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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 72 hours of extubation
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
853 Previous Clinical Trials
671,004 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

Frequently Asked Questions

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

Are there still vacancies for participants to join this research project?

"According to the clinicaltrials.gov database, this medical experiment is now enrolling participants. It was first advertised on August 19th 2017 and had its most recent update on November 3rd 2022."

Answered by AI

What is the extent of enrollment for this scientific trial?

"Affirmative. According to records on clinicaltrials.gov, this medical trial is currently seeking patients and was originally posted in August 2017 before being updated most recently in November 2022. Approximately 64 people are required across a single site for the study to move forward."

Answered by AI

What other empirical assessments have been made regarding Budesonide and Azithromycin as treatments?

"At present, 84 clinical investigations are being conducted with a combination of Budesonide and Azithromycin. 27 have progressed to Phase 3. These trials are chiefly located in McKinney, Texas; however, there is an expansive network of research centres across 1677 sites worldwide running studies for this therapeutic approach."

Answered by AI

To what end are Budesonide and Azithromycin usually administered?

"Budesonide and Azithromycin are commonly prescribed to manage rhino sinusitis. They may also be effective at treating genital ulcer disease (GUD), vasomotor rhinitis, or acute coryza."

Answered by AI
~7 spots leftby Dec 2024