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Tetracycline Antibiotic

Omadacycline for Nontuberculous Mycobacterial Lung Disease

Phase 2
Recruiting
Research Sponsored by Paratek Pharmaceuticals Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a diagnosis of Nontuberculous Mycobacterial pulmonary disease caused by MABc
Has at least 2 of the following NTM-infection symptoms present at Screening and Baseline: chronic cough, coughing up blood (hemoptysis), wheezing, chest pain, frequent throat clearing, phlegm or sputum production, shortness of breath, fatigue, fever, night sweats, poor appetite, and/or weight loss.
Timeline
Screening 8 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial will test if omadacycline is better than placebo at treating NTM pulmonary disease caused by MABc.

Who is the study for?
Adults with NTM lung disease caused by Mycobacterium abscessus complex, who have symptoms like chronic cough or chest pain, and positive cultures for MABc. They shouldn't need immediate antibiotic treatment and haven't had certain treatments in the past 6 months.Check my eligibility
What is being tested?
The trial is testing if Omadacycline tablets are better than a placebo (no active drug) at treating NTM pulmonary disease caused by MABc. It's focused on how well it works, its safety, and if people can tolerate it.See study design
What are the potential side effects?
Possible side effects of Omadacycline may include typical reactions to antibiotics such as stomach upset, nausea, vomiting, diarrhea, allergic reactions or increased sensitivity to sunlight.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a lung infection caused by MABc.
Select...
I have at least 2 symptoms like coughing, chest pain, or weight loss.
Select...
My recent CT scan shows signs of a MABc infection in my chest.
Select...
I can cough up sputum on my own or with help.
Select...
I have at least two symptoms like coughing, chest pain, or weight loss due to NTM infection.

Timeline

Screening ~ 8 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 8 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes from baseline in electrocardiogram (ECG)
Changes from baseline in laboratory tests
Changes from baseline in vital signs
+5 more
Secondary outcome measures
Change from baseline in Clinical Global Impression - Improvement (CGI-I)
Change from baseline in Clinical Global Impression - Severity of Illness (CGI-S)
Change from baseline in Patient Clinical Impression of Change (PGI-C)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Omadacycline 300 mg POExperimental Treatment1 Intervention
omadacycline 150 mg tablets (x 2) administered orally, once daily, q24h
Group II: Placebo POPlacebo Group1 Intervention
Placebo tablets resembling omadacycline (x 2) administered once daily, q24h

Find a Location

Who is running the clinical trial?

Paratek Pharmaceuticals IncLead Sponsor
16 Previous Clinical Trials
3,938 Total Patients Enrolled
Gail Berman, MDStudy ChairParatek Pharmaceuticals Inc

Media Library

Omadacycline (Tetracycline Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04922554 — Phase 2
Nontuberculous Mycobacterial Lung Disease Research Study Groups: Omadacycline 300 mg PO, Placebo PO
Nontuberculous Mycobacterial Lung Disease Clinical Trial 2023: Omadacycline Highlights & Side Effects. Trial Name: NCT04922554 — Phase 2
Omadacycline (Tetracycline Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04922554 — Phase 2
Nontuberculous Mycobacterial Lung Disease Patient Testimony for trial: Trial Name: NCT04922554 — Phase 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 slots remaining in this clinical experiment for prospective participants?

"According to the clinicaltrials.gov database, this trial is in its recruitment phase; it was launched on October 15th 2021 and updated most recently on November 17th 2022."

Answered by AI

What potential risks can be associated with Omadacycline Oral Tablet utilization?

"While there is some evidence of safety with Omadacycline Oral Tablet, the lack of clinical data supporting efficacy resulted in a score of 2."

Answered by AI

Is this medical experiment being conducted in multiple locations within the city?

"This clinical trial is currently running at 30 different sites, including Tyler, Saint Louis and Liverpool. To reduce the burden of travel for potential participants, it is best to join a study in a location nearby."

Answered by AI

What is the current enrollment size for this clinical experiment?

"To fulfil the requirements of this clinical trial, 75 patients must meet the inclusion criteria and be located at any one of several medical centres. The sponsor for this project is Paratek Pharmaceuticals Inc., who will oversee operations from sites such as Tyler, Texas' Medical Facility and Saint Louis Missouri's University of Texas Health Science Center locations."

Answered by AI

What diseases does Omadacycline Oral Tablet address?

"Omadacycline Oral Tablet is mainly used to address staphylococcus lugdunensis, however it has been known to be an effective intervention for conditions such as enterobacter cloacae, enterococcus faecalis and klebsiella pneumoniae."

Answered by AI

Are there any analogous experiments using Omadacycline Oral Tablet?

"Currently, there are 2 active clinical trials exploring the effects of Omadacycline Oral Tablet with 0 Phase 3 studies. Most research sites for this drug are centered in Atlanta, Georgia; however, 31 other locations also have running trials concerning Omadacycline Oral Tablet."

Answered by AI

Is this the pioneering research of its kind?

"Currently, two trials are taking place involving Omadacycline Oral Tablet in 20 cities across a single nation. The initial study for the drug was conducted by Paratek Pharmaceuticals Inc in 2021 and enrolled twelve participants, concluding its Phase 4 approval stage. Since then, 18334 additional tests have been successfully completed."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
New York
Texas
Other
What site did they apply to?
Medical Facility
Einstein/Montefiore Medical Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
1
0

Why did patients apply to this trial?

I want to help. I have the worst lungs. I grew up an athlete and never could breathe. Cardio was the worst. I was strong as heck. I am asthmatic. Supposedly. I thonk/know it is worse than asthma.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Medical University of South Carolina (MUSC): < 24 hours
  2. Einstein/Montefiore Medical Center: < 48 hours
  3. Northwell Health: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)
2021. "Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04922554.
~21 spots leftby May 2025
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