Aspartate aminotransferase | Investigations | Systematic Assessment | Mild |
| |
| Neutrophil count decrease | Investigations | Systematic Assessment | Severe |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild |
| |
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild |
| |
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment | Moderate |
| |
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild |
| |
| Tachycardia | Cardiac disorders | Systematic Assessment | Moderate |
| |
| Fatigue | General disorders | Systematic Assessment | Mild |
| |
| Malaise | General disorders | Systematic Assessment | Moderate |
| |
| Hepatic steatosis | Hepatobiliary disorders | Systematic Assessment | Mild |
| |
| Tremor | Nervous system disorders | Systematic Assessment | Mild |
| |
| Emotional distress | Psychiatric disorders | Systematic Assessment | Mild |
| |
| Hypotension | Vascular disorders | Systematic Assessment | Moderate |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stuart Johnson | Hines VA | 708--202-8387 | 257772 | Stuart.Johnson2@va.gov |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2021 | Aug 4, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077732 | Fidaxomicin |
| D014640 | Vancomycin |
| D011674 | Pulse |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061065 | Polyketides |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
Not provided
Not provided
|
|
|
| African American |
|
|
| Other |
|
|
| mITT Sensitivity Analysis 1 |
|
|
| mITT Sensitivity Analysis 2 |
|
|
| PP Analysis |
|
|
| OG001 | Fidaxomicin | Standard 10-day fidaxomicin treatment for Clostridium difficile Fidaxomicin: 200 mg PO twice daily for 10 days |
| OG002 | Vancomycin | Standard 10-day vancomycin treatment for Clostridium difficile Vancomycin: 125 mg PO for times daily for 10 days |
|
|
Standard 10-day vancomycin treatment for Clostridium difficile Vancomycin: 125 mg PO for times daily for 10 days |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 | Vancomycin | Standard 10-day vancomycin treatment for Clostridium difficile Vancomycin: 125 mg PO for times daily for 10 days |
|
|
| OG002 | Vancomycin | Standard 10-day vancomycin treatment for Clostridium difficile Vancomycin: 125 mg PO for times daily for 10 days |
|
|
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
|
Standard 10-day vancomycin treatment for Clostridium difficile Vancomycin: 125 mg PO for times daily for 10 days |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
Standard 10-day vancomycin treatment for Clostridium difficile
Vancomycin: 125 mg PO for times daily for 10 days
|
|
| Units | Counts |
|---|---|
| Participants |
|
|