Phase III study of Garenoxacin in the treatment of community-acquired pneumonia- A randomized, multi-center, double-blind, double-dummy and comparative study
Phase 3
- Conditions
- The patients with community-acquired pneumonia
- Registration Number
- JPRN-jRCT2080221655
- Lead Sponsor
- Toyama Chemical Co., Ltd.(Current FUJIFILM Toyama Chemical Co., Ltd.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
(1) Patients with community-acquired pneumonia requiring outpatient or inpatient treatment.
(2) Sex: male or female.
(3) Age: 18 to 70 years old.
(4) Pneumonia patients indicated to oral antibacterial agents.
(5) Others.
Exclusion Criteria
(1)History of hypersensitive reaction to any quinolone antibacterial agents.
(2) History of twitch and/or epilepsia or taking antiepileptic agents.
(3) Pregnant females, females wishing to become pregnant or being possibly pregnant, and lactating females.
(4) Patients with severe infection requiring tretment with injectable antibacterial agents or mechanical ventilator.
(5) Others.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical efficacy, bacteriological responses and safety<br>Clinical efficacy, bacteriological responses and safety
- Secondary Outcome Measures
Name Time Method