Methicillin-susceptible S. Aureus (MSSA)NCT06959667
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
An observational study of Methicillin-susceptible S. Aureus (MSSA) and Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Methicillin-susceptible S. Aureus (MSSA), Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA), Complicated Skin and Soft Tissue,cSSTI
- How many people
- 144 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: complicated skin and soft tissue (cSSTI) infection
Who may be able to join
- complicated skin and soft tissue (cSSTI) infection
Who cannot join
- no complicated skin and soft tissue (cSSTI) infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
Nemonoxacin 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.
- Conditions
- Methicillin-susceptible S. Aureus (MSSA), Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA), Complicated Skin and Soft Tissue,cSSTI
- Being tested
- Observational study, no intervention
- Keywords
- methicillin-susceptible S. aureus (MSSA), Nemonoxacin, anti-methicillin resistant Staphylococcus aureus (anti-MRSA), complicated skin and soft tissue,cSSTI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, no interventionOther
Observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Use other antimicrobial therapy (vancomycin, teicoplanin, daptomycin, linezolid, or other anti-MRSA | Use other antimicrobial therapy (vancomycin, teicoplanin, daptomycin, linezolid, or other anti-MRSA antibiotics) | |
| Use Nemonoxacin | Use Nemonoxacin Receives: Other: Observational study, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between 01 January 2023 and 31 January 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start15 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin-susceptible S. Aureus (MSSA)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959667
- Sponsor's protocol ID
- 202502099RIND
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06959667
- Acronym / sponsor ID
- 202502099RIND
- Conditions
- Methicillin-susceptible S. Aureus (MSSA), Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA), Complicated Skin and Soft Tissue,cSSTI
- Keywords
- methicillin-susceptible S. aureus (MSSA), Nemonoxacin, anti-methicillin resistant Staphylococcus aureus (anti-MRSA), complicated skin and soft tissue,cSSTI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Nemonoxacin 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use other antimicrobial therapy (vancomycin, teicoplanin, daptomycin, linezolid, or other anti-MRSA | – | –Use other antimicrobial therapy (vancomycin, teicoplanin, daptomycin, linezolid, or other anti-MRSA antibiotics) |
| Use Nemonoxacin | – | Other: Observational study, no interventionUse Nemonoxacin |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- complicated skin and soft tissue (cSSTI) infection
Key inclusion criteria (1 listed)
- complicated skin and soft tissue (cSSTI) infection
Key exclusion criteria (1 listed)
- no complicated skin and soft tissue (cSSTI) infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, no interventionObservational study, no intervention | Other | Use Nemonoxacin |
Primary outcome
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.
Time frame: between 01 January 2023 and 31 January 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methicillin-susceptible S. Aureus (MSSA) and Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA), run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: between 01 January 2023 and 31 January 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.