Efficacy and safety of oral solithromycin versus oral azithromycin in the treatment of community-acquired pneumonia

A Phase 3, Multicenter, Randomized, Double-Blind Noninferiority Study of Oral Solithromycin Compared to Oral Azithromycin in the Treatment of Patients with Community-Acquired Pneumonia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224917

Enrollment

506

Registered

2019-10-16

Start date

2019-10-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired pneumonia

Interventions

investigational material(s) Generic name etc : Solithromycin INN of investigational material : Solithromycin Therapeutic category code : 614 Antibiotic preparations acting mainly on gram-positive bact

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Clinical response at TOC	—

Secondary

Measure	Time frame
Clinical response at Day 4 and Day 8 Microbiological response at Day 4, Day 8 and TOC	—

Countries

Japan

Contacts

Public ContactOfficer Clinical Trial Information

FUJIFILM Toyama Chemical Co., Ltd.

fftc-clinicaltrial-info1@fujifilm.com+81-3-6228-3129

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026