Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT05111002
Status:
TERMINATED
Last Update Posted:
2024-10-26
First Post:
2021-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Lefamulin for M. Genitalium Treatment Failures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591018', 'term': 'lefamulin'}, {'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lmanhart@uw.edu', 'phone': '206-744-3646', 'title': 'Lisa E Manhart', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '10 months', 'eventGroups': [{'id': 'EG000', 'title': 'Lefamulin Alone', 'description': 'Lefamulin 600mg tablet orally twice daily for 7 days', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Doxycycline Followed by Lefamulin', 'description': 'Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sensitivity to Light', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal Yeast Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number and Percentage of Participants With Microbiologic Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lefamulin Alone', 'description': 'Lefamulin 600mg tablet orally twice daily for 7 days'}, {'id': 'OG001', 'title': 'Doxycycline Followed by Lefamulin', 'description': 'Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '95'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21-28 days after completion of the lefamulin', 'description': 'Defined as a negative Aptima Mycoplasma genitalium test 21-28 days after completion of the lefamulin', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Participants With Sustained Microbiologic Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lefamulin Alone', 'description': 'Lefamulin 600mg tablet orally twice daily for 7 days'}, {'id': 'OG001', 'title': 'Doxycycline Followed by Lefamulin', 'description': 'Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '93'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '42-47 days after completion of the lefamulin', 'description': 'Defined as a negative Aptima Mycoplasma genitalium test 42-47 days after completion of the lefamulin', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lefamulin Alone', 'description': 'Lefamulin 600mg tablet orally twice daily for 7 days'}, {'id': 'FG001', 'title': 'Doxycycline Followed by Lefamulin', 'description': 'Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days'}], 'periods': [{'title': 'Primary Outcome', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Negative Confirmatory Aptima MG Test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Secondary Outcome', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lefamulin Alone', 'description': 'Lefamulin 600mg tablet orally twice daily for 7 days'}, {'id': 'BG001', 'title': 'Doxycycline Followed by Lefamulin', 'description': 'Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '39'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '34', 'upperLimit': '44'}, {'value': '39', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '43'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Confirmatory MG Test', 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Confirmatory Aptima Mycoplasma genitalium test', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-03', 'size': 246980, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-28T15:22', 'hasProtocol': True}, {'date': '2022-08-24', 'size': 187491, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-28T15:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'At Sponsor Request', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2021-10-27', 'resultsFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2021-10-27', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-23', 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and Percentage of Participants With Microbiologic Cure', 'timeFrame': '21-28 days after completion of the lefamulin', 'description': 'Defined as a negative Aptima Mycoplasma genitalium test 21-28 days after completion of the lefamulin'}], 'secondaryOutcomes': [{'measure': 'Number and Percentage of Participants With Sustained Microbiologic Cure', 'timeFrame': '42-47 days after completion of the lefamulin', 'description': 'Defined as a negative Aptima Mycoplasma genitalium test 42-47 days after completion of the lefamulin'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lefamulin', 'Doxycycline', 'M. genitalium'], 'conditions': ['Mycoplasma Genitalium Infection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Study participants will be randomly chosen to receive either lefamulin alone or doxycycline followed by lefamulin in a 1:1 ratio. Each participant will receive 14 lefamulin pills or 14 doxycycline pills and 14 lefamulin pills in the mail and take them as directed for one week (each). Participants will collect one culture sample and one sample to confirm M. genitalium infection on the same day they take their first pill then mail the two samples to the laboratory. They will also answer questions about their symptoms, any side effects, and their behavior with their sex partners. Participants will collect samples two more times and answer questions three more times if they are randomly chosen to receive lefamulin alone or four more times if they are randomly chosen to receive doxycycline followed by lefamulin during the study. The study team will culture M. genitalium then determine minimum inhibitory concentrations (MICs) to three antibiotics (azithromycin, moxifloxacin, and lefamulin) to see whether it is resistant to any of these antibiotics. The study team will also test for M. genitalium to confirm whether the participants have an infection at baseline and see if lefamulin cured the infection upon completion of the lefamulin.\n\nAfter 20 patients have been enrolled, the study team will conduct an interim analysis to assess futility. Futility will be defined as less than five percent probability that true efficacy is greater than or equal to 60 percent (i.e., less than or equal to three of the first 10 participants experience microbiologic cure). If neither lefamulin alone nor doxycycline followed by lefamulin meets criteria for futility, the study team will continue the study. If one regimen meets criteria for futility, the study team will drop the regimen that met the criteria for futility and continue to administer the other regimen to the remaining 20 participants. If both regimens meet criteria for futility, the study team will halt the study.\n\nStudy participants will be informed of their M. genitalium test of cure results. If the lefamulin does not cure the infection, the study physician will consult with the referring physician who will continue to treat the infection per clinic standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Physician referral\n* 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\n* Low risk of reinfection, defined as no unprotected sex with an untreated sex partner since completion of the prior antimicrobial regimen for M. genitalium\n* Living in the United States\n* Male or female sex at birth\n* At least 18 years of age\n* English-speaking\n* Able to provide written informed consent\n* 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\n* Referring physician willing and able to provide needed patient information\n\nExclusion Criteria:\n\n* Rectal M. genitalium infection only\n* Females with pelvic inflammatory disease (PID), pregnancy, or currently breastfeeding\n* 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)\n* Known QT prolongation or ventricular arrhythmias including torsades de pointes\n* Receiving concurrent drugs known to prolong QT interval (i.e., Class IA or III antiarrhythmics, antipsychotics, erythromycin, pimozide, moxifloxacin, tricyclic antidepressants)\n* 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\n* Moderate or severe liver impairment\n* Known liver disease\n* Renal failure requiring dialysis\n* Known allergy to doxycycline, other tetracyclines, and/or lefamulin\n* 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\n* Not fluent in English and/or not able to provide written informed consent\n* Referring physician unwilling or unable to provide needed patient information\n* At the study physician's discretion"}, 'identificationModule': {'nctId': 'NCT05111002', 'briefTitle': 'Lefamulin for M. Genitalium Treatment Failures', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Lefamulin for Mycoplasma Genitalium Treatment Failures in the US', 'orgStudyIdInfo': {'id': 'STUDY00012927'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lefamulin alone', 'description': 'Lefamulin 600mg tablet orally twice daily for 7 days', 'interventionNames': ['Drug: Lefamulin']}, {'type': 'EXPERIMENTAL', 'label': 'Doxycycline followed by lefamulin', 'description': 'Doxycycline 100mg tablet orally twice daily for 7 days followed by lefamulin 600mg tablet orally twice daily for 7 days', 'interventionNames': ['Drug: Lefamulin', 'Drug: Doxycycline']}], 'interventions': [{'name': 'Lefamulin', 'type': 'DRUG', 'otherNames': ['Xenleta'], 'description': '600mg tablet orally twice daily', 'armGroupLabels': ['Doxycycline followed by lefamulin', 'Lefamulin alone']}, {'name': 'Doxycycline', 'type': 'DRUG', 'description': '100mg tablet orally twice daily', 'armGroupLabels': ['Doxycycline followed by lefamulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Lisa E Manhart, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not federally funded. Currently no IPD sharing plan.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nabriva Therapeutics AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Epidemiology', 'investigatorFullName': 'Lisa Manhart', 'investigatorAffiliation': 'University of Washington'}}}}