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Tetracycline Antibiotic
Omadacycline for Cystic Fibrosis
Phase 4
Waitlist Available
Research Sponsored by Paul Beringer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of CF based on positive sweat chloride or known CF mutation
Age >=18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 days
Awards & highlights
Study Summary
This trial will study how well the antibiotic omadacycline works in patients with cystic fibrosis when taken by mouth or given intravenously.
Who is the study for?
Adults over 18 with cystic fibrosis confirmed by a sweat test or genetic mutation can join this trial. It's not for those who are pregnant, breastfeeding, consume alcohol, nicotine, or caffeine during the study period, have had serious allergies to tetracycline antibiotics, very low hemoglobin levels, or are currently having a severe lung flare-up.Check my eligibility
What is being tested?
The trial is testing how omadacycline (given as an injection and as an oral tablet) behaves in the body of someone with cystic fibrosis. The goal is to understand the drug's movement and changes inside these patients.See study design
What are the potential side effects?
Omadacycline may cause side effects similar to other antibiotics in its class like nausea, vomiting, sun sensitivity, teeth discoloration if used long-term from childhood and could potentially affect liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with cystic fibrosis.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC
Absolute Bioavailability
Cmax
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Omadacycline IV followed by POExperimental Treatment2 Interventions
Omadacycline 100mg IV, Omadacycline 300 mg tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omadacycline
FDA approved
Omadacycline
FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Cystic Fibrosis, particularly antibiotics like Omadacycline, work by targeting bacterial infections that exacerbate lung disease in CF patients. Omadacycline, a tetracycline derivative, inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, preventing the addition of amino acids to the growing peptide chain.
This is crucial for CF patients as they are prone to chronic and recurrent lung infections due to thick mucus in their airways, which provides a breeding ground for bacteria. Effective antibiotic therapy helps manage these infections, reduce inflammation, and improve lung function, thereby enhancing the quality of life and overall prognosis for CF patients.
Drugs, Drugs, Drugs: Current Treatment Paradigms in Cystic Fibrosis Airway Infections.Mutation-specific therapies and drug repositioning in cystic fibrosis.
Drugs, Drugs, Drugs: Current Treatment Paradigms in Cystic Fibrosis Airway Infections.Mutation-specific therapies and drug repositioning in cystic fibrosis.
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Who is running the clinical trial?
Paratek Pharmaceuticals IncIndustry Sponsor
16 Previous Clinical Trials
4,004 Total Patients Enrolled
Paul BeringerLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
24 Patients Enrolled for Cystic Fibrosis
Adupa P Rao, M.D.Study DirectorKeck Medicine of USC
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with cystic fibrosis.I am currently experiencing a severe worsening of my lung condition.I will not consume alcohol, nicotine, or caffeine during the study.You have had a severe allergic reaction to a tetracycline antibiotic in the past.Your hemoglobin level is less than 8 grams per deciliter.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Omadacycline IV followed by PO
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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