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New antibiotic lefamulin takes on Drug-Resistant pneumonia

NCT ID NCT07697885

Disease control Sponsor: Marubeni Pharmaceuticals (Suzhou) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study looks at how safe and effective the antibiotic lefamulin is for treating community-acquired pneumonia (CAP) in Chinese patients. CAP is a lung infection caught outside of hospitals, and many common antibiotics are becoming less effective due to drug resistance. Lefamulin works differently from other antibiotics and may be effective against resistant bacteria. Researchers will track side effects and how well patients recover in real-world medical settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lefamulin
What this could lead to
If successful, lefamulin could offer a new, effective antibiotic option for pneumonia, especially against drug-resistant bacteria.
What could go wrong
This is a real-world observational study, not a controlled trial, so results may be less definitive. Antibiotic resistance could still develop over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Community-Acquired Pneumonia pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Community-acquired pneumonia (CAP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

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