Clostridium Difficile InfectionPhase 2/3NCT07221370
Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients
A Phase 2/3 study testing Vancomycin 125mg in people with Clostridium Difficile Infection and Vancomycin Resistant Enterococci Infection, run by Riverside University Health System Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine if oral vancomycin can prevent C.diff infection in adults who are critically ill and are at high risk of C.diff infection due to their medical conditions and being in the hospital. It will also help us learn about the safety of the drug in this setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection, Vancomycin Resistant Enterococci Infection
- What is being tested?
- Vancomycin 125mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Must meet all 3 criteria:
- Adults aged 18 years and older.
- Receiving ≥ 72 hours of a systemic antibiotic during index hospitalization.
- Admitted ≥ 72 hours into their index hospitalization.
- And must meet 2 additional of the following high-risk criteria
- Age ≥ 65 years
Show all 15Show fewer
- Previous residence in long-term care facility
- Previous proton pump inhibitor use (chronic or as needed)
- Inflammatory bowel disease
- Immunocompromised state (HIV/AIDS; transplant recipient; receipt of prednisone 20 mg daily for at least one month, immunosuppressants, or chemotherapy)
- End stage renal disease (ESRD)
- Diabetes mellitus
- Receipt of catecholamines (norepinephrine at a rate of ≥ 5 mcg/min)
- Hospitalized ≤ 30 days prior to the index hospitalization.
- Received systemic antibiotics during that prior hospitalization.
Who cannot join
- Pregnant or breastfeeding women
- Currently incarcerated individuals
- Individual or legal representative whose informed consent cannot be obtained
- Subject not expected to survive the ICU stay or subject likely to be considered for palliative or hospice care
- Receiving concurrent treatment with metronidazole for any indication
- One-time empiric use of metronidazole is allowed and does not constitute an exclusion criterion
Show all 11Show fewer
- Receiving concurrent probiotics
- Allergic reaction or had a contraindication for use of enteral vancomycin
- History of prior CDI within the past 90 days of randomization
- Had suspected active CDI prior to inclusion
- Infection requiring more than 14 21 days of systemic antibiotics during index hospitalization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Riverside University Health System
Moreno Valley, California, 92373
Suman B Thapamagar, MBBS, 9514864000, suman.thapamagar@ruhealth.org
Brian Phan, PharmD, 9514864000, b.pham@ruhealth.org
About this study
The goal of this clinical trial is to determine if oral vancomycin can prevent C.diff infection in adults who are critically ill and are at high risk of C.diff infection due to their medical conditions and being in the hospital. It will also help us learn about the safety of the drug in this setting. The main questions the trial aims to answer are:
- Does oral vancomycin lower the rate of C.diff infection in high-risk patients?
- Does C.diff carrier status change the C.diff infection rate as well as clearance of carrier status when vancomycin is used as primary prophylaxis? Researchers will compare the oral, active drug vancomycin to a placebo (a look-alike substance that contains no drug) to determine if vancomycin works to prevent C.diff infection in the hospital.
Read more
Participants will:
- Take oral vancomycin or a placebo while they receive systemic antibiotic(s) for up to five days after the last dose of said systemic antibiotic(s). The treatment of said systemic antibiotic(s) is not to exceed 21 days.
- When discharged from the hospital, participants will continue to take the study medication in the event he/she did not complete the intended course of the study medication while in the hospital.
- Participants will provide stool sample or rectal swabs for to assess their C.diff carrier status as well as any change in stool microbiome status, including VRE (vancomycin resistant Enterococcus)
- After completion of the intervention period, participants will be contacted via telephone to assess if they developed diarrhea or any untoward effects of study medication.
Read the detailed description
Protocol Synopsis
General: Enteral vancomycin has gained attention as a promising strategy for preventing healthcare facility-onset Clostridioides difficile infection (HCFO-CDI) in patients during systemic antibiotic exposure in certain high-risk populations. However, data remain scarce for its use as primary prophylaxis. Our study aims to fill this gap and evaluate whether enteral vancomycin prophylaxis can reduce the incidence of HCFO-CDI in critically ill patients along with other relevant clinical outcomes.
Study Population: Study subjects will include hospitalized subjects with significant risk factors for HCFO-CDI. Inclusion and exclusion criteria are as follows:
Inclusion criteria: Adult patients with at least 72 hours of hospitalization who are on a systemic antibiotic for at least 72 hours presenting with two additional risk factors for the development of HCFO-CDI.
Exclusion criteria: Subjects whose consent cannot be obtained, those with concurrent use of probiotics or metronidazole (except for empiric use), those with an expected course of antibiotic for more than 14 days, those with a prior history of CDI, etc.
Study Intervention: Study subjects will be randomized into two study arms - treatment versus placebo. Those in the treatment arm will receive vancomycin 125 mg solution daily for up to five days after the last dose of systemic antibiotic. Those in the placebo arm will receive a matching placebo solution. A rectal swab will be performed on all subjects prior to randomization and at study termination or discharge to assess C. difficile colonization and the possible development of vancomycin-resistant Enterococcus colonization.
Primary outcome: Incidence of HCFO-CDI, defined as symptoms of ≥ 3 loose stools or diarrhea (in the absence of laxatives or other non-CDI causes) in a 24-hour period in subjects with concurrent positive stool test for C. difficile (polymerase chain reaction [PCR] and stool toxin test) > 72 hours into hospitalization.
Enrollment period and sample size: First dose of enteral vancomycin or matching placebo will be administered within 72 hours of the first dose of systemic antibiotic. Study investigators will monitor the subjects for adherence and possible adverse events every 3 days until hospital discharge. We are planning 1:1 randomization of the study subjects in each group (placebo versus prophylaxis group). Utilizing a 2-sided α of 0.05 and 80% power, an estimated sample size is 176 (88 subject per arm). Sample size was determined by estimating a 0% incidence of HCFO-CDI in the prophylaxis arm and a 10% incidence of HCFO-CDI in the placebo arm based on historical and institutional data. We also anticipate a 20% drop out or attrition rate after randomization.
- Being tested
- Vancomycin 125mg, Placebo
- Keywords
- Clostridium difficle infection, primary prophylaxis, Vancomycin resistant enterocci infection
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin 125mgDrug
Vancomycin 125 mg orally daily
PlaceboDrug
Syrup solution used to mixed with Vancomycin will be used in equal volume to be the placebo comparator.
| Study group | Role | What they receive |
|---|---|---|
| Oral Vancomycin 125 mg (liquid) | Active comparator | Oral Vancomycin 125 mg (liquid) daily Receives: Drug: Vancomycin 125mg |
| Placebo oral (liquid) | Placebo comparator | Oral Placebo (liquid) daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence the rate of healthcare facility-onset Clostridioides dificile infection (CDFO-CFI).
Incidence of HCFO-CDI, defined as symptoms of ≥ 3 loose stools or diarrhea (in the absence of laxatives or other non-CDI causes) in a 24-hour period in subjects with concurrent positive stool test for C. difficile (polymerase chain reaction [PCR] and stool toxin test) > 72 hours into hospitalization.
Measured: up to 4 months
Secondary outcomes (6)
Incidence of Vancomycin Resistance Enterococcus (VRE) colonization in stool sample.
The rate of emergence of VRE will be tested as a part of safety outcome. All enrolled subject into the study will have stool/rectal swab tested for VRE at the time of enrollment and end of the study/early termination.
Measured: up to 30 days
Rate community onset healthcare facility-associated CDI.
Community-onset healthcare facility-associated CDI (CO-HFCA-CDI) will be assessed via telephonic surveys with the subjects 30- and 90-day post-discharge. CO-HFCA-CDI is defined as follows: subject's verbal confirmation of unexplained and new-onset ≥3 unformed stools in a 24-hour period since being discharged, subject seeking medical care for loose stools, and subject being diagnosed with CDI by a medical provider.
Measured: up to 90 days
Time to Clostridioides difficile infection in symptomatic patients
Time to Clostridioides difficile infection in symptomatic patients
Measured: up to 30 days
Clostridioides difficile colonization at discharge (PCR and toxin)
Clostridioides difficile colonization at discharge (PCR and toxin)
Measured: up to 30 days
Hospital length of stay (day)
Hospital length of stay (day)
Measured: up to 30 days
In-hospital Mortality
In-hospital mortality
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start21 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double Blind Placebo-controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riverside University Health System Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suman Thapamagar, Riverside University Health System Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221370
- Sponsor's protocol ID
- IRBNet #: 2114799-4
- Status last verified
- Nov 2025
- First submitted
- 8 Nov 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abt MC, McKenney PT, Pamer EG. Clostridium difficile colitis: pathogenesis and host defence. Nat Rev Microbiol. 2016 Oct;14(10):609-20. doi: 10.1038/nrmicro.2016.108. Epub 2016 Aug 30.
PubMed 27573580Bobo LD, Dubberke ER, Kollef M. Clostridium difficile in the ICU: the struggle continues. Chest. 2011 Dec;140(6):1643-1653. doi: 10.1378/chest.11-0556.
PubMed 22147824Rineh A, Kelso MJ, Vatansever F, Tegos GP, Hamblin MR. Clostridium difficile infection: molecular pathogenesis and novel therapeutics. Expert Rev Anti Infect Ther. 2014 Jan;12(1):131-50. doi: 10.1586/14787210.2014.866515.
PubMed 24410618Zhang S, Palazuelos-Munoz S, Balsells EM, Nair H, Chit A, Kyaw MH. Cost of hospital management of Clostridium difficile infection in United States-a meta-analysis and modelling study. BMC Infect Dis. 2016 Aug 25;16(1):447. doi: 10.1186/s12879-016-1786-6.
PubMed 27562241Vedantam G, Clark A, Chu M, McQuade R, Mallozzi M, Viswanathan VK. Clostridium difficile infection: toxins and non-toxin virulence factors, and their contributions to disease establishment and host response. Gut Microbes. 2012 Mar-Apr;3(2):121-34. doi: 10.4161/gmic.19399. Epub 2012 Mar 1.
PubMed 22555464Lemiech-Mirowska E, Michalkiewicz M, Sierocka A, Gaszynska E, Marczak M. The Hospital Environment as a Potential Source for Clostridioides difficile Transmission Based on Spore Detection Surveys Conducted at Paediatric Oncology and Gastroenterology Units. Int J Environ Res Public Health. 2023 Jan 15;20(2):1590. doi: 10.3390/ijerph20021590.
PubMed 36674344Kochan TJ, Foley MH, Shoshiev MS, Somers MJ, Carlson PE, Hanna PC. Updates to Clostridium difficile Spore Germination. J Bacteriol. 2018 Jul 25;200(16):e00218-18. doi: 10.1128/JB.00218-18. Print 2018 Aug 15.
PubMed 29760211Gil F, Lagos-Moraga S, Calderon-Romero P, Pizarro-Guajardo M, Paredes-Sabja D. Updates on Clostridium difficile spore biology. Anaerobe. 2017 Jun;45:3-9. doi: 10.1016/j.anaerobe.2017.02.018. Epub 2017 Feb 22.
PubMed 28254263Paredes-Sabja D, Shen A, Sorg JA. Clostridium difficile spore biology: sporulation, germination, and spore structural proteins. Trends Microbiol. 2014 Jul;22(7):406-16. doi: 10.1016/j.tim.2014.04.003. Epub 2014 May 7.
PubMed 24814671Martinez-Melendez A, Cruz-Lopez F, Morfin-Otero R, Maldonado-Garza HJ, Garza-Gonzalez E. An Update on Clostridioides difficile Binary Toxin. Toxins (Basel). 2022 Apr 27;14(5):305. doi: 10.3390/toxins14050305.
PubMed 35622552Johnson SW, Brown SV, Priest DH. Effectiveness of Oral Vancomycin for Prevention of Healthcare Facility-Onset Clostridioides difficile Infection in Targeted Patients During Systemic Antibiotic Exposure. Clin Infect Dis. 2020 Aug 22;71(5):1133-1139. doi: 10.1093/cid/ciz966.
PubMed 31560051Papic N, Maric LS, Vince A. Efficacy of oral vancomycin in primary prevention of Clostridium Difficile infection in elderly patients treated with systemic antibiotic therapy. Infect Dis (Lond). 2018 Jun;50(6):483-486. doi: 10.1080/23744235.2018.1425551. Epub 2018 Jan 11. No abstract available.
PubMed 29323607DailyMed - FIRVANQ- vancomycin hydrochloride kit. Accessed September 7, 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5aca5508-b577-446c-9980-ab4c7582b4b9
Fishbein SRS, Hink T, Reske KA, Cass C, Struttmann E, Iqbal ZH, Seiler S, Kwon JH, Burnham CA, Dantas G, Dubberke ER. Randomized Controlled Trial of Oral Vancomycin Treatment in Clostridioides difficile-Colonized Patients. mSphere. 2021 Jan 13;6(1):e00936-20. doi: 10.1128/mSphere.00936-20.
PubMed 33441409Ganetsky A, Han JH, Hughes ME, Babushok DV, Frey NV, Gill SI, Hexner EO, Loren AW, Luger SM, Mangan JK, Martin ME, Smith J, Freyer CW, Gilmar C, Schuster M, Stadtmauer EA, Porter DL. Oral Vancomycin Prophylaxis Is Highly Effective in Preventing Clostridium difficile Infection in Allogeneic Hematopoietic Cell Transplant Recipients. Clin Infect Dis. 2019 May 30;68(12):2003-2009. doi: 10.1093/cid/ciy822.
PubMed 30256954
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07221370
- Acronym / sponsor ID
- IRBNet #: 2114799-4
- Keywords
- Clostridium difficle infection, primary prophylaxis, Vancomycin resistant enterocci infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Riverside University Health System Medical CenterUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine if oral vancomycin can prevent C.diff infection in adults who are critically ill and are at high risk of C.diff infection due to their medical conditions and being in the hospital. It will also help us learn about the safety of the drug in this setting. The main questions the trial aims to answer are:
- Does oral vancomycin lower the rate of C.diff infection in high-risk patients?
- Does C.diff carrier status change the C.diff infection rate as well as clearance of carrier status when vancomycin is used as primary prophylaxis? Researchers will compare the oral, active drug vancomycin to a placebo (a look-alike substance that contains no drug) to determine if vancomycin works to prevent C.diff infection in the hospital.
Participants will:
- Take oral vancomycin or a placebo while they receive systemic antibiotic(s) for up to five days after the last dose of said systemic antibiotic(s). The treatment of said systemic antibiotic(s) is not to exceed 21 days.
- When discharged from the hospital, participants will continue to take the study medication in the event he/she did not complete the intended course of the study medication while in the hospital.
- Participants will provide stool sample or rectal swabs for to assess their C.diff carrier status as well as any change in stool microbiome status, including VRE (vancomycin resistant Enterococcus)
- After completion of the intervention period, participants will be contacted via telephone to assess if they developed diarrhea or any untoward effects of study medication.
Detailed description
Protocol Synopsis
General: Enteral vancomycin has gained attention as a promising strategy for preventing healthcare facility-onset Clostridioides difficile infection (HCFO-CDI) in patients during systemic antibiotic exposure in certain high-risk populations. However, data remain scarce for its use as primary prophylaxis. Our study aims to fill this gap and evaluate whether enteral vancomycin prophylaxis can reduce the incidence of HCFO-CDI in critically ill patients along with other relevant clinical outcomes.
Study Population: Study subjects will include hospitalized subjects with significant risk factors for HCFO-CDI. Inclusion and exclusion criteria are as follows:
Inclusion criteria: Adult patients with at least 72 hours of hospitalization who are on a systemic antibiotic for at least 72 hours presenting with two additional risk factors for the development of HCFO-CDI.
Exclusion criteria: Subjects whose consent cannot be obtained, those with concurrent use of probiotics or metronidazole (except for empiric use), those with an expected course of antibiotic for more than 14 days, those with a prior history of CDI, etc.
Study Intervention: Study subjects will be randomized into two study arms - treatment versus placebo. Those in the treatment arm will receive vancomycin 125 mg solution daily for up to five days after the last dose of systemic antibiotic. Those in the placebo arm will receive a matching placebo solution. A rectal swab will be performed on all subjects prior to randomization and at study termination or discharge to assess C. difficile colonization and the possible development of vancomycin-resistant Enterococcus colonization.
Primary outcome: Incidence of HCFO-CDI, defined as symptoms of ≥ 3 loose stools or diarrhea (in the absence of laxatives or other non-CDI causes) in a 24-hour period in subjects with concurrent positive stool test for C. difficile (polymerase chain reaction [PCR] and stool toxin test) > 72 hours into hospitalization.
Enrollment period and sample size: First dose of enteral vancomycin or matching placebo will be administered within 72 hours of the first dose of systemic antibiotic. Study investigators will monitor the subjects for adherence and possible adverse events every 3 days until hospital discharge. We are planning 1:1 randomization of the study subjects in each group (placebo versus prophylaxis group). Utilizing a 2-sided α of 0.05 and 80% power, an estimated sample size is 176 (88 subject per arm). Sample size was determined by estimating a 0% incidence of HCFO-CDI in the prophylaxis arm and a 10% incidence of HCFO-CDI in the placebo arm based on historical and institutional data. We also anticipate a 20% drop out or attrition rate after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Double Blind Placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Oral Vancomycin 125 mg (liquid) | Active comparator | Drug: Vancomycin 125mgOral Vancomycin 125 mg (liquid) daily |
| Placebo oral (liquid) | Placebo comparator | Drug: PlaceboOral Placebo (liquid) daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Must meet all 3 criteria:
- And must meet 2 additional of the following high-risk criteria
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding women
- Currently incarcerated individuals
- Individual or legal representative whose informed consent cannot be obtained
- Subject not expected to survive the ICU stay or subject likely to be considered for palliative or hospice care
- Receiving concurrent treatment with metronidazole for any indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin 125mgVancomycin 125 mg orally daily | Drug | Oral Vancomycin 125 mg (liquid) |
| PlaceboSyrup solution used to mixed with Vancomycin will be used in equal volume to be the placebo comparator. | Drug | Placebo oral (liquid) |
Primary outcome
Incidence the rate of healthcare facility-onset Clostridioides dificile infection (CDFO-CFI).
Time frame: up to 4 months
Incidence of HCFO-CDI, defined as symptoms of ≥ 3 loose stools or diarrhea (in the absence of laxatives or other non-CDI causes) in a 24-hour period in subjects with concurrent positive stool test for C. difficile (polymerase chain reaction [PCR] and stool toxin test) > 72 hours into hospitalization.
6 secondary outcomes
Incidence of Vancomycin Resistance Enterococcus (VRE) colonization in stool sample.
Time frame: up to 30 days
Rate community onset healthcare facility-associated CDI.
Time frame: up to 90 days
Time to Clostridioides difficile infection in symptomatic patients
Time frame: up to 30 days
Clostridioides difficile colonization at discharge (PCR and toxin)
Time frame: up to 30 days
Hospital length of stay (day)
Time frame: up to 30 days
In-hospital Mortality
Time frame: up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Background: PubMed 27573580Abt MC, McKenney PT, Pamer EG. Clostridium difficile colitis: pathogenesis and host defence. Nat Rev Microbiol. 2016 Oct;14(10):609-20. doi: 10.1038/nrmicro.2016.108. Epub 2016 Aug 30.
- Background: PubMed 22147824Bobo LD, Dubberke ER, Kollef M. Clostridium difficile in the ICU: the struggle continues. Chest. 2011 Dec;140(6):1643-1653. doi: 10.1378/chest.11-0556.
- Background: PubMed 24410618Rineh A, Kelso MJ, Vatansever F, Tegos GP, Hamblin MR. Clostridium difficile infection: molecular pathogenesis and novel therapeutics. Expert Rev Anti Infect Ther. 2014 Jan;12(1):131-50. doi: 10.1586/14787210.2014.866515.
- Background: PubMed 27562241Zhang S, Palazuelos-Munoz S, Balsells EM, Nair H, Chit A, Kyaw MH. Cost of hospital management of Clostridium difficile infection in United States-a meta-analysis and modelling study. BMC Infect Dis. 2016 Aug 25;16(1):447. doi: 10.1186/s12879-016-1786-6.
- Background: PubMed 22555464Vedantam G, Clark A, Chu M, McQuade R, Mallozzi M, Viswanathan VK. Clostridium difficile infection: toxins and non-toxin virulence factors, and their contributions to disease establishment and host response. Gut Microbes. 2012 Mar-Apr;3(2):121-34. doi: 10.4161/gmic.19399. Epub 2012 Mar 1.
- Background: PubMed 36674344Lemiech-Mirowska E, Michalkiewicz M, Sierocka A, Gaszynska E, Marczak M. The Hospital Environment as a Potential Source for Clostridioides difficile Transmission Based on Spore Detection Surveys Conducted at Paediatric Oncology and Gastroenterology Units. Int J Environ Res Public Health. 2023 Jan 15;20(2):1590. doi: 10.3390/ijerph20021590.
- Background: PubMed 29760211Kochan TJ, Foley MH, Shoshiev MS, Somers MJ, Carlson PE, Hanna PC. Updates to Clostridium difficile Spore Germination. J Bacteriol. 2018 Jul 25;200(16):e00218-18. doi: 10.1128/JB.00218-18. Print 2018 Aug 15.
- Background: PubMed 28254263Gil F, Lagos-Moraga S, Calderon-Romero P, Pizarro-Guajardo M, Paredes-Sabja D. Updates on Clostridium difficile spore biology. Anaerobe. 2017 Jun;45:3-9. doi: 10.1016/j.anaerobe.2017.02.018. Epub 2017 Feb 22.
- Background: PubMed 24814671Paredes-Sabja D, Shen A, Sorg JA. Clostridium difficile spore biology: sporulation, germination, and spore structural proteins. Trends Microbiol. 2014 Jul;22(7):406-16. doi: 10.1016/j.tim.2014.04.003. Epub 2014 May 7.
- Background: PubMed 35622552Martinez-Melendez A, Cruz-Lopez F, Morfin-Otero R, Maldonado-Garza HJ, Garza-Gonzalez E. An Update on Clostridioides difficile Binary Toxin. Toxins (Basel). 2022 Apr 27;14(5):305. doi: 10.3390/toxins14050305.
- Background: PubMed 31560051Johnson SW, Brown SV, Priest DH. Effectiveness of Oral Vancomycin for Prevention of Healthcare Facility-Onset Clostridioides difficile Infection in Targeted Patients During Systemic Antibiotic Exposure. Clin Infect Dis. 2020 Aug 22;71(5):1133-1139. doi: 10.1093/cid/ciz966.
- Background: PubMed 29323607Papic N, Maric LS, Vince A. Efficacy of oral vancomycin in primary prevention of Clostridium Difficile infection in elderly patients treated with systemic antibiotic therapy. Infect Dis (Lond). 2018 Jun;50(6):483-486. doi: 10.1080/23744235.2018.1425551. Epub 2018 Jan 11. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vancomycin 125mg in people with Clostridium Difficile Infection and Vancomycin Resistant Enterococci Infection, run by Riverside University Health System Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suman Thapamagar, MD (9514864000, suman.thapamagar@ruhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence the rate of healthcare facility-onset Clostridioides dificile infection (CDFO-CFI). (time frame: up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07221370, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.