Oral Nemonoxacin in Treating Elderly Patients With CAP

Phase 4

Completed

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: Nemonoxacin

• Registration Number: NCT05133752
• Lead Sponsor: TaiGen Biotechnology Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-11
• Primary Completion: 2020-03-23
• Study Completion: 2020-03-23
• Status Verified: 2021-11
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-15
• Last Update Submitted: 2021-11-15
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nemonoxacin	Nemonoxacin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan