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A Phase II study of T-4288 in patients with community-acquired pneumonia

A Phase II, multi-center, randomized, double-blind study of T-4288 in patients with community-acquired pneumonia

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222672
Enrollment
Unknown
Registered
2014-11-27
Start date
2014-11-27
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 2. Gender : Both 3. Confirmed clear infiltrative shadow by chest X-ray or CT within 48 hours prior to the first administration of the study drug 4. Confirmed at least one of the following changes in laboratory values; -WBC increased (WBC > 10000 /mm3) -Stab cell > 15% -WBC decreased (WBC < 4500 /mm3) 5. Confirmed at least one of the following clinical symptoms and/or findings: -Cough -Abnormal findings on auscultation and/or percussion -Dyspnea or tachypnea -Hypoxemia 6. 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, safety and pharmacokinetic profile—

Outcome results

None listed

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