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Should cancer patients get antibiotics for a dubious c. diff test? small trial seeks answers

NCT ID NCT03030248

Disease control Sponsor: Medical College of Wisconsin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving the antibiotic vancomycin helps cancer patients who have diarrhea and a positive screening test for C. difficile but a negative toxin test. Only 9 patients were enrolled, far fewer than planned. Researchers measured changes in C. difficile levels in stool and other gut bacteria over 90 days. The results are too limited to draw firm conclusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vancomycin oral capsules
What this could lead to
If it works, this could help doctors decide whether to treat certain C. diff infections in cancer patients with antibiotics, reducing unnecessary use.
What could go wrong
This is a very small, early-phase study with only 9 participants, so results may not be reliable or apply to broader populations. The infection type studied is controversial and may not need treatment at all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

9 people

The number who actually took part.

Started

Jun 2018

Finished

Jun 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients admitted to the hematology oncology inpatient units at Froedtert Memorial Lutheran Hospital * New onset of diarrhea during hospitalization * C. difficile clinical testing showing NAAT positive EIA negative results Exclusion Criteria: * Being unable to consent for self * Inability to take enteral medications * Unwillingness to enroll in study * Patient has a documented allergy to vancomycin * Patient has a documented life expectancy shorter than treatment course (14 days) * Patient is unwilling or unable to provide stool samples in the outpatient setting after discharge * Diagnosis of C. difficile colitis \[NAAT (+) and toxin EIA (+) within 3 months of enrollment). * New onset of abdominal distention within 24 hours prior to the onset of diarrhea during index admission * Presence of toxic megacolon * Presence of clinical sepsis. Sepsis will be defined as a Sequential \[Sepsis-related\] Organ Failure Assessment (SOFA) score of 2 points or more as per 2016 definitions * Pregnancy or lactating

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis Clostridium infectious disease hematologic disorder neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bone marrow transplant Clostridium difficile infection Hematologic diseases Oncologic disorders

Contacts and locations

Locations

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

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