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New drug combo takes on rare, Drug-Resistant lung bug

NCT ID NCT07485010

Disease control Sponsor: The University of Queensland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a new combination of antibiotics (called Arm D) against standard treatments for a rare lung infection caused by Mycobacterium abscessus. About 300 people with or without cystic fibrosis will take part. The goal is to see if the new combo clears the infection better and with fewer side effects over a shorter treatment period.

What this could mean

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

Active substance
sulbactam-durlobactam plus ceftriaxone, amoxicillin, azithromycin, and clofazimine
What this could lead to
If it works, this could point toward a more effective treatment for a hard-to-treat lung infection, potentially reducing treatment duration and side effects.
What could go wrong
This is an early phase 2 trial with only 300 participants, so results may not apply to everyone. The new combination may not clear the infection better than current treatments and could cause unexpected side effects.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

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

Expected to start

Apr 2027

An estimate. Start dates often move.

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

12 years and older

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. Must meet eligibility criteria as per the FORMaT Master Protocol and Appendix A1 Inclusion Criteria (NCT04310930). 2. Male or female participants aged 12 years and older. Exclusion Criteria: 1. Must not have any exclusion criteria as per the FORMaT Master Protocol and Appendix A1 Exclusion Criteria (NCT04310930). 2. Participants aged \<12 years old. 3. Participants aged between 12 and \<18years old with clinically significant renal impairment as indicated by an age-appropriate estimated creatinine clearance. 4. Known hypersensitivity to any of the therapies for which no alternative option(s) have been provided. This includes: * Sulbactam/durlobactam * Ceftriaxone, * Amoxicillin, * Macrolide antibiotics, and * Clofazimine.

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Conditions

The condition(s) this trial relates to.

Infections mycobacterial infectious disease Mycobacterium Infections, Nontuberculous pulmonary non-tuberculous mycobacterial infection

As listed by the trial registrant

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

Mycobacterium abscessus infection Mycobacterium abscessus pulmonary disease Non-tuberculous mycobacteria pulmonary disease Non-tuberculous mycobacterial (NTM) infections

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  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

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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