Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT05111002
Eligibility Criteria:
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05111002
Study Brief:
Protocol Section:
NCT05111002