Oral Nemonoxacin in Treating Elderly Patients With CAP

• Sponsor: TaiGen Biotechnology Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05133752
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Actual Duration (Months): 18.4
• Patients Per Site Per Month: 5.4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia	Drug: Nemonoxacin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 11, 2018
• Actual Primary Completion Date: Mar 23, 2020
• Actual Study Completion Date: Mar 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nemonoxacin	Drug: Nemonoxacin; 500 mg, oral administration, once daily for 7-10 days.

Outcome Measures

Primary Outcome Measures

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 [From Visit 1 (Baseline) till Visit 3 (within 24 hr after last dose)]

Secondary Outcome Measures

1. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tri-Service General Hospital	Taipei		Taiwan

Sponsors and Collaborators

• TaiGen Biotechnology Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TaiGen Biotechnology Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05133752
• Other Study ID Numbers: TG-873870-05
• First Posted: Nov 24, 2021
• Last Update Posted: Nov 24, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia

Study Results

No Results Posted as of Nov 24, 2021