Back to resultsOral Nemonoxacin in Treating Elderly Patients With CAP
Primary Purpose
Community-acquired Pneumonia
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Nemonoxacin
Sponsored by
About this trial
This is an interventional treatment trial for Community-acquired Pneumonia
Eligibility Criteria
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
Sites / Locations
- Tri-Service General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nemonoxacin
Arm Description
Outcomes
Primary Outcome 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
Secondary Outcome Measures
Number of participants with clinical success in the modified intention-to-treat (mITT) population, intention-to-treat (ITT), and clinically evaluable (CE) populations.
Full Information
NCT ID
NCT05133752
First Posted
November 8, 2021
Last Updated
November 15, 2021
Sponsor
TaiGen Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05133752
Brief Title
Oral Nemonoxacin in Treating Elderly Patients With CAP
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TaiGen Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nemonoxacin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nemonoxacin
Intervention Description
500 mg, oral administration, once daily for 7-10 days.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Oral Nemonoxacin in Treating Elderly Patients With CAP
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