← Back to Search

Aminoglycoside Antibiotic

Biweekly IV Gentamicin for Epidermolysis Bullosa

Phase 1 & 2

Recruiting

Led By Mei Chen, PhD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial will test if gentamicin can help treat H-JEB by increasing laminin 332 at the DEJ and improving EB Disease Activity Scores with no side effects.

Eligible Conditions

Epidermolysis Bullosa Junctional

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

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

Primary outcome measures

Laminin 332 Expression in Skin

Safety (Autoimmune Response)

Safety (Nephrotoxicity)

+1 more

Secondary outcome measures

Epidermolysis Bullosa Disease and Activity and Scarring Index (EBDASI)

Wound Healing

Trial Design

2Treatment groups

Experimental Treatment

Group I: Daily IV GentamicinExperimental Treatment1 Intervention

Once daily (for 24 days) IV infusions of 10 mg/kg gentamicin delivered over a 30-60 minute period.

Group II: Biweekly IV GentamicinExperimental Treatment1 Intervention

Twice weekly (for 3 months or 24 total) IV infusions of 10 mg/kg gentamicin delivered over a 30-60 minute period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gentamicin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,596,151 Total Patients Enrolled

4 Trials studying Epidermolysis Bullosa

26 Patients Enrolled for Epidermolysis Bullosa

Mei Chen, PhDPrincipal InvestigatorUniversity of Southern California

Media Library

Gentamicin Sulfate (Aminoglycoside Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04140786 — Phase 1 & 2

Epidermolysis Bullosa Research Study Groups: Biweekly IV Gentamicin, Daily IV Gentamicin

Epidermolysis Bullosa Clinical Trial 2023: Gentamicin Sulfate Highlights & Side Effects. Trial Name: NCT04140786 — Phase 1 & 2

Gentamicin Sulfate (Aminoglycoside Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04140786 — Phase 1 & 2

Frequently Asked Questions

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

How many participants are being observed in this research project?

"Affirmative. Clinicaltrials.gov details that this clinical trial, initially posted on October 31st 2019, is currently open for recruitment. Six individuals are required at one medical centre to take part in the study."

Answered by AI

What other investigations have been conducted with respect to Biweekly IV Gentamicin?

"Thirteen research studies for Biweekly IV Gentamicin are currently underway, with 5 of them situated in Phase 3. Louisville, Kentucky is among the many locations that have launched clinical trials concerning this particular medication; there are 55 sites running these trials altogether."

Answered by AI

What conditions is Biweekly IV Gentamicin administered to treat?

"Biweekly IV Gentamicin has been clinically demonstrated to be effective at managing ocular inflammation, corneal infection, and communicable illnesses."

Answered by AI

Is enrollment currently available for this experiment?

"Clinicaltrials.gov has this study listed as actively recruiting patients, with an initial post date of October 31st 2019 and a most recent update on November 1st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing IV Gentamicin in JEB

David Woodley 2019. "Optimizing IV Gentamicin in JEB". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04140786.