A Multicenter, Single-arm, Real-world Study to Evaluate the Safety and Efficacy of Lefamulin in Patients With Community-acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- To evaluate the safety of lefamulin in the real-world treatment of patients with CAP
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
To evaluate the safety of lefamulin in the real-world treatment of patients with CAP
时间窗: Visit 1 (Day 1: baseline, date of initial lefamulin administration) through Visit 4 (Days 27-33 post-administration)
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.
次要结局
- Proportion of participants achieving Early Clinical Response (ECR).(Visit 2 (Days 4-6 after lefamulin administration))
- Proportion of participants achieving Investigator-Assessed Clinical Response (IACR) at Test-of-Cure (TOC)(Visit 3 (within 2 days after end of treatment) and Visit 4 (5-10 days post-TOC, retrospective assessment))
- Health outcomes including hospital readmission/re-visit rate and change in EQ-5D-5L score(Up to Visit 4 (Days 27-33 after lefamulin administration))