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Anti-infective Agent

Experimental Intraosseous vancomycin 500mg in 250 mL NS for Prosthetic Joint Infections

Phase 4

Waitlist Available

Led By Terry A Clyburn, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new way of giving vancomycin to patients undergoing hip surgery, to see if it is better than the standard IV method.

Eligible Conditions

Prosthetic Joint Infections
Arthritis
Vancomycin

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Systemic Vancomycin level

Secondary outcome measures

30-Day Complications

90-Day Complications

Acetabulum vancomycin level

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IO Vancomycin 500mg in 250 mL NSExperimental Treatment1 Intervention

Experimental Intraosseous administration protocol.

Group II: IV administration of vancomycinActive Control1 Intervention

Standard IV vancomycin administration protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vancomycin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

271 Previous Clinical Trials

80,372 Total Patients Enrolled

1 Trials studying Prosthetic Joint Infections

15 Patients Enrolled for Prosthetic Joint Infections

Terry A Clyburn, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with administering 500mg of vancomycin in 250mL of normal saline to human subjects?

"A score of 3 was assigned to Experimental Intraosseous vancomycin 500mg in 250 mL NS based on its approval as a Phase 4 trial, indicating that safety and efficacy have been successfully demonstrated."

Answered by AI

What medical conditions are ameliorated by administering Experimental Intraosseous vancomycin 500mg in 250 mL NS?

"Staph-related illnesses such as staphylococcal infections, enterocolitis caused by Staphylococcus aureus, can be managed with Experimental Intraosseous vancomycin 500mg in 250 mL NS."

Answered by AI

Are recruitment efforts for this trial still underway?

"Affirmative. As indicated on clinicaltrials.gov, this trial is currently recruiting volunteers and opened up submissions on December 31st 2019. The last update was provided August 30th 2021 with the aim of enrolling 30 participants at one particular site."

Answered by AI

How many participants are being monitored in this research endeavor?

"Affirmative. According to the information available on clinicaltrials.gov, this medical trial is currently recruiting participants who meet its criteria. This experiment was initially posted in December 31st 2019 and revised as recently as August 30th 2021. Thirty individuals will be taken from one research centre for enrolment into the study."

Answered by AI

Could you provide information on previous research involving the administration of 500mg Intraosseous vancomycin in 250mL NS?

"Presently, 55 trials for Experimental Intraosseous vancomycin 500mg in 250 mL NS are ongoing. Of these active studies, 6 have reached Phase 3. Jupiter, Florida is the primary hub of these medical examinations; nonetheless there are 315 trial sites across the United States that offer this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

Terry Clyburn 2019. "Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04042233.