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Antibiotic

Lefamulin for Mycoplasma Genitalium Infection

Phase 1 & 2
Waitlist Available
Led By Lisa E Manhart, PhD, MPH
Research Sponsored by University of Washington
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 21-28 days after completion of the lefamulin
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if the antibiotic lefamulin can cure difficult Mycoplasma genitalium infections, either alone or after taking doxycycline. It targets patients whose infections haven't responded to other treatments. Lefamulin works by stopping bacteria from making proteins they need to survive. Lefamulin is the first of its kind to be available for therapeutic use in humans.

Eligible Conditions
  • Mycoplasma Genitalium Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21-28 days after completion of the lefamulin
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21-28 days after completion of the lefamulin for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number and Percentage of Participants With Microbiologic Cure
Secondary study objectives
Number and Percentage of Participants With Sustained Microbiologic Cure

Side effects data

From 2023 Phase 1 trial • 13 Patients • NCT05225805
15%
Diarrhea
15%
Nausea
8%
Vomiting
8%
Infusion site erythema
8%
Infusion site pain
8%
Presyncope
8%
Tooth fracture
8%
Cystic fibrosis gastrointestinal disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total
Lefamulin Oral Treatment
Lefamulin IV Treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Lefamulin aloneExperimental Treatment1 Intervention
Lefamulin 600mg tablet orally twice daily for 7 days
Group II: Doxycycline followed by lefamulinExperimental Treatment2 Interventions
Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lefamulin
2015
Completed Phase 1
~40
Doxycycline
2008
Completed Phase 4
~2650

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,820 Previous Clinical Trials
1,914,661 Total Patients Enrolled
Nabriva Therapeutics AGIndustry Sponsor
9 Previous Clinical Trials
2,069 Total Patients Enrolled
Lisa E Manhart, PhD, MPHPrincipal InvestigatorUniversity of Washington
~3 spots leftby Dec 2025
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