Lefamulin for M. Genitalium Treatment Failures

NCT05111002 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: STUDY00012927
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this drug study is to find out whether the antibiotic lefamulin (trade name Xenleta) will cure Mycoplasma genitalium infections that have not been cured by prior antibiotics while finding out whether it is more effective if the antibiotic doxycycline is taken first.

Conditions

Mycoplasma Genitalium Infection

Keywords

Lefamulin; Doxycycline; M. genitalium

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Participants With Microbiologic Cure

  Defined as a negative Aptima Mycoplasma genitalium test 21-28 days after completion of the lefamulin

  21-28 days after completion of the lefamulin

Secondary Outcomes (1)

• Number and Percentage of Participants With Sustained Microbiologic Cure

  42-47 days after completion of the lefamulin

Study Arms (2)

Lefamulin alone

EXPERIMENTAL

Lefamulin 600mg tablet orally twice daily for 7 days

Drug: Lefamulin

Doxycycline followed by lefamulin

EXPERIMENTAL

Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days

Drug: Lefamulin; Drug: Doxycycline

Interventions

Lefamulin DRUG

600mg tablet orally twice daily

Also known as: Xenleta

Doxycycline followed by lefamulin; Lefamulin alone

Doxycycline DRUG

100mg tablet orally twice daily

Doxycycline followed by lefamulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician referral
• Persistent symptomatic urogenital M. genitalium infection documented by any nucleic acid amplification test (NAAT) 14-90 days after completion of the prior antimicrobial regimen for M. genitalium
• Low risk of reinfection, defined as no unprotected sex with an untreated sex partner since completion of the prior antimicrobial regimen for M. genitalium
• Living in the United States
• Male or female sex at birth
• At least 18 years of age
• English-speaking
• Able to provide written informed consent
• Able to undergo a test to confirm M. genitalium infection at baseline and tests of cure 21-28 days and 42-47 days after completion of the lefamulin
• Referring physician willing and able to provide needed patient information

You may not qualify if:

• Rectal M. genitalium infection only
• Females with pelvic inflammatory disease (PID), pregnancy, or currently breastfeeding
• Females of reproductive age not on a highly effective method of contraception (i.e., intrauterine device (IUD), Nexplanon, progesterone only depot injection with last injection less than three months prior, oral contraceptive pill and last menstrual period less than 28 days prior)
• Known QT prolongation or ventricular arrhythmias including torsades de pointes
• Receiving concurrent drugs known to prolong QT interval (i.e., Class IA or III antiarrhythmics, antipsychotics, erythromycin, pimozide, moxifloxacin, tricyclic antidepressants)
• Receiving strong or moderate CYP3A or P-gp inducers, strong CYP3A or P-gp inhibitors, moderate CYP3A or P-gp inhibitors, or sensitive CYP3A4 substrates that prolong QT interval
• Moderate or severe liver impairment
• Known liver disease
• Renal failure requiring dialysis
• Known allergy to doxycycline, other tetracyclines, and/or lefamulin
• Unwilling or unable to undergo a test to confirm M. genitalium infection at baseline or tests of cure 21-28 days and 42-47 days after completion of the lefamulin
• Not fluent in English and/or not able to provide written informed consent
• Referring physician unwilling or unable to provide needed patient information
• At the study physician's discretion

Sponsors & Collaborators

• University of Washington: lead
• Nabriva Therapeutics AG: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Interventions

lefamulin; Doxycycline

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

This trial was stopped early due to cessation of operations by the antibiotic manufacturer and expiration of study drug. The number of study participants was less than designed and the small number of people resulted in unstable efficacy estimates and wide 95% confidence intervals.

Results Point of Contact

• Title: Lisa E Manhart
• Organization: University of Washington

lmanhart@uw.edu

206-744-3646

Study Officials

• Lisa E Manhart, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Epidemiology

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: April 22, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: October 26, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)