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Lefamulin Post-Market Surveillance Study

Recruitingn/aAges any - anyAllMarubeni Pharmaceuticals (Suzhou) Co., Ltd.
NCT07697885 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Community-acquired pneumonia (CAP) refers to infectious parenchymal lung inflammation acquired outside hospital settings. In China, its incidence is 7.13 per 1000 person-years, with over 10 million new cases annually. Elderly CAP patients carry a higher mortality risk. The predominant pathogens of CAP in China are Mycoplasma pneumoniae and Streptococcus pneumoniae, followed by Haemophilus influenzae, Staphylococcus aureus and other pathogens. Commonly used antibacterial agents include macrolides, penicillins, cephalosporins, respiratory quinolones and tetracyclines. Nevertheless, drug resistance is prevalent nationwide. Specifically, the resistance rate of Mycoplasma pneumoniae to macrolides ranges from 54.9% to 71.7%, while that of Streptococcus pneumoniae reaches as high as 77.2% to 93.8%. Therefore, novel antibacterial agents covering common pathogens with low cross-resistance are ur

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📋 Eligibility rules (as published)
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
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What it tests

  • This is a multicenter, single-arm, non-interventional study. No interventional measures will be adopted.
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Where

1 site
China-Japan Friendship Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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