NCT06959667

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 6, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

April 28, 2025

Last Update Submit

April 28, 2025

Conditions

Keywords

methicillin-susceptible S. aureus (MSSA)Nemonoxacinanti-methicillin resistant Staphylococcus aureus (anti-MRSA)complicated skin and soft tissue,cSSTI

Outcome Measures

Primary Outcomes (1)

  • 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.

    between 01 January 2023 and 31 January 2025

Study Arms (2)

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

Other: Observational study, no intervention

Interventions

Observational study, no intervention

Use Nemonoxacin

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

complicated skin and soft tissue (cSSTI) infection

You may qualify if:

  • complicated skin and soft tissue (cSSTI) infection

You may not qualify if:

  • no complicated skin and soft tissue (cSSTI) infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTUH

Taipei, Taiwan

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
WANG-HUEI SHENG

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 6, 2025

Study Start

April 15, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL

Locations