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Anti-bacterial

Tobramycin Injection for Open Fractures

Phase 3
Recruiting
Led By Arun Aneja, MD, PhD
Research Sponsored by David Landy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Over the age of 18
Open fracture to arm, leg, or both
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether a combination of local and systemic antibiotics can reduce the rate of infection in people with open fractures.

Who is the study for?
Adults over the age of 18 with an open fracture to an arm or leg are eligible for this trial. It's not suitable for those under 18, pregnant individuals, or anyone allergic to tobramycin or aminoglycoside antibiotics.Check my eligibility
What is being tested?
The study is testing if injecting Tobramycin directly into the wound during surgery can prevent infections better than just using standard IV antibiotics in people with open fractures.See study design
What are the potential side effects?
While local Tobramycin aims to minimize systemic side effects, potential risks may include hearing issues, kidney problems, and nerve damage but these are generally rare when used locally.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
Select...
I am over 18 years old.
Select...
I have an open fracture in my arm, leg, or both.

Timeline

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
Rate of infection
Secondary outcome measures
Difference in antibiotic resistance between treatment and standard of care group.
Difference in bacterial specification between treatment and standard of care group.
Tobramycin effects on non-union

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tobramycin Treatment GroupExperimental Treatment1 Intervention
Participants in this group receive a local aqueous tobramycin injection (2mg/mL) plus standard of care treatment.
Group II: Standard of Care Treatment GroupActive Control1 Intervention
Participants in this group receive standard of care treatment.

Find a Location

Who is running the clinical trial?

David LandyLead Sponsor
Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,192,823 Total Patients Enrolled
Arun AnejaLead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Tobramycin Injection (Anti-bacterial) Clinical Trial Eligibility Overview. Trial Name: NCT04964947 β€” Phase 3
Fractures Research Study Groups: Standard of Care Treatment Group, Tobramycin Treatment Group
Fractures Clinical Trial 2023: Tobramycin Injection Highlights & Side Effects. Trial Name: NCT04964947 β€” Phase 3
Tobramycin Injection (Anti-bacterial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04964947 β€” Phase 3

Frequently Asked Questions

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

Are patients of a certain age being excluded from this research?

"This particular clinical trial is only recruiting patients that fall between 18 to 80 years old. In comparison, there are 286 clinical trials for people under the age of 18 and 973 for elderly people."

Answered by AI

For what disorders is Tobramycin Injection most often prescribed?

"Tobramycin Injection can be used to fight off bacterial infections like burkholderia cepacia infection and eye infections."

Answered by AI

How many volunteers are taking part in this experiment?

"That is correct. The clinicaltrials.gov website currently has information indicating that this trial is seeking participants. The trial was originally posted on 1/10/2022 and was last updated on 1/28/2022. The trial is looking for 300 participants across 1 site."

Answered by AI

Could you please share what other research has been done on Tobramycin Injection?

"Currently, there are 12 clinical trials studying the effects of Tobramycin Injection. 5 of these trials are in Phase 3. Most of the trials are taking place in Aurora, Colorado, but there are also 16 other locations across the country where these trials are taking place."

Answered by AI

Has the FDA cleared Tobramycin Injection for public use?

"There is a fair amount of data supporting tobramycin injection's efficacy and safety, so it received a score of 3."

Answered by AI

How can I become a participant of this experiment?

"This research study is open to 300 people that have suffered fractures. The fracture must be open and the victim must be between 18-80 years old. There are additional requirements that the fracture be in the arm, leg, or both."

Answered by AI

Are there any more people needed for this clinical test?

"This clinical trial is still recruiting patients, according to the latest information on clinicaltrials.gov. The trial was originally posted on January 10th, 2022, and was last updated on January 28th, 2022."

Answered by AI

What makes this particular clinical trial different from others?

"Tobramycin Injection is being studied in 12 ongoing clinical trials spread out over 9 cities and 7 countries. The first trial for Tobramycin Injection was held in 2010 and, since then, 495 studies have been completed."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
~237 spots leftby Sep 2025