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Antibiotic

Lefamulin for Cystic Fibrosis

Phase 1

Waitlist Available

Research Sponsored by Nabriva Therapeutics AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study Summary

This trial will study the effects of a new antibiotic, lefamulin, in people with Cystic Fibrosis.

Eligible Conditions

Cystic Fibrosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cystic Fibrosis

Side effects data

From 2017 Phase 3 trial • 551 Patients • NCT02559310

Insomnia

Infusion Site Pain

Hypokalaemia

Nausea

Infusion Site Phlebitis

Alanine Aminotransferase Increased

Pneumonia

Diarrhoea

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Lefamulin

Moxifloxacin ± Linezolid

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group BExperimental Treatment1 Intervention

Group B will receive one dose of 600 mg lefamulin oral followed by one dose of 150 mg lefamulin IV

Group II: Group AExperimental Treatment1 Intervention

Group A will receive one dose of 150 mg lefamulin IV followed by one dose of 600 mg lefamulin oral

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lefamulin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nabriva Therapeutics AGLead Sponsor

9 Previous Clinical Trials

2,068 Total Patients Enrolled

Frequently Asked Questions

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

Has the federal agency sanctioned Lefamulin as a viable treatment option?

"Because this is a Phase 1 trial, with limited data on efficacy and safety, our team at Power assigned Lefamulin a score of one."

Answered by AI

Are individuals aged seventy or above being enrolled for this experiment?

"This medical trial is available to individuals aged 18 - 80. For those below the age of consent, there are 86 trials and 373 for senior citizens over 65 years old."

Answered by AI

Is it possible for me to become a participant in this experiment?

"This clinical trial requires a cohort of 13 adults aged 18 to 80 who have cystic fibrosis, and meet the following criteria: providing written consent; having undergone genetic testing confirming their diagnosis; weighing more than 40kgs.; possessing an FEV1 level greater than 40% as per most recent assessment; being mentally and physically fit for participation in the study with no major health changes within 28 days prior to Day 1; maintaining normal body temperature below 38°C systolic blood pressure ranging from 90-160mmHg diastolic blood pressure between 50-90 mmHg and a resting heart rate less than 100 beats per minute"

Answered by AI

Are there still openings available to participate in this research endeavor?

"While it appears on clinicaltrials.gov that this trial is not active in securing new candidates, the study was initially posted at the beginning of March 2022 and last updated mid-August 2022. In comparison to other medical trials, there are currently 412 studies actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis

2022. "Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05225805.