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The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma

NCT04875728 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-20

No results posted yet for this study

Summary

This phase I trial investigates the impact of cefazolin before surgery on the microbiome in patients with stage I-II melanoma. Antibiotics, such as cefazolin, given at the time of surgery may cause a significant change in the microbes (like bacteria and viruses) found in the stomach and intestines. This trial may help researchers learn if any changes in microbes affect the body's ability to respond to surgery and cancer.

Conditions

  • 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

Interventions

DRUG

Cefazolin

Given IV

PROCEDURE

Resection

Undergo standard of care surgical resection

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Emily Z Keung · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2027-02-02
Completion
2027-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04875728 on ClinicalTrials.gov