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A Phase III study of Solithromycin in patients with community-acquired pneumonia

A Phase III, multi-center, randomized, double-blind, non-inferiority study of Solithromycin versus Levofloxacin in patients with community-acquired pneumonia

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223384
Enrollment
Unknown
Registered
2016-11-17
Start date
2016-11-17
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 : T-4288 INN of investigational material : Solithromycin Therapeutic category code : 614 Antibiotic preparations acting mainly on gram-positive bacteria an

Sponsors

Toyama Chemical Co., Ltd.(Current FUJIFILM Toyama Chemical Co., Ltd.)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age: 20 years of age and older (at the time of obtaining informed consents) 2.Gender : Both 3.Inpatient/Outpatient status: Either 4.No history of hospitalization or hospitalization in a long-term care facility within 2 weeks before the onset of pneumonia 5.Confirmed clear infiltrative shadow by chest X-ray or CT within 48 hours prior to the first administration of the study drug 6.Signed the informed consent form by patients or patients' legal representatives 7.Others

Exclusion criteria

Exclusion criteria: 1.Having improvement of clinical symptoms due to pneumonia by other systemic antibiotics 2.Having a history of allergy to macrolide or quinolone antibiotics 3.Others

Design outcomes

Primary

MeasureTime frame
Efficacy and safety profile—

Outcome results

None listed

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