Oral Nemonoxacin in Treating Elderly Patients With CAP

TaiGen Biotechnology Co., Ltd.100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Community-acquired Pneumonia

Interventions

NemonoxacinDRUG

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Tri-Service General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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

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)

Data from ClinicalTrials.gov

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