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Lefamulin Post-Market Surveillance Study

5 augusti 2026 uppdaterad av: Marubeni Pharmaceuticals (Suzhou) Co., Ltd.

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

1000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100029
        • Rekrytering
        • China-Japan Friendship Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

Inclusion Criteria:

  1. Signed informed consent form
  2. Clinical diagnosis of community-acquired pneumonia (CAP) by treating physicians
  3. Currently receiving lefamulin treatment or prescribed and agreed to initiate lefamulin therapy as determined by the treating physician

Exclusion Criteria:

  1. Patients with contraindications to lefamulin according to the approved prescribing information (e.g., known hypersensitivity to lefamulin or pleuromutilin class antibiotics)
  2. 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)
  3. Confirmed or suspected empyema via chest X-ray or CT examination
  4. Participation in any other ongoing interventional clinical trial

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To evaluate the safety of lefamulin in the real-world treatment of patients with CAP
Tidsram: 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.
Visit 1 (Day 1: baseline, date of initial lefamulin administration) through Visit 4 (Days 27-33 post-administration)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of participants achieving Early Clinical Response (ECR).
Tidsram: Visit 2 (Days 4-6 after lefamulin administration)

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)
Proportion of participants achieving Investigator-Assessed Clinical Response (IACR) at Test-of-Cure (TOC)
Tidsram: Visit 3 (within 2 days after end of treatment) and Visit 4 (5-10 days post-TOC, retrospective assessment)

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)
Health outcomes including hospital readmission/re-visit rate and change in EQ-5D-5L score
Tidsram: Up to Visit 4 (Days 27-33 after lefamulin administration)

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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Marubeni Pharmaceuticals (Suzhou) Co., Ltd.

Samarbetspartners

China-Japan Friendship Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 juni 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2028

Studieregistreringsdatum

Först inskickad

17 juni 2026

Först inskickad som uppfyllde QC-kriterierna

6 juli 2026

Första postat (Faktisk)

13 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 augusti 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MPCN-LEF-2025-001

Plan för individuella deltagardata (IPD)

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OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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