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NCT05133752 Clinical Trial

Oral Nemonoxacin in Treating Elderly Patients With CAP

Community-acquired Pneumonia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05133752
Other study ID # TG-873870-05
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 11, 2018
Est. completion date March 23, 2020

Study information
Verified date November 2021
Source TaiGen Biotechnology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 23, 2020
Est. primary completion date March 23, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Taiwan Tri-Service General Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
TaiGen Biotechnology Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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)
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