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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
Summary
This trial is testing an antibiotic called omadacycline to treat adults with a specific lung infection. The antibiotic works by stopping the bacteria from growing. Participants will take the treatment for several months. Omadacycline is a once-daily oral antibiotic approved in the United States for the treatment of certain bacterial infections in adults.
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.
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.
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 belowSelect...
I have been diagnosed with a lung infection caused by MABc.
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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.
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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 weeks1 visit
Treatment ~ Varies
Follow Up ~ 30 days1 visit
Screening ~ 8 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes from baseline in electrocardiogram (ECG)
Changes from baseline in laboratory tests
Changes from baseline in vital signs
+5 moreSecondary study objectives
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 moreTrial 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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken steroids for a chronic condition in the last 3 months.I have been treated with omadacycline before.I have at least two symptoms like coughing, chest pain, or weight loss due to NTM infection.I have not had cancer treatments in the last year.My doctor thinks I won't need antibiotics for my condition in the next 3 months.I have been diagnosed with a lung infection caused by MABc.I have taken antibiotics in the last 6 months for MABc or MAC.I have active tuberculosis in my lungs.My lung function is severely reduced.I have cystic fibrosis.I have at least 2 symptoms like coughing, chest pain, or weight loss.My recent CT scan shows signs of a MABc infection in my chest.I can cough up sputum on my own or with help.I have not taken antibiotics, except for chronic macrolides, in the last 4 weeks.My NTM infection has spread beyond my lungs.You have had a lung transplant in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Omadacycline 300 mg PO
- Group 2: Placebo PO
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 8 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 84 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 30 Months after you stop receiving the treatment.
Nontuberculous Mycobacterial Lung Disease Patient Testimony for trial: Trial Name: NCT04922554 — Phase 2
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