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Antibiotic

Budesonide + Azithromycin for Laryngeal Injury after Intubation

Phase 1 & 2
Recruiting
Led By Alexander Gelbard, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Patients with head and neck malignancies
Age under 18 years on admission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 72 hours of extubation
Awards & highlights
Approved for 30 Other Conditions
All Individual Drugs Already Approved

Summary

This trial is aimed at investigating laryngeal injuries caused by intubation and determining risk factors to help reduce incidence or speed up diagnosis.

Who is the study for?
This trial is for English-speaking adults who've been intubated in the ICU for 24 hours to 7 days. It's not for those under 18, pregnant/breastfeeding individuals, patients unable to consent, with certain heart conditions or severe hearing loss, neck trauma, head/neck cancers, expected early discharge post-extubation, dependent on others pre-admission, with pre-existing airway or respiratory conditions like COPD or asthma, previous long-term intubation history, allergies to study drugs or a high resting heart rate.
What is being tested?
The trial aims to measure how common acute and chronic laryngeal injuries are after intubation and identify risk factors. It includes a randomized control test where some patients will receive Budesonide and Azithromycin while others get placebo controls. The goal is to see if these medications can improve breathing in patients with Acute Laryngeal Injury from intubation.
What are the potential side effects?
Possible side effects of Budesonide may include irritation of the throat, coughing and dry mouth; Azithromycin could cause digestive issues like nausea and diarrhea as well as potential allergic reactions. Placebos typically have no active ingredients but can lead to perceived side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer in my head or neck.
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I am under 18 years old.
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I have needed help with daily activities for the last 30 days.
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I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 72 hours of extubation
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 72 hours of extubation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute Laryngeal Injury
Chronic Obstructive Pulmonary Disease Dyspnea Questionnaire (CCQ)
Secondary study objectives
Chronic Laryngeal Injury

Awards & Highlights

Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Medical TherapyExperimental Treatment1 Intervention
medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days
Group II: Placebo ControlPlacebo Group1 Intervention
Placebo control medication for 14 days

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
902 Previous Clinical Trials
938,437 Total Patients Enrolled
Alexander Gelbard, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
Tulane University School Of Medicine (Medical School)
2 Previous Clinical Trials
1,239 Total Patients Enrolled

Media Library

Azithromycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03250975 — Phase 1 & 2
Endotracheal Intubation Research Study Groups: Medical Therapy, Placebo Control
Endotracheal Intubation Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT03250975 — Phase 1 & 2
Azithromycin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03250975 — Phase 1 & 2
~1 spots leftby Dec 2024
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