NCT05133752

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

November 8, 2021

Last Update Submit

November 15, 2021

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (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 Outcomes (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)

Study Arms (1)

Nemonoxacin

EXPERIMENTAL
Drug: Nemonoxacin

Interventions

NemonoxacinDRUG

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

Nemonoxacin

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥65 years
  • Clinical diagnosis of CAP
  • Evidence of inflammatory exudates or infiltrates on chest X-ray

You may not qualify if:

  • Suspect viral pneumonia, aspiration pneumonia, ventilator-associated pneumonia or hospital-acquired pneumonia
  • History of hypersensitivity to quinolone or fluoroquinolone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

nemonoxacin

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 24, 2021

Study Start

September 11, 2018

Primary Completion

March 23, 2020

Study Completion

March 23, 2020

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations

TW(1)