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: 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
- Drug: Nemonoxacin
- 500 mg, oral administration, once daily for 7-10 days.
Arms, Groups and Cohorts
- Experimental: Nemonoxacin
Clinical Trial 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
- Time Frame: From Visit 1 (Baseline) till Visit 3 (within 24 hr after last dose)
- 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
- 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
- Lead Sponsor
- TaiGen Biotechnology Co., Ltd.
- Provider of Information About this Clinical Study
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.