Trial Outcomes & Findings for Lefamulin for M. Genitalium Treatment Failures (NCT NCT05111002)

NCT ID: NCT05111002

Last Updated: 2024-10-26

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 21-28 days after completion of the lefamulin
• Results posted on: 2024-10-26

Participant Flow

Participant milestones

Measure	Lefamulin Alone Lefamulin 600mg tablet orally twice daily for 7 days	Doxycycline Followed by Lefamulin Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days
Primary Outcome STARTED	6	6
Primary Outcome COMPLETED	5	6
Primary Outcome NOT COMPLETED	1	0
Secondary Outcome STARTED	5	6
Secondary Outcome COMPLETED	4	6
Secondary Outcome NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Lefamulin Alone Lefamulin 600mg tablet orally twice daily for 7 days	Doxycycline Followed by Lefamulin Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days
Primary Outcome Negative Confirmatory Aptima MG Test	1	0
Secondary Outcome Lost to Follow-up	1	0

Baseline Characteristics

Lefamulin for M. Genitalium Treatment Failures

Baseline characteristics by cohort

Measure	Lefamulin Alone n=6 Participants Lefamulin 600mg tablet orally twice daily for 7 days	Doxycycline Followed by Lefamulin n=6 Participants Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days	Total n=12 Participants Total of all reporting groups
Age, Continuous	37 years n=5 Participants	40 years n=7 Participants	39 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Confirmatory MG Test Positive	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Confirmatory MG Test Negative	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Confirmatory MG Test Indeterminate	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 21-28 days after completion of the lefamulin

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

Outcome measures

Measure	Lefamulin Alone n=5 Participants Lefamulin 600mg tablet orally twice daily for 7 days	Doxycycline Followed by Lefamulin n=6 Participants Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days
Number and Percentage of Participants With Microbiologic Cure	60 percentage of participants Interval 15.0 to 95.0	50 percentage of participants Interval 12.0 to 88.0

SECONDARY outcome

Timeframe: 42-47 days after completion of the lefamulin

Defined as a negative Aptima Mycoplasma genitalium test 42-47 days after completion of the lefamulin

Outcome measures

Measure	Lefamulin Alone n=4 Participants Lefamulin 600mg tablet orally twice daily for 7 days	Doxycycline Followed by Lefamulin n=6 Participants Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days
Number and Percentage of Participants With Sustained Microbiologic Cure	50 percentage of participants Interval 7.0 to 93.0	50 percentage of participants Interval 12.0 to 88.0

Adverse Events

Lefamulin Alone

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Doxycycline Followed by Lefamulin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lefamulin Alone n=5 participants at risk Lefamulin 600mg tablet orally twice daily for 7 days	Doxycycline Followed by Lefamulin n=6 participants at risk Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days
Gastrointestinal disorders Nausea	80.0% 4/5 • 10 months	50.0% 3/6 • 10 months
Gastrointestinal disorders Vomiting	0.00% 0/5 • 10 months	0.00% 0/6 • 10 months
Gastrointestinal disorders Diarrhea	100.0% 5/5 • 10 months	66.7% 4/6 • 10 months
Skin and subcutaneous tissue disorders Sensitivity to Light	— 0/0 • 10 months	16.7% 1/6 • 10 months
Infections and infestations Vaginal Yeast Infection	— 0/0 • 10 months	0.00% 0/6 • 10 months
General disorders Other	20.0% 1/5 • 10 months	50.0% 3/6 • 10 months

Additional Information

Lisa E Manhart

University of Washington

Phone: 206-744-3646

Email: lmanhart@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place