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Antibiotic

Antibiotic Care for Fractures

Phase 3
Recruiting
Led By Renan C Castillo, PhD
Research Sponsored by Major Extremity Trauma Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gustilo type IIIB talus fractures (OTA 81)
Ages 18 - 64 years inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 days from injury
Awards & highlights

Study Summary

This trial will compare a new treatment protocol to the current standard of care for patients with certain types of fractures.

Who is the study for?
Adults aged 18-64 with severe open fractures of the tibia, ankle, or hindfoot that require further surgery after initial stabilization. Suitable for those with additional injuries or risk factors like diabetes and immunosuppression. Not for intellectually challenged individuals without support, those unlikely to follow up due to location or lack of contact means, prisoners, or patients already receiving infection treatment at the study site.Check my eligibility
What is being tested?
The SEXTANT trial is comparing standard care against a new protocol involving Vancomycin and Tobramycin in treating Type III open fractures. It's a multi-center study where participants are randomly chosen to receive either the current standard treatment or the experimental antibiotic regimen.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to antibiotics (like rashes), kidney issues from Tobramycin, hearing problems also related to Tobramycin, and possible antibiotic resistance leading to less effective treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a severe ankle fracture.
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I am between 18 and 64 years old.
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I have a severe heel bone fracture.
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I need surgery for my below-knee amputation wound.
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I have a severe open ankle fracture.
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I need a second surgery for my severe lower leg injury after the first stabilization.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 days from injury
This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days from injury for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Deep surgical site infection
Fracture revision rates

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
The patients in the SEXTANT cohort will have 1000 mg of Vancomycin and 1200 mg of Tobramycin administered to the wound surface, fracture site and exposed hardware (if any) just prior to suture closure of the wound or flap. The SEXTANT cohort will then receive at least 72 hours of systemic antibiotic therapy targeted to the modern wound bioburden.
Group II: ControlActive Control1 Intervention
Participants in the control group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
863 Previous Clinical Trials
226,399 Total Patients Enrolled
Major Extremity Trauma Research ConsortiumLead Sponsor
31 Previous Clinical Trials
26,178 Total Patients Enrolled
Renan C Castillo, PhDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
2 Previous Clinical Trials
2,080 Total Patients Enrolled

Media Library

Tobramycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04678154 — Phase 3
Surgical Site Infection Research Study Groups: Control, Treatment
Surgical Site Infection Clinical Trial 2023: Tobramycin Highlights & Side Effects. Trial Name: NCT04678154 — Phase 3
Tobramycin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04678154 — Phase 3

Frequently Asked Questions

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

Are Vancomycin and Tobramycin being trialed for other purposes?

"Currently, there are 68 ongoing clinical trials examining Vancomycin and Tobramycin. 9 of those trials have reached Phase 3. Although the majority of these studies originated in São Paulo, SP, there are 315 total active locations for this research."

Answered by AI

For what sorts of infections are Vancomycin and Tobramycin commonly given to patients?

"Vancomycin and Tobramycin are typically used to vanquish bacterial infections. However, in some cases, the medication can be used to treat other conditions like burkholderia cepacia infection, eye infections, and ocular bacterial infections."

Answered by AI

What is the age limit for patients in this particular clinical trial?

"The age range for patients enrolling in this trial is from 18 to 64. If you are looking for studies including patients under 18, there are 22. If you are looking for studies including patients over 65, there are 139."

Answered by AI

If I wanted to, could I join this experiment?

"This study is seeking 1200 participants that fit the following criteria: between the ages of 18 and 64, currently have a surgical wound infection, and meet one or more of the following risk factors for infection: diabetes, immunosuppression from steroids or other medications, HIV, or other infections; have had a zone-of-injury trans-tibial amputation requiring DPC and/or flap coverage; have a traumatic brain injury; have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries; or were treated initially"

Answered by AI

How many individuals are included in this experiment?

"The correct answer is that this trial is currently recruiting patients, according to information found on clinicaltrials.gov. The trial was first posted on May 7th, 2021 and was last edited on August 22nd, 2022. The trial is enrolling 1200 participants at 1 site."

Answered by AI

Is this an innovative study?

"There are a total of 68 active studies being conducted for Vancomycin and Tobramycin in 155 cities across 22 countries. The first clinical trial was sponsored by Erempharma in 2010 and only involved 12 patients. The drug approval stage for this study is N/A. In the 10 years since 2010, 337 studies have been completed."

Answered by AI

Could you please summarize the side effects of Vancomycin and Tobramycin?

"There is some evidence from previous clinical trials to support the efficacy of Vancomycin and Tobramycin, as well as data from multiple rounds of safety testing. As such, our team has rated the safety of these drugs as a 3."

Answered by AI

Are researchers currently looking for new participants for this project?

"Yes, this is an active trial that was posted on 2021-05-07 and updated on 2022-08-22. They are looking for 1200 participants from 1 site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
2021. "Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04678154.
~150 spots leftby Sep 2024
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