What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Cystic Fibrosis, particularly antibiotics, can have various side effects. Inhaled tobramycin may cause bronchospasm, tinnitus, and voice alterations. Aztreonam can lead to cough, nasal congestion, and wheezing. Ciprofloxacin, an oral antibiotic, may cause gastrointestinal disturbances, tendonitis, and photosensitivity. Colistin, used both inhaled and intravenously, can result in nephrotoxicity and neurotoxicity. Tetracycline derivatives, like Omadacycline, often cause gastrointestinal upset, photosensitivity, and, less commonly, hepatotoxicity. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of Cystic Fibrosis, particularly targeting chronic pulmonary infections caused by Pseudomonas aeruginosa. Notable approvals include inhaled tobramycin, which has shown significant efficacy in eradicating P. aeruginosa, and inhaled aztreonam, which provides similar outcomes. Colistin is another antibiotic used for inhalation therapy in CF patients. Additionally, azithromycin, a macrolide, has been approved for its dual role in reducing pulmonary exacerbations and its anti-inflammatory effects. These treatments aim to manage chronic infections and improve the quality of life for CF patients.

What other types of research exist?

Promising alternatives to Omadacycline for CF patients include Sarecycline, which has shown efficacy in treating moderate to severe acne and has a narrower spectrum of activity, potentially reducing resistance and gut microbiome disruption. Additionally, novel beta-lactamase inhibitor combinations like ceftazidime-avibactam may be effective against multidrug-resistant gram-negative bacilli, including Pseudomonas aeruginosa. These options should be considered in consultation with an infectious disease specialist.

← Back to Search

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

Must not have

Presence of an ongoing acute pulmonary exacerbation defined based on clinical signs & symptoms and an acute decline in relative FEV1 of 10% or greater

No alcohol, nicotine, or caffeine-containing products during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 days

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing an antibiotic called omadacycline, given through an IV or as a pill, in patients with cystic fibrosis. These patients often get lung infections from hard-to-treat bacteria. The goal is to find the best dose to effectively treat these infections. Omadacycline is approved in the United States for treating adults with certain bacterial infections.

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.

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.

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 below

Select...

I have been diagnosed with cystic fibrosis.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently experiencing a severe worsening of my lung condition.

Select...

I will not consume alcohol, nicotine, or caffeine during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC

Absolute Bioavailability

Cmax

+1 more

Awards & Highlights

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.

Trial 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

0 / 4Eligibility criteria met

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.