Lefamulin for M. Genitalium Treatment Failures

• Status: Not yet recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: Nabriva Therapeutics AG
• Treatments: Doxycycline; Lefamulin

Criteria

Inclusion Criteria:

• Physician referral

• Persistent symptomatic M. genitalium infection documented by a 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

• 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 of cure 21-28 days and 42-47 days after completion of the lefamulin

• Referring physician willing to complete case report form and supplementary data collection form

Exclusion Criteria:

• 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 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 and/or lefamulin

• Not willing or not able to undergo a test 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 not willing or not able to complete case report form and supplementary data collection form

• At the study physician's discretion, potential participant does not understand the risks and benefits and/or is not able to complete all study procedures