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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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To evaluate the safety of lefamulin in the real-world treatment of patients with CAP
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of participants achieving Early Clinical Response (ECR).
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MPCN-LEF-2025-001
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