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Aminoglycoside Antibiotic

Gentamicin for Epidermolysis Bullosa

Phase 1 & 2

Recruiting

Led By Mei Chen, Ph.D

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 6 months

Awards & highlights

Study Summary

This trial will test whether intravenous gentamicin can improve the skin condition of people with RDEB by inducing "read-through" of their nonsense mutations, creating new C7 and AFs.

Eligible Conditions

Recessive Dystrophic Epidermolysis Bullosa

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Absence of gentamicin side effects

Full-length type VII collagen expression

Generation of anchoring fibrils

Secondary outcome measures

Improved Disease Activity scores

Improved Quality of Life score

Side effects data

From 2013 Phase 4 trial • 614 Patients • NCT00926796

40%

Nausea

22%

Diarrhea

14%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Regimen B: Gemifloxacin Plus Azithromycin

Regimen A: Gentamicin Plus Azithromycin

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intravenous GentamicinExperimental Treatment1 Intervention

Intravenous gentamicin (7.5 mgs/kg) daily for for either 14 days and then stopped or twice weekly for three months and then stopped.

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

905 Previous Clinical Trials

1,596,269 Total Patients Enrolled

Mei Chen, Ph.DPrincipal InvestigatorProfessor, University of Southern California

David T. Woodley, MDPrincipal InvestigatorProfessor, University of Southern California

Media Library

Gentamicin (Aminoglycoside Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03392909 — Phase 1 & 2

Dystrophic Epidermolysis Bullosa Research Study Groups: Intravenous Gentamicin

Dystrophic Epidermolysis Bullosa Clinical Trial 2023: Gentamicin Highlights & Side Effects. Trial Name: NCT03392909 — Phase 1 & 2

Gentamicin (Aminoglycoside Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03392909 — Phase 1 & 2

Frequently Asked Questions

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

Are there any vacant positions in this clinical trial for new patients?

"That is accurate. The clinicaltrials.gov website has the latest information on this trial, which originally posted on July 5th, 2018 and was updated most recently on November 1st, 2022. They are looking for 9 more patients at a single location."

Answered by AI

How many volunteers are helping with this test?"

"Yes, according to the latest information on clinicaltrials.gov, this trial is still looking for participants. The posting went up on July 5th, 2018 and was last updated November 1st, 2020. Right now, they are enrolling 9 patients at a single site."

Answered by AI

What does Intravenous Gentamicin help alleviate?

"Intravenous Gentamicin is an effective means of treating ocular inflammation, corneal infection, and communicable diseases."

Answered by AI

Are there precedent studies to support the use of Intravenous Gentamicin?

"There are currently 14 clinical trials underway that focus on Intravenous Gentamicin. Of those, 6 are in Phase 3. Although many of the studies related to this treatment are based Louisville, Kentucky, there 56 total locations running these kinds of tests."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravenous Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

David Woodley 2018. "Intravenous Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03392909.

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