Lefamulin for M. Genitalium Treatment Failures (NCT05111002) | Clinical Trial Compass
TerminatedPhase 1/2
Lefamulin for M. Genitalium Treatment Failures
Stopped: At Sponsor Request
United States12 participantsStarted 2022-04-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 CYP3…
What they're measuring
1
Number and Percentage of Participants With Microbiologic Cure
Timeframe: 21-28 days after completion of the lefamulin