ClinicalTrials.gg
CompletedNCT03466502Updated Nov 28, 2023

Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

A Phase 4 interventional study of Oral Vancomycin in Clostridium Difficile Infection, sponsored by University of Nevada, Reno. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by University of Nevada, Reno · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Feb 2022, 4 years 8 months ago, and no results have been posted to the registry.

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Phase
Phase 4
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 20 studies testing vancomycin in Clostridium Infections — 4 open to participants now, 4 under way, 2 of them phase 3. Vancomycin · Clostridium Infections.

Enrollment
7th of 20
104 · median 63
Started
2018
with 2 others
Phase 4
10 of 20
1 open now
Registered
10th of 20
by date

Among the 20 studies testing vancomycin in Clostridium Infections, this one is the 7th largest by enrollment, is one of 3 that started in 2018, is one of 10 in phase 4, and was the 10th registered.

Clostridium Infections

251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.

Browse Clostridium Infections studies →

Open to participants now

4 of the 20 studies testing vancomycin in Clostridium Infections are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

About vancomycin

Vancomycin: first FDA approval 1964 (VANCOCIN HYDROCHLORIDE). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 36 Clostridium Infections studies recruiting now, 22 (61%) set no upper age limit and 8 (22%) stop at 75 or younger; 9 take children under 18; 3 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies testing vancomycin in Clostridium Infections, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Clostridium Difficile Infection

Keywords

  • vancomycin
  • Clostridium difficile
  • Clostridium difficile infection
  • Recurrent Clostridium difficile infection
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years
  2. Previous CDI diagnosis
  3. Current admission with a suspected or a confirmed bacterial infection requiring antibiotics

Exclusion criteria

Exclusion Criteria:

  1. Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome)
  2. Previous adverse reactions to oral vancomycin
  3. Requiring metronidazole during hospitalization
  4. Known pregnancy
  5. Expected survival \<72 hours
  6. Patients receiving antibiotics only for surgical prophylaxis
  7. Patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • No intervention
    No oral vancomycin
  • Experimental
    Oral vancomycin 125 mg twice daily

    Drug: Oral Vancomycin

  • Experimental
    Oral vancomycin 125 mg daily

    Drug: Oral Vancomycin

Interventions

  • Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: During hospitalization or the 12 weeks after therapy

Secondary outcomes

  1. 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

    Time frame: During hospitalization or the 12 weeks after therapy

  2. Time between recurrent CDI and the last C diff infection

    Time frame: During hospitalization or the 12 weeks after therapy

  3. 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

    Time frame: During hospitalization or the 12 weeks after therapy

  4. 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

  5. Rate of reported adverse events

    Time frame: During hospitalization or the 12 weeks after therapy

  6. Mortality rate

    Time frame: During hospitalization or the 12 weeks after therapy

07

Study locations

1 site
  • Renown Regional Medical Center
    Reno, Nevada 89502, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Feb 2022, 47 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2018
First posted
Mar 15, 2018
StartActual
Mar 8, 2018
Primary completionActual
Feb 17, 2022
CompletionActual
Feb 17, 2022
Last update
Nov 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03466502
Lead sponsor
University of Nevada, Reno
Collaborators
Renown Regional Medical Center
Responsible party
Lauren Zion, PharmD (Pharmacist, University of Nevada, Reno) — Principal investigator
First posted
Mar 15, 2018
Start date
Mar 8, 2018
Primary completion
Feb 17, 2022
Completion
Feb 17, 2022
Last update
Nov 28, 2023

Study contacts

Lauren Zion, PharmD
principal investigator · Renown Regional Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vancomycin

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