Lefamulin Post-Market Surveillance Study
ConditionCommunity-Acquired Pneumonia (CAP)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMarubeni Pharmaceuticals (Suzhou) Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
A total of 1000 patients with CAP are planned to be enrolled in this study. All enrolled patients have been prescribed and scheduled to start lefamulin treatment or are already receiving lefamulin therapy. The decision to initiate lefamulin treatment is independent of this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
This is a multicenter, single-arm, non-interventional study. No interventional measures will be adopted.
Other interventionThis is a multicenter, single-arm, non-interventional study. No interventional measures will be adopted.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
To evaluate the safety of lefamulin in the real-world treatment of patients with CAP
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.
Time frame
Visit 1 (Day 1: baseline, date of initial lefamulin administration) through Visit 4 (Days 27-33 post-administration)Secondary outcomes
1
Proportion of participants achieving Early Clinical Response (ECR).
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.
Time frame
Visit 2 (Days 4-6 after lefamulin administration)2
Proportion of participants achieving Investigator-Assessed Clinical Response (IACR) at Test-of-Cure (TOC)
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.
Time frame
Visit 3 (within 2 days after end of treatment) and Visit 4 (5-10 days post-TOC, retrospective assessment)3
Health outcomes including hospital readmission/re-visit rate and change in EQ-5D-5L score
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.
Time frame
Up to Visit 4 (Days 27-33 after lefamulin administration)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
Lead sponsor
China-Japan Friendship Hospital
Collaborator
Source ClinicalTrials.gov