Oral Nemonoxacin in Treating Elderly Patients With CAP

A Multi-Center, Open-Label, Single-Arm, Phase IV Study to Evaluate the Safety and Clinical Efficacy of Oral Administration With Nemonoxacin in Treating Elderly Patients With Community-Acquired Pneumonia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05133752

Enrollment

100

Registered

2021-11-24

Start date

2018-09-11

Completion date

2020-03-23

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

Brief summary

This study was to evaluate the safety and efficacy of oral nemonoxacin in treating elderly patients (aged ≥ 65 years) with community-acquired pneumonia (CAP).

Interventions

DRUGNemonoxacin

500 mg, oral administration, once daily for 7-10 days.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥65 years * Clinical diagnosis of CAP * Evidence of inflammatory exudates or infiltrates on chest X-ray

Exclusion criteria

* Suspect viral pneumonia, aspiration pneumonia, ventilator-associated pneumonia or hospital-acquired pneumonia * History of hypersensitivity to quinolone or fluoroquinolone

Design outcomes

Primary

Measure	Time frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after treatment with oral nemonoxacin once daily for 7-10 days	From Visit 1 (Baseline) till Visit 3 (within 24 hr after last dose)

Secondary

Measure	Time frame
Number of participants with clinical success in the modified intention-to-treat (mITT) population, intention-to-treat (ITT), and clinically evaluable (CE) populations.	Visit 3 (within 24 hr after last dose)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026