Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-26 @ 5:52 AM
Study NCT ID:
NCT06959667
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-06
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis of Nemonoxacin and Other Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA) Antimicrobial Therapy in Patients With Complicated Skin and Soft Tissue Infections (cSSTI): a Retrospective Chart Review Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the clinical outcome of intravenous/oral nemonoxacin therapy compared with other antimicrobial therapy (vancomycin, teicoplanin, daptomycin, linezolid, or other anti-MRSA antibiotics) in patients with cSSTI.', 'timeFrame': 'between 01 January 2023 and 31 January 2025'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['methicillin-susceptible S. aureus (MSSA)', 'Nemonoxacin', 'anti-methicillin resistant Staphylococcus aureus (anti-MRSA)', 'complicated skin and soft tissue,cSSTI'], 'conditions': ['Methicillin-susceptible S. Aureus (MSSA)', 'Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA)', 'Complicated Skin and Soft Tissue,cSSTI']}, 'descriptionModule': {'briefSummary': 'Increasing rates of antimicrobial resistant bacterial infections and antimicrobial therapy at home in elderly are great concern for medical care. The availability of new antibacterial agents that are effective against bacteria with resistance to other antibacterials is therefore critical to continued successful management of bacterial illnesses in the future. Nemonoxacin is a C-8 methoxy, non-fluorinated quinolone that retains potent broad-spectrum activities against Gram-positive and Gram-negative bacteria by selective inhibition of bacterial DNA topoisomerase.\n\nNemonoxacin had greater in-vitro activity against many Gram-positive bacteria, including methicillin-susceptible S. aureus (MSSA), and ciprofloxacin-susceptible and ciprofloxacin-resistant MRSA, levofloxacin-susceptible and levofloxacin-resistant S. pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, enterococci, and Enterobacterieacea species except Pseudomonas aeruginosa. Lowe selected mutation of Nemonoxacin, compared with other fluoroquinolones against antimicrobial resistant gram-positive bacteria had been reported.\\[5\\] Nemonoxacin could be used once-daily oral and intravenous formulations for the treatment of community-acquired pneumonia, including methicillin resistant Staphylococcus aureus (MRSA). However, nemonoxacin has less evidence of efficacy for complicated skin and soft tissue infection. In this retrospective study, we will investigate the treatment outcomes of nemonoxacin and compared with other anti-methicillin resistant Staphylococcus aureus (anti-MRSA) antimicrobial therapy in patients with complicated skin and soft tissue infections (cSSTI) by chart review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'complicated skin and soft tissue (cSSTI) infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complicated skin and soft tissue (cSSTI) infection\n\nExclusion Criteria:\n\n* no complicated skin and soft tissue (cSSTI) infection'}, 'identificationModule': {'nctId': 'NCT06959667', 'briefTitle': 'Comparative Analysis of Nemonoxacin and Other Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA) Antimicrobial Therapy in Patients With Complicated Skin and Soft Tissue Infections (cSSTI): a Retrospective Chart Review Study', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comparative Analysis of Nemonoxacin and Other Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA) Antimicrobial Therapy in Patients With Complicated Skin and Soft Tissue Infections (cSSTI): a Retrospective Chart Review Study', 'orgStudyIdInfo': {'id': '202502099RIND'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Use other antimicrobial therapy (vancomycin, teicoplanin, daptomycin, linezolid, or other anti-MRSA', 'description': 'Use other antimicrobial therapy (vancomycin, teicoplanin, daptomycin, linezolid, or other anti-MRSA antibiotics)'}, {'label': 'Use Nemonoxacin', 'description': 'Use Nemonoxacin', 'interventionNames': ['Other: Observational study, no intervention']}], 'interventions': [{'name': 'Observational study, no intervention', 'type': 'OTHER', 'description': 'Observational study, no intervention', 'armGroupLabels': ['Use Nemonoxacin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'NTUH', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'To compare the clinical efficacy, antimicrobial efficacy, and adverse drug reactions of nemonoxacin in the treatment of complicated skin and soft tissue infections (cSSTIs) with other anti-MRSA antimicrobial therapies in patients with complicated skin and soft tissue infections.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'WANG-HUEI SHENG', 'investigatorFullName': 'National Taiwan University Clinical Trial Center', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}