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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2027-02-02

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVE:

I. To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patient's gut microbiome.

SECONDARY OBJECTIVES:

I. To characterize the dynamics of the immune response to surgical intervention in the absence and presence of pre-operative prophylactic antibiotics, focusing on the immune profile of the peripheral blood leukocytes as well as the balance of circulating pro- and anti-inflammatory cytokines and metabolomic profiles.

II. To assess surgical site infection (SSI) in the absence and presence of pre-operative prophylactic antibiotics at time of surgical resection.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive cefazolin intravenously (IV) and then undergo standard of care surgical resection within 1 hour.

ARM B: Patients undergo standard of care surgical resection.

After completion of study treatment, patients are followed up at 3 days, 2 weeks, and 3 months.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (cefazolin, surgical resection)

Patients receive cefazolin IV and then undergo standard of care surgical resection within 1 hour.

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

Given IV

Resection

Intervention Type PROCEDURE

Undergo standard of care surgical resection

Arm B (surgical resection)

Patients undergo standard of care surgical resection.

Group Type EXPERIMENTAL

Resection

Intervention Type PROCEDURE

Undergo standard of care surgical resection

Interventions

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Cefazolin

Given IV

Intervention Type DRUG

Resection

Undergo standard of care surgical resection

Intervention Type PROCEDURE

Other Intervention Names

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Surgical Resection

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No