Efficacy and safety of oral solithromycin versus oral azithromycin in the treatment of community-acquired pneumonia
- Conditions
- Community-acquired pneumonia
- Registration Number
- JPRN-jRCT2080224917
- Lead Sponsor
- FUJIFILM Toyama Chemical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 506
1. Age: 18 years or older (at the time of obtaining informed consent)
2. Sex : Irrespective
3. Outpatient/hospitalization: Irrespective
4. Patients with no history of hospitalization within 2 weeks before the development of pneumonia, or no history of hospitalization in a long-term care institution
5. Patients with newly developed infiltrative shadow on either chest X-ray imaging or computed tomography (CT) imaging taken within 48 hours before the start of study drug administration
6. Patients from whom written informed consent can be obtained from the patients themselves
7. Others
1. Patients with symptoms which are showing improvement by having received systemic oral antibacterial drugs
2. Patients with a history of allergy to macrolides or ketolides
3. Others
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response at TOC
- Secondary Outcome Measures
Name Time Method Clinical response at Day 4 and Day 8<br>Microbiological response at Day 4, Day 8 and TOC