IO Vancomycin Spine

NCT06748144 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: PRO00038766
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to learn if injecting the antibiotic vancomycin directly into the bone marrow (intraosseous) or IO) during a lumbar (spinal) fusion surgery, is as effective or better than the standard method of giving it vancomycin through a vein (intravenous) or IV) during lumbar fusion surgery.

Conditions

Lumbar Fusion Surgery

Outcome Measures

Primary Outcomes (3)

• Change in Level of Systemic Vancomycin Concentration

  The level of vancomycin concentration will be assessed via a blood draw by the anesthesiologist staff.

  Start of skin incision during surgery, Start of closure of skin incision during surgery

• Level of Vancomycin Concentration in Bone

  Bony tissue samples (Superior Articular Process, Inferior Articular Process, and Lamina) will be taken during surgery to assess levels of vancomycin concentration in the bone.

  During surgery

• Level of Vancomycin Concentration in Soft Tissue

  Soft tissue samples (Multifidus muscle, Fat) will be taken during surgery to assess levels of vancomycin concentration in the tissue.

  During surgery

Secondary Outcomes (1)

• Post-Operative Complication Rates

  30 Days Post Surgery, 90 Days Post Surgery

Study Arms (2)

Intraosseous Vancomycin

EXPERIMENTAL

Participants in this group will receive other antibiotics according to the Houston Methodist Hospital orthopedic surgeon's standard of care regimen, which typically involves ancef or cefepime being administered in pre-op within 1 hour of the incision. IO Vancomycin will be administered in the OR after incision (500mg in 100-150mL normal saline (NS)), and the injection will be placed into the posterior ilium.

Drug: Intraosseous Vancomycin

Intravenous Vancomycin

ACTIVE COMPARATOR

Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for lumbar fusion patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin), which will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500mL NS).

Drug: Intravenous Vancomycin

Interventions

Intraosseous Vancomycin DRUG

The intervention is specific to the method of administration that will be used when giving the dose of antibiotic vancomycin which is done to prevent infection following surgery.

Intraosseous Vancomycin

Intravenous Vancomycin DRUG

This is the standard method of giving the antibiotic vancomycin to patients undergoing surgery across many specialties in order to prevent infection.

Intravenous Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is undergoing open posterior instrumented spinal fusion (PSIF) or transforaminal lumbar interbody fusion (TLIF)
• Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study
• Age Range \>18

You may not qualify if:

• Previous spine surgery if surgeon deems it will affect the study
• BMI \> 40
• Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
• Inability to administer the IO infusion
• Refusal to participate
• Diabetes as defined as uncontrolled A1C \> 7.5 and eGFR \<59
• Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo/radiation treatment in last 6 months, medications)
• No vulnerable populations

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Central Study Contacts

Emily Vidal

CONTACT

346-238-4675; evidal@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)