A Phase III , open-label study of KRP-AM1977Y in respiratory tract infectio
Phase 3
Completed
- Conditions
- Secondary infection of chronic respiratory disease , aspiration pneumonia and Lung abscess
- Registration Number
- JPRN-jRCT2080223247
- Lead Sponsor
- Kyorin Pharmaceutical Co.,LTD
- Brief Summary
KRP-AM1977Y was highly effective for Secondary infection of chronic respiratory disease, Aspiration pneumonia, and Lung abscess. In the safety assessment, no clinically significant finding was reported in KRP-AM1977Y.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
Respiratory tract infection with clear infection symptoms
Exclusion Criteria
Patient with hypersensitivity to quinolone antibacterial agent
Patient with serious functional disorder that would unsuitable for the study
Patient showing the tendency to improve pneumonia symptoms by other agents
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Secondary infection of chronic respiratory disease: Clinical efficacy at test of cure<br>Aspiration pneumonia and Lung abscess: Clinical efficacy at end of treatment<br>Assessment of clinical response by comparing the clinical findings
- Secondary Outcome Measures
Name Time Method efficacy<br>Secondary infection of chronic respiratory disease: Clinical efficacy at end of treatment,etc.<br>Aspiration pneumonia and Lung abscess: Clinical efficacy at Day 3,etc.<br>Assessment of clinical response by comparing the clinical findings