Lefamulin Post-Market Surveillance Study
A Multicenter, Single-arm, Real-world Study to Evaluate the Safety and Efficacy of Lefamulin in Patients With Community-acquired Pneumonia
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 urgently needed.
Lefamulin is the first systemic pleuromutilin antibacterial agent for human use. It binds to the peptidyl transferase center of bacterial 50S ribosomal subunit via dual A/P sites to inhibit bacterial protein synthesis. It features low cross-resistance and low potential to induce drug resistance, and exerts broad-spectrum antibacterial activity against common typical and atypical pathogens (including multi-drug resistant strains) causing CAP.
Multiple Phase III randomized controlled trials have verified that lefamulin achieves favorable early clinical response (ECR) and investigator-assessed clinical response (IACR) in CAP patients, providing solid evidence-based support for its clinical application. As a safer and more effective therapeutic option for CAP, lefamulin has been recommended by domestic and international clinical guidelines and expert consensus.
This study aims to evaluate the safety and efficacy of lefamulin in real-world clinical treatment among Chinese patients with CAP.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100029
- Reclutamiento
- China-Japan Friendship Hospital
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Contacto:
- Bin Cao
- Número de teléfono: 861084205566
- Correo electrónico: caobin_ben@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Signed informed consent form
- Clinical diagnosis of community-acquired pneumonia (CAP) by treating physicians
- Currently receiving lefamulin treatment or prescribed and agreed to initiate lefamulin therapy as determined by the treating physician
Exclusion Criteria:
- Patients with contraindications to lefamulin according to the approved prescribing information (e.g., known hypersensitivity to lefamulin or pleuromutilin class antibiotics)
- 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)
- Confirmed or suspected empyema via chest X-ray or CT examination
- Participation in any other ongoing interventional clinical trial
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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To evaluate the safety of lefamulin in the real-world treatment of patients with CAP
Periodo de tiempo: Visit 1 (Day 1: baseline, date of initial lefamulin administration) through Visit 4 (Days 27-33 post-administration)
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Treatment-emergent adverse events (TEAEs) will be collected from medical records, patient interviews, and laboratory findings. Events will be coded using MedDRA (or CTCAE v5.0 where applicable), and assessed for severity, seriousness, and causality to lefamulin by the investigator. Data will be summarized as: Number and percentage of participants with any TEAE, drug-related TEAE, serious adverse events (SAEs), and TEAEs leading to treatment discontinuation. Incidence by severity (mild, moderate, severe), system organ class, and preferred term. |
Visit 1 (Day 1: baseline, date of initial lefamulin administration) through Visit 4 (Days 27-33 post-administration)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of participants achieving Early Clinical Response (ECR).
Periodo de tiempo: Visit 2 (Days 4-6 after lefamulin administration)
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Early Clinical Response (ECR) is assessed at Visit 2 as the proportion of participants with improvement in at least two of the four cardinal symptoms of CAP (cough, sputum production, dyspnea, chest pain) without worsening of any symptom. Data will be summarized as number and percentage of participants achieving ECR in the intention-to-treat (ITT) population, with 95% confidence intervals. |
Visit 2 (Days 4-6 after lefamulin administration)
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Proportion of participants achieving Investigator-Assessed Clinical Response (IACR) at Test-of-Cure (TOC)
Periodo de tiempo: Visit 3 (within 2 days after end of treatment) and Visit 4 (5-10 days post-TOC, retrospective assessment)
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Investigator-Assessed Clinical Response (IACR) is defined as complete or partial resolution of signs and symptoms of community-acquired pneumonia. Assessments will be performed at end of treatment (Visit 3) and 5-10 days after TOC (Visit 4, retrospective). Data will be summarized as the number and percentage of participants achieving IACR at each time point in the clinically evaluable and modified ITT populations, with 95% confidence intervals. |
Visit 3 (within 2 days after end of treatment) and Visit 4 (5-10 days post-TOC, retrospective assessment)
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Health outcomes including hospital readmission/re-visit rate and change in EQ-5D-5L score
Periodo de tiempo: Up to Visit 4 (Days 27-33 after lefamulin administration)
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This measure includes: Rate of all-cause hospital readmission or pneumonia-related re-visit within 30 days. Change in health-related quality of life as measured by the EQ-5D-5L questionnaire from baseline (Visit 1) to Visit 4. EQ-5D-5L will be scored using the standard index value (0-1 scale, where 1 = full health). Data will be summarized as: Number and percentage of participants with hospital readmission/re-visit. Mean change in EQ-5D-5L index score from baseline, with standard deviation. |
Up to Visit 4 (Days 27-33 after lefamulin administration)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MPCN-LEF-2025-001
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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