← 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
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 below
Select...
I have been diagnosed with cystic fibrosis.
Select...
I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC
Absolute Bioavailability
Cmax
+1 more

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

Find a Location

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

Omadacycline (Tetracycline Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04460586 — Phase 4
Cystic Fibrosis Research Study Groups: Omadacycline IV followed by PO
Cystic Fibrosis Clinical Trial 2023: Omadacycline Highlights & Side Effects. Trial Name: NCT04460586 — Phase 4
Omadacycline (Tetracycline Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04460586 — Phase 4

Frequently Asked Questions

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

For what conditions is Omadacycline Oral Tablet [Nuzyra] typically prescribed?

"Nuzyra [omadacycline oral tablet] is typically deployed to treat staphylococcus lugdunensis infections. However, it may also prove effective in treating enterobacter cloacae, enterococcus faecalis and klebsiella pneumoniae."

Answered by AI

Is recruitment still open for this clinical experiment?

"As per clinicaltrials.gov, this research endeavour is currently recruiting volunteers. The trial was initially posted on July 1st 2021 and has recently been updated on November 7th 2022."

Answered by AI

Is there a set limit to the quantity of participants in this experiment?

"Confirmed. Clinicaltrials.gov confirms that this clinical trial, first posted on July 1st 2021 is actively recruiting patients for the study. 12 participants are needed from one particular location before it can move forward with its research objectives."

Answered by AI

Would this experimental endeavor be considered groundbreaking?

"Paratek Pharmaceuticals Inc. has initiated two clinical trials for the drug Omadacycline Oral Tablet [Nuzyra], with 20 locations across one nation actively recruiting patients since 2021. The primary trial, containing 12 participants, successfully passed through Phase 4 of its approval process that same year. Subsequent studies have been finalized to date."

Answered by AI

Are there any precedents to the present experiment involving Omadacycline Oral Tablet [Nuzyra]?

"At present, 2 clinical trials are in progress for Omadacycline Oral Tablet [Nuzyra], with none at the Phase 3 stage. Notably, Atlanta Georgia has several sites enrolled in this research, with a total of 31 locations conducting studies related to Omadacycline Oral Tablets [Nuzyra]."

Answered by AI

Has Nuzyra, the Omadacycline Oral Tablet, earned governmental authorization?

"As this medical treatment is approved, our internal team at Power gave Omadacycline Oral Tablet [Nuzyra] a score of 3 in regards to safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics of Omadacycline in Cystic Fibrosis
Paul Beringer 2021. "Pharmacokinetics of Omadacycline in Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04460586.
~2 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top