Lefamulin Post-Market Surveillance in Community-Acquired Pneumonia
Official title: A Multicenter, Single-arm, Real-world Study to Evaluate the Safety and Efficacy of Lefamulin in Patients With Community-acquired Pneumonia
Run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. · NCT07697885 · Data updated 2026-11-12
This study follows people with community-acquired pneumonia who are being treated with lefamulin to see how it works in real-world clinical use.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Marubeni Pharmaceuticals (Suzhou) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 30, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT07697885 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults diagnosed with CAP who are currently receiving lefamulin or are to begin lefamulin therapy as determined by their treating physician.
✕Probably not a fit
Patients with contraindications to lefamulin or those not treated with lefamulin would not be expected to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, single-arm observational study collects real-world data on lefamulin use for community-acquired pneumonia in China. No new treatments are given as part of the study; patients are treated per routine clinical practice. Researchers will document outcomes, safety events, and patterns of lefamulin use across participating centers. The goal is to understand effectiveness and safety outside controlled trials and to inform future prescribing. The study is sponsored by Marubeni Pharmaceuticals with collaboration from China-Japan Friendship Hospital.
Why it matters
Potential benefit: If successful, findings could improve understanding of lefamulin's safety and effectiveness for CAP in real-world settings.
How similar studies have gone: Prior real-world and post-market data for lefamulin have shown useful safety and usage patterns in practice settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed informed consent form 2. Clinical diagnosis of community-acquired pneumonia (CAP) by treating physicians 3. Currently receiving lefamulin treatment or prescribed and agreed to initiate lefamulin therapy as determined by the treating physician Exclusion Criteria: 1. Patients with contraindications to lefamulin according to the approved prescribing information (e.g., known hypersensitivity to lefamulin or pleuromutilin class antibiotics) 2. Pulmonary infiltrates caused by non-infectious factors (e.g., pulmonary embolism, aspiration chemical pneumonitis, hypersensitivity pneumonitis, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis) 3. Confirmed or suspected empyema via chest X-ray or CT examination 4. Participation in any other ongoing interventional clinical trial
Where it's running
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.