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Antibiotics before melanoma surgery: gut bacteria under the microscope

NCT ID NCT04875728

Knowledge-focused Sponsor: M.D. Anderson Cancer Center 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how a single dose of antibiotics given before melanoma surgery changes the bacteria in your gut. Researchers want to see if these changes affect how well the body responds to surgery and cancer treatment. The study involves 20 adults with early-stage melanoma who are scheduled for surgery.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Feb 2027

An estimate. End dates often move.

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: * Adult subjects with early stage melanoma (stage I-II) * Patients must be undergoing wide local excision +/- sentinel lymph node biopsy * Patients must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Exclusion Criteria: * Use of antibiotics within the three months prior to surgery * Allergy, sensitivity or anaphylaxis to beta-lactam or cephalosporin antibiotics * Presence of an infection at the time of surgery * Increased risk of infection due to a co-existing medical condition as determined by the surgical team or principal investigator (PI) * Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration * American Society of Anesthesiologists (ASA) grade \> IV * Refusal to participate in the study * Patients who are pregnant will not be included in this study

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma

As listed by the trial registrant

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

Clinical stage I cutaneous melanoma ajcc V8 Clinical stage IA cutaneous melanoma ajcc V8 Clinical stage IB cutaneous melanoma ajcc V8 Clinical stage II cutaneous melanoma ajcc V8 Clinical stage IIA cutaneous melanoma ajcc V8 Clinical stage IIB cutaneous melanoma ajcc V8 Clinical stage IIC cutaneous melanoma ajcc V8 Pathologic stage I cutaneous melanoma ajcc V8 Pathologic stage IA cutaneous melanoma ajcc V8 Pathologic stage IB cutaneous melanoma ajcc V8 Pathologic stage II cutaneous melanoma ajcc V8 Pathologic stage IIA cutaneous melanoma ajcc V8 Pathologic stage IIB cutaneous melanoma ajcc V8 Pathologic stage IIC cutaneous melanoma ajcc V8

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.