Clostridium Difficile InfectionPhase 4NCT03466502
Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics
A Phase 4 study testing Oral Vancomycin in people with Clostridium Difficile Infection, run by University of Nevada, Reno at 1 site in United States.
Trial summary
This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Oral Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2018to 17 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Age ≥18 years
- Previous CDI diagnosis
- Current admission with a suspected or a confirmed bacterial infection requiring antibiotics
Who cannot join
- Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome)
- Previous adverse reactions to oral vancomycin
- Requiring metronidazole during hospitalization
- Known pregnancy
- Expected survival <72 hours
- Patients receiving antibiotics only for surgical prophylaxis
- Patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Prophylactic Oral Vancomycin in Preventing Recurrent Clostridium Difficile Infection in Hospitalized Patients Requiring Antibiotics
This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.
Read the detailed description
This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Oral Vancomycin
- Keywords
- vancomycin, Clostridium difficile, Clostridium difficile infection, Recurrent Clostridium difficile 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.
Oral VancomycinDrug
Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence
| Study group | Role | What they receive |
|---|---|---|
| No oral vancomycin | No intervention | Not described |
| Oral vancomycin 125 mg twice daily | Experimental | Not described Receives: Drug: Oral Vancomycin |
| Oral vancomycin 125 mg daily | Experimental | Not described Receives: Drug: Oral Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Clostridium difficile infection
Diarrheal illness, with at least 3 episodes of watery diarrhea over a 24 hour period and a positive toxin analysis or a positive PCR for Cdiff
Measured: During hospitalization or the 12 weeks after therapy
Secondary outcomes (6)
Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics
- Low inducers: aminoglycosides, fosfomycin, glycopeptides, daptomycin, nitrofurantoin, linezolid, polymyxins, rifamycins, antifolates and/or sulfonamides, tetracyclines, tigecycline
- Moderate inducers: penicillins, 1st generation cephalosporins, macrolides, azithromycin, streptogramins
- High inducers: carbapenems, 2nd and greater generation cephalosporins, fluoroquinolones, clindamycin
Measured: During hospitalization or the 12 weeks after therapy
Time between recurrent CDI and the last C diff infection
Measured: During hospitalization or the 12 weeks after therapy
Rate of recurrence of CDI in immunocompromised patients
HIV, Organ Transplantation, Current Immunosuppressive therapy, Hypogammaglobulinemia or steroids dose more than prednisone 20mg/day for 3 weeks
Measured: During hospitalization or the 12 weeks after therapy
Rate of recurrence of CDI in patients with a history of the NAP-1 strain
Measured: During hospitalization or the 12 weeks after therapy
Rate of reported adverse events
Measured: During hospitalization or the 12 weeks after therapy
Mortality rate
Measured: During hospitalization or the 12 weeks after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start8 Mar 2018
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Collaborators
- Renown Regional Medical Center
- Responsible party
- Principal investigator, Lauren Zion, PharmD, University of Nevada, Reno
- Investigators
- Lauren Zion, PharmD, Principal investigator, Renown Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466502
- Sponsor's protocol ID
- 1129396
- Status last verified
- Nov 2023
- First submitted
- 8 Mar 2018
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prophylactic Oral Vancomycin in Preventing Recurrent Clostridium Difficile Infection in Hospitalized Patients Requiring Antibiotics
- ClinicalTrials.gov ID
- NCT03466502
- Acronym / sponsor ID
- 1129396
- Conditions
- Clostridium Difficile Infection
- Keywords
- vancomycin, Clostridium difficile, Clostridium difficile infection, Recurrent Clostridium difficile infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Collaborators
- Renown Regional Medical Center
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 15 Mar 2018 (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.
This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.
Detailed description
This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No oral vancomycin | No intervention | – |
| Oral vancomycin 125 mg twice daily | Experimental | Drug: Oral Vancomycin |
| Oral vancomycin 125 mg daily | Experimental | Drug: Oral Vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Previous CDI diagnosis
- Current admission with a suspected or a confirmed bacterial infection requiring antibiotics
Key exclusion criteria (7 listed)
- Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome)
- Previous adverse reactions to oral vancomycin
- Requiring metronidazole during hospitalization
- Known pregnancy
- Expected survival <72 hours
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 |
|---|---|---|
| Oral VancomycinOral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence | Drug | Oral vancomycin 125 mg daily, Oral vancomycin 125 mg twice daily |
Primary outcome
Recurrent Clostridium difficile infection
Time frame: During hospitalization or the 12 weeks after therapy
Diarrheal illness, with at least 3 episodes of watery diarrhea over a 24 hour period and a positive toxin analysis or a positive PCR for Cdiff
6 secondary outcomes
Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics
Time frame: During hospitalization or the 12 weeks after therapy
Time between recurrent CDI and the last C diff infection
Time frame: During hospitalization or the 12 weeks after therapy
Rate of recurrence of CDI in immunocompromised patients
Time frame: During hospitalization or the 12 weeks after therapy
Rate of recurrence of CDI in patients with a history of the NAP-1 strain
Time frame: During hospitalization or the 12 weeks after therapy
Rate of reported adverse events
Time frame: During hospitalization or the 12 weeks after therapy
Mortality rate
Time frame: During hospitalization or the 12 weeks after therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lauren Zion, PharmD principal investigator
Renown Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Vancomycin in people with Clostridium Difficile Infection, run by University of Nevada, Reno 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 28 Nov 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Clostridium difficile infection (time frame: During hospitalization or the 12 weeks after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.