Oral Nemonoxacin in Treating Elderly Patients With CAP

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 23, 2020

Interventions

  • Drug: Nemonoxacin
    • 500 mg, oral administration, once daily for 7-10 days.

Arms, Groups and Cohorts

  • Experimental: Nemonoxacin

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: From Visit 1 (Baseline) till Visit 3 (within 24 hr after last dose)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • TaiGen Biotechnology Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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