Clinical Trials Logo
  1. Home
  2. Community-Acquired Pneumonia
  3. NCT05133752
  4. Details
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)
See also
  Status Clinical Trial Phase
Recruiting NCT05722938 - Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) Phase 3
Terminated NCT04972318 - Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia N/A
Recruiting NCT06065618 - Characteristics of Hospitalized Patients With Community-acquired Pneumonia
Not yet recruiting NCT03675178 - Clinical Study of Anerning Particle for the Treatment of Childhood Community-acquired Pneumonia Phase 4
Not yet recruiting NCT04166110 - Antibiotic Therapy In Respiratory Tract Infections N/A
Completed NCT02380352 - Short-course Antimicrobial Therapy for Paediatric Respiratory Infections Phase 4
Completed NCT01671280 - Drug Use Investigation Of Azithromycin IV For Community-Acquired Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan) N/A
Completed NCT02555852 - Proton Pump Inhibitors and Risk of Community-acquired Pneumonia N/A
Recruiting NCT00752947 - Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors Phase 4
Completed NCT00140023 - Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia Phase 3
Recruiting NCT04089787 - Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia Phase 4
Completed NCT05356494 - Postural Drainage and PEP Technique in Community Acquired Pneumonia N/A
Not yet recruiting NCT06291012 - Stopping Pneumonia Antibiotherapy Regimen Early Phase 4
Recruiting NCT05002192 - A Retrospective, Real-world Study of ELP Used in the Expectorant Treatment of Community-acquired Pneumonia
Completed NCT03452826 - Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia N/A
Terminated NCT04071041 - Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia. Phase 3
Completed NCT03474991 - KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP Phase 3
Completed NCT01723644 - Clinical Reassessment Versus Procalcitonin in Order to Shorten Antibiotic Duration in Community-acquired Pneumonia N/A
Withdrawn NCT01662258 - Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP N/A
Completed NCT01683487 - Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia. Phase 4