Community-Acquired Pneumonia (CAP)NCT07697885
Lefamulin Post-Market Surveillance Study
An observational study of Community-Acquired Pneumonia (CAP), run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Community-Acquired Pneumonia (CAP)
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 31 Dec 2028
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Bin Cao, 861084205566, caobin_ben@163.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Community-Acquired Pneumonia (CAP)
- Being tested
- This is a multicenter, single-arm, non-interventional study. No interventional measures will be adopted.
- Keywords
- lefamulin, post-marketing, real-world study, community-acquired bacterial pneumonia, antibiotic, pleuromutilin
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a multicenter, single-arm, non-interventional study. No interventional measures will be adopted.Other
This is a multicenter, single-arm, non-interventional study. No interventional measures will be adopted.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1 (Day 1: baseline, date of initial lefamulin administration) through Visit 4 (Days 27-33 post-administration)
Secondary outcomes (3)
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.
Measured: Visit 2 (Days 4-6 after lefamulin administration)
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.
Measured: 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
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.
Measured: Up to Visit 4 (Days 27-33 after lefamulin administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start30 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Acquired Pneumonia (CAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697885
- Sponsor's protocol ID
- MPCN-LEF-2025-001
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Real-world Study to Evaluate the Safety and Efficacy of Lefamulin in Patients With Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT07697885
- Acronym / sponsor ID
- MPCN-LEF-2025-001
- Conditions
- Community-Acquired Pneumonia (CAP)
- Keywords
- lefamulin, post-marketing, real-world study, community-acquired bacterial pneumonia, antibiotic, pleuromutilin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a multicenter, single-arm, non-interventional study. No interventional measures will be adopted.This is a multicenter, single-arm, non-interventional study. No interventional measures will be adopted. | Other | – |
Primary outcome
To evaluate the safety of lefamulin in the real-world treatment of patients with CAP
Time frame: 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.
3 secondary outcomes
Proportion of participants achieving Early Clinical Response (ECR).
Time frame: Visit 2 (Days 4-6 after lefamulin administration)
Proportion of participants achieving Investigator-Assessed Clinical Response (IACR) at Test-of-Cure (TOC)
Time frame: 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
Time frame: Up to Visit 4 (Days 27-33 after lefamulin administration)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Community-Acquired Pneumonia (CAP)
RecruitingPhase 3
CLARITHROMYCIN TO PREVENT SECONDARY INFECTIONS IN PATIENTS WITH SEPSIS FOLLOWING LOWER RESPIRATORY TRACT INFECTIONS: THE CLASSIFY TRIAL
Sepsis
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
RecruitingObservational study
Chest Radiography Versus Ultra-Low-Dose Chest Computed Tomography in Adults in the Emergency Department
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
Recruiting
Noninvasive Support Methods for Acute Respiratory Failure of Community-acquired Pneumonia
Community-acquired Pneumonia, Community-Acquired Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-Acquired Pneumonia (CAP), run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of lefamulin in the real-world treatment of patients with CAP (time frame: Visit 1 (Day 1: baseline, date of initial lefamulin administration) through Visit 4 (Days 27-33 post-administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.