A Phase 4 interventional study of Oral Vancomycin and Placebo in Clostridium Difficile Infection and Diarrhea, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-26.
Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Other
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Among 20 studies testing vancomycin in Clostridium Infections — 4 open to participants now, 4 under way, 2 of them phase 3. Vancomycin · Clostridium Infections.
Among the 20 studies testing vancomycin in Clostridium Infections, this one is the 16th largest by enrollment, is one of 3 that started in 2017, is one of 10 in phase 4, and was the 8th registered.
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
Browse Clostridium Infections studies →4 of the 20 studies testing vancomycin in Clostridium Infections are open now, in 2 countries. Recruiting first, the newest first:
Riverside University Health System Medical Center · Sites in United States
Ages 18+
Leiden University Medical Center · Sites in Netherlands
Ages 18–45 · Healthy volunteers
Brigham and Women's Hospital · Sites in United States
Ages 18+
Assistance Publique - Hôpitaux de Paris
Ages 15+
By country, each count listing its studies:
Vancomycin: first FDA approval 1964 (VANCOCIN HYDROCHLORIDE). What it is approved for, and how studies give it, is on its page →
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.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 5 · Phase 3 5 · Phase 4 10
First in 2012; this study’s year is marked. 3 started in 2017.
This study's enrollment of 15 is below the median of 64 across 185 interventional studies indexed under Clostridium Infections.
Median enrollment 63 across the 20 interventional studies. Of the 14 that completed or were terminated, 8 (57%) have results posted.
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None of the 20 has an industry lead sponsor. The 10 most frequent:
Washington University School of Medicine is the lead sponsor of 1,805 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Washington University School of Medicine has 2 studies filed under Clostridium Infections — fewer than ten, so there is no comparison to draw.
1 of the studies testing vancomycin in Clostridium Infections that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07221370Phase 3Riverside University Health System Medical CenterEnteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients | 2026-12-31 |
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Among the 20 studies testing vancomycin in Clostridium Infections, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid amplification test (NAAT) positive and enzyme immunoassay (EIA) negative for C. difficile.
Currently, healthcare facilities use a wide variety of tests and strategies for identifying patients with CDI; both EIA and NAAT are widely used. There is no clear gold standard for identifying CDI. At WUSM and BJH, patients are only treated for CDI if they have a positive EIA. However, at many other healthcare facilities, the standard of care is to treat for CDI if the patient is NAAT positive. Some patients who are NAAT-positive may not have true CDI; while this treatment is standard of care at many facilities, the risk and benefits of treating these patients for CDI is unknown.
We propose to perform a double blinded, randomized controlled non-inferiority trial of antimicrobial of patients who are EIA negative, NAAT positive to determine the risks and benefits of CDI treatment in this population.
Study Purpose:
The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid amplification test (NAAT) positive and enzyme immunoassay (EIA) negative for C. difficile.
Background:
Clostridium difficile infection (CDI) is the most common cause of healthcare-associated diarrhea. There is no gold standard diagnostic test for (CDI). Commercially available assays detect C. difficile or its toxins in stool. Nucleic acid amplification tests (NAAT) are much more sensitive than toxin enzyme immunoassays (EIA). However, clinical correlation is needed to determine who has CDI. Most US clinical microbiology laboratories have adopted NAATs for C. difficile under the presumption the enhanced analytical sensitivity was beneficial. Although some patients with NAAT-positive/toxin-negative stool have CDI and a false-negative toxin EIA, subsequent studies indicate most patients with NAAT-positive / toxin-negative stool do not have CDI. Rather, they are asymptomatic C. difficile carriers who have diarrhea for other reasons. Most of these studies also have limitations and considerable controversy remains for whether NAATs or toxin EIAs should be used when CDI is suspected.
Treatment of asymptomatic C. difficile carriers is not beneficial, and may result in harm. At hospitals that utilize NAATs, most patients with NAAT-positive / toxin-negative stool receive treatment for CDI. The most common treatments for CDI, metronidazole and oral vancomycin, are highly disruptive of the intestinal microbiome. These antimicrobials create selective pressures that promote the acquisition and proliferation of antimicrobial resistance and multidrug resistant organisms (MDRO), including public health threats such as MDRO Enterobacteriaceae like carbapenem-resistant Enterobacteriaceae (CRE) and extended-spectrum beta-lactamase (ESBL) producing organisms, vancomycin-resistant Enterococcus (VRE), and the latest emerging threat Candida auris. This leads to MDRO infections and MDRO spread to others. Paradoxically, unnecessary treatment for CDI may increase risk for CDI once treatment is stopped contributing to CDI-related adverse events and C. difficile spread to others. Unnecessary CDI treatment potentially harms both that patient and other people. Whether the benefit of treating patients with NAAT-positive/toxin-negative stool that are missed cases of CDI outweighs the risk of treating patients with NAAT-positive/toxin-negative stool that are asymptomatic C. difficile carriers remains unknown.
This study is a double-blinded randomized controlled trial of CDI treatment for patients with NAAT-positive / toxin-negative stool. Such a trial is necessary to understand the risk-benefit of treating these patients for CDI. Patients with NAAT-positive / toxin-negative stool who consent to participate will be randomized to 10 days of oral vancomycin or placebo. Stool and environmental specimens will be obtained at regular time points and interrogated with culturomic and metagenomic methods. Patients will be followed until eight weeks after discontinuation of study drug. These data and specimens will be used to determine the impact of oral vancomycin versus placebo on the microbiome, C. difficile and MDRO colonization, environmental contamination, duration of diarrhea, CDI-related adverse events, and death.
Specific aims and hypotheses:
Specific Aim 1: Determine if there are differences in microbiome disruption and acquisition / persistence of C. difficile and other MDRO carriage in stool among patients with NAAT-positive / toxin-negative stool who are randomized to a 10-day course of oral vancomycin versus placebo.
Hypotheses: Study participants who receive oral vancomycin will have greater disruption of the taxonomic and functional metabolic profiles of the fecal microbiome, increases in antimicrobial resistance genes, acquire more MDRO, and will have greater persistence and abundance of MDRO in stool compared to participants who receive placebo. Participants who receive oral vancomycin will not have detectable C. difficile in stool after completion of study drug, but will be more likely to have C. difficile in stool at week 8 after completion of study drug compared to participants who receive placebo.
Specific Aim 2: Determine if there are differences in C. difficile and other MDRO environmental contamination between treatment groups.
Hypothesis: Study participants who receive oral vancomycin will have less environmental C. difficile contamination but more MDRO contamination compared to participants who receive placebo while receiving study drug. After study drug is completed, those who receive oral vancomycin will have more environmental contamination due to both C. difficile and other MDROs.
Specific Aim 3: Determine if there are differences in CDI-related outcomes between groups.
Hypothesis: There will be no difference in time to resolution of diarrhea or CDI-related outcomes between treatment groups.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
125mg of oral vancomycin four times per day
Drug: Oral Vancomycin · Device: Toxin enzyme immunoassay · Device: Nuceleic acid amplification test
Placebo four times per day
Drug: Placebo · Device: Toxin enzyme immunoassay · Device: Nuceleic acid amplification test
Oral vancomycin 125mg 4 times per day
Also known as: Vancocin
Sugar liquid manufactured to mimic oral vancomycin 125mg
EIA assay: Wampole/Tech Lab Tox A/B II
NAAT: Xpert C. difficile, Cepheid
Number of Participants With Detectable C. Difficile
Stool specimens will be examined via culture and metagenomic analyses for the presence of detectable C. difficile. Presence will be defined as presence of culturable C. difficile in stool any time after collection of enrollment stool samples.
Time frame: Through 8 weeks after completion of study drug
Number of Participants With Detectable Environmental Contamination
Swabs from participants' home and hospital environments will be examined via culture and metagenomic analyses for the presence and/or persistence of C. difficile and other multidrug resistant organisms.
Time frame: Through 8 weeks after completion of study drug
Duration of Diarrhea in Study Participants as Defined by Daily Symptoms and Questionnaire Using the Bristol Stool Chart
Duration of diarrhea will be compared between groups. Duration of diarrhea will be assessed daily during study drug using a questionnaire and the Bristol Stool Chart. The Bristol Stool Chart measures stool consistency. Diarrhea will be defined as Bristol Stool Chart types 5-7.
Time frame: Through 8 weeks after completion of study drug
Presence of Other Multidrug Resistant Organisms in the Gut Microbiome of Study Participants
Stool specimens will be examined via culture and metagenomic analyses for the presence of multidrug resistant organisms before and after study drug.
Time frame: Through 8 weeks after completion of the study drug
| Milestone | Oral Vancomycin | Placebo |
|---|---|---|
| Started | 8 | 7 |
| Completed | 7 | 4 |
| Not completed | 1 | 3 |
Stool specimens will be examined via culture and metagenomic analyses for the presence of detectable C. difficile. Presence will be defined as presence of culturable C. difficile in stool any time after collection of enrollment stool samples.
| Participants | Oral Vancomycin | Placebo |
|---|---|---|
| Number of Participants With Detectable C. Difficile | 5 | 4 |
Swabs from participants' home and hospital environments will be examined via culture and metagenomic analyses for the presence and/or persistence of C. difficile and other multidrug resistant organisms.
| Participants | Oral Vancomycin | Placebo |
|---|---|---|
| Number of Participants With Detectable Environmental Contamination | 5 | 4 |
Duration of diarrhea will be compared between groups. Duration of diarrhea will be assessed daily during study drug using a questionnaire and the Bristol Stool Chart. The Bristol Stool Chart measures stool consistency. Diarrhea will be defined as Bristol Stool Chart types 5-7.
| Days | Oral Vancomycin | Placebo |
|---|---|---|
| Duration of Diarrhea in Study Participants as Defined by Daily Symptoms and Questionnaire Using the Bristol Stool Chart | 2 (2 to 13) | 4 (3 to 11) |
Stool specimens will be examined via culture and metagenomic analyses for the presence of multidrug resistant organisms before and after study drug.
| Participants | Oral Vancomycin | Placebo |
|---|---|---|
| Presence of Other Multidrug Resistant Organisms in the Gut Microbiome of Study Participants | 6 | 4 |
Collected over Adverse events were collected through 8 weeks after completion of the study drug.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Vancomycin | 0/8 (0%) | 2/8 (25%) | 3/8 (37.5%) |
| Placebo | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Event | Oral Vancomycin | Placebo |
|---|---|---|
| Volume overloadEndocrine disorders | 1/8 | 0/7 |
| HypoxemiaVascular disorders | 1/8 | 0/7 |
| Event | Oral Vancomycin | Placebo |
|---|---|---|
| Abdominal painGastrointestinal disorders | 2/8 | 0/7 |
| Headache, vertigo, nausea/vomitingGeneral disorders | 0/8 | 1/7 |
| C. difficile EIA positive stool sampleGastrointestinal disorders | 0/8 | 1/7 |
| Syncope, altered mental statusGeneral disorders | 1/8 | 0/7 |
| Age, Continuous(years) | Oral Vancomycin | Placebo | Total |
|---|---|---|---|
| Median | 66 (37 to 81) | 64 (48 to 77) | 65 (37 to 81) |
| Sex: Female, Male(Participants) | Oral Vancomycin | Placebo | Total |
|---|---|---|---|
| Female | 4 | 6 | 10 |
| Male | 4 | 1 | 5 |
| Race/Ethnicity, Customized(Participants) | Oral Vancomycin | Placebo | Total |
|---|---|---|---|
| Non-white race | 1 | 1 | 2 |
| White race | 7 | 6 | 13 |
| Region of Enrollment(participants) | Oral Vancomycin | Placebo | Total |
|---|---|---|---|
| United States | 8 | 7 | 15 |
| Receiving antibiotics at enrollment(Participants) | Oral Vancomycin | Placebo | Total |
|---|---|---|---|
| Count of participants | 3 | 2 | 5 |
Ran from Dec 2017 to primary completion in Jan 2021, 37 months.
Results were first posted in Jul 2021, 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vancomycin
Washington University School of Medicine →