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OpenTrials
Completed

NCT Number: NCT05133752

Oral Nemonoxacin in Treating Elderly Patients With CAP

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

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Key information

Conditions

Community-Acquired Pneumonia Community-Acquired Infections Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tri-Service General Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nemonoxacin

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

TaiGen Biotechnology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 24, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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