Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875728
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2020-10-05
Brief Title:
The Impact of an Antibiotic Cefazolin Before Surgery on the Microbiome in Patients With Stage I-II Melanoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Evaluating the Impact of Perioperative Antibiotic Prophylaxis on the Microbiome in Patients With Cutaneous Malignancy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 bodys ability to respond to surgery and cancer
Detailed Description:
PRIMARY OBJECTIVE
I To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patients 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
I To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-0265 | OTHER | M D Anderson Cancer Center | None |
| NCI-2020-07071 | REGISTRY | None | None |