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New trial aims to crack code of Drug-Resistant lung bug

NCT ID NCT04310930

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This clinical trial is testing different combinations of antibiotics to find the best way to treat a lung infection caused by Mycobacterium abscessus, a bacteria that is hard to kill. About 300 adults and children with this infection will receive various drug regimens, including amikacin and tigecycline. The goal is to see which approach clears the infection with the fewest side effects.

What this could mean

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

Active substance
Amikacin and tigecycline (antibiotics)
What this could lead to
If successful, this trial could identify the most effective and least toxic antibiotic regimen for a hard-to-treat lung infection, improving clearance rates and quality of life.
What could go wrong
This is a mid-stage trial with 300 participants, so results may not apply to everyone. The antibiotics can cause serious side effects, and the infection may still recur.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 300 people

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

Started

Mar 2020

Expected to finish

Jun 2030

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

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.

Eligibility criteria for the FORMaT trial can be applied at two levels: 1. Eligibility into the Intervention Program, or; 2. Eligibility into the Observational Cohort. Potential participants can only be enrolled in either the Intervention Program or the Observational Cohort at any one time. Provided the eligibility criteria are met, potential participants may either: 1. Enrol directly into the Intervention Program, or; 2. Enrol into the Observational Cohort and transition into the Intervention Program once they satisfy the inclusion criteria for this program which can occur at any time during the trial. Eligibility into the FORMaT trial will be assessed at screening. Observational Cohort participants who go on to meet the Intervention Program eligibility criteria can transition from the Observational Cohort to the Intervention Program. INTERVENTION PROGRAM ELIGIBILITY (APPENDIX A) Potential participants are eligible for the Intervention Program (Appendix A) if the criteria below are met. Eligible participants with mixed NTM infections (slow growers + MABS) or with recurrence of MABS infection following completion of previous treatment will be eligible if they meet the inclusion and exclusion criteria listed below. For eligible participants with mixed NTM infections additional therapy combinations are available as detailed in the relevant appendices. INTERVENTION PROGRAM INCLUSION CRITERIA 1. Positive MABS-PD diagnosis meeting all three American Thoracic Society clinical, radiological and microbiological diagnostic criteria for MABS-PD. Defined as: 1. Clinical: Pulmonary symptoms and exclusion of other diagnoses. 2. Radiological: Nodular or cavitary opacities on chest radiograph or a chest high-resolution computed tomography (HRCT) scan showing multifocal bronchiectasis with multiple small nodules. 3. Microbiological: MABS positive culture results from at least two separate expectorated sputum samples. or Positive culture results from at least one bronchial wash or lavage. or Transbronchial or other lung biopsy with mycobacterial histopathologic features (granulomatous inflammation or acid-fast bacilli (AFB)) and positive culture for NTM or biopsy showing mycobacterial histopathologic features (granulomatous inflammation or AFB) and one or more sputum or bronchial washes that are culture positive for NTM. Screening samples must be collected within the timeframes stated in the relevant appendix. 2. Male or female participants of any age. 3. Participant has not received treatment for MABS-PD in the 12 months preceding assessment of eligibility or as specified in the relevant appendix (this includes drugs prescribed for the treatment of other mycobacteria and/or other indications that may have activity against MABS, as specified in the FORMaT Prohibited Drug List Standard Operating Procedure (SOP)). 4. Informed consent signed by participant or parent/legal guardian if participant is under 18 years of age. 5. Ability to comply with study visits, therapies and study procedures as judged by the site investigator. INTERVENTION PROGRAM EXCLUSION CRITERIA * Participants receiving current treatment for MABS (this includes drugs prescribed for the treatment of other mycobacteria and/or other indications that may have activity against MABS, as specified in the FORMaT Prohibited Drug List SOP), except for participants taking azithromycin as part of routine treatment for CF or chronic infection-related pulmonary disease, or as specified in the relevant appendix. * Participants who have a QTc interval of \>500 milliseconds (QT interval corrected based on Fridericia method). * Participants who are pregnant or planning to continue breast feeding. * Known hypersensitivity or contraindication to any of the therapies for which no alternative option(s) have been provided. OBSERVATIONAL COHORT INCLUSION CRITERIA To be eligible to participate in the Observational Cohort the following criteria must be met: 1. Male and female participants of any age with at least one positive respiratory culture for MABS. 2. Informed consent signed by participant or parent/legal guardian if participant is under 18 years of age. 3. Ability to comply with study visits and study procedures as judged by the site investigator. OBSERVATIONAL COHORT EXCLUSION CRITERIA Potential participants will be ineligible to participate in the Observational Cohort if any of the following criterion are met: • Receiving active treatment for MABS within the previous 12 months (this includes drugs prescribed for the treatment of other mycobacteria and/or other indications that may have activity against MABS, as specified in the FORMaT Prohibited Drug List SOP, except for participants taking azithromycin as part of routine treatment for CF or chronic infection-related pulmonary disease). ADDITIONAL ELIGIBILITY CRITERIA Mixed NTM infections Participants who have cultured slow growing NTM of the same species two or more times in the 24 months prior to screening, with one of those cultures within the 6 months prior to screening, will be considered to have mixed NTM infection at the time of screening. The participants must meet all other inclusion criteria and no exclusion criteria to be eligible for participation. Ethambutol may be used in addition to trial therapies to cover mixed NTM infections considered to require treatment by their clinician. Appendix specific sub-studies and integrated studies Appendix specific sub-studies and integrated studies may have additional eligibility criteria which are described in each of the relevant appendices.

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Conditions

The condition(s) this trial relates to.

disease lung disorder 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.

Pulmonary disease due to mycobacteria (diagnosis)

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 places running it

    50 sites in 7 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Alder Hey Children NHS Foundation Trust

    NOT_YET_RECRUITING

    Liverpool, United Kingdom

  • Austin Hospital

    RECRUITING

    Heidelberg, Victoria, Australia

  • Belfast City Hospital

    NOT_YET_RECRUITING

    Belfast, United Kingdom

  • Birmingham Children's Hospital

    NOT_YET_RECRUITING

    Birmingham, United Kingdom

  • Birmingham Heartlands Hospital

    NOT_YET_RECRUITING

    Birmingham, United Kingdom

  • Bristol Royal Hospital for Children

    NOT_YET_RECRUITING

    Bristol, United Kingdom

  • Carmel Medical Centre

    NOT_YET_RECRUITING

    Haifa, Israel

  • Erasmus MC Sophia Children's Hospital

    NOT_YET_RECRUITING

    Rotterdam, Netherlands

  • Gold Coast University Hospital

    RECRUITING

    Gold Coast, Australia

  • Greenslopes Private Hospital,

    RECRUITING

    Greenslopes, Australia

  • Hadassah Ein Kerem Hospital

    NOT_YET_RECRUITING

    Jerusalem, Israel

  • John Hunter Children's Hospital

    NOT_YET_RECRUITING

    New Lambton Heights, Australia

  • John Hunter Hospital

    NOT_YET_RECRUITING

    New Lambton, Australia

  • Kaohsiung Medical University Hospital

    NOT_YET_RECRUITING

    Kaohsiung City, Taiwan

  • Macquarie University Hospital

    NOT_YET_RECRUITING

    Sydney, Australia

  • Mater Adult Hospital

    RECRUITING

    South Brisbane, Australia

  • National Taiwan University Hospital

    NOT_YET_RECRUITING

    Taipei, Taiwan

  • Noah's Ark Childrens Hospital for Wales

    NOT_YET_RECRUITING

    Cardiff, United Kingdom

  • Nottingham Children's Hosptial

    NOT_YET_RECRUITING

    Nottingham, United Kingdom

  • Perth Children's Hospital

    RECRUITING

    Perth, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, Australia

  • Queen Elizabeth University Hospital, Glasgow

    NOT_YET_RECRUITING

    Glasgow, United Kingdom

  • Queens Medical Centre

    NOT_YET_RECRUITING

    Nottingham, United Kingdom

  • Queensland Children's Hospital

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

    Contact Email: •••••@•••••

  • Rambam Health Care Campus

    NOT_YET_RECRUITING

    Haifa, Israel

  • Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, Australia

  • Royal Brompton Hosptial

    NOT_YET_RECRUITING

    London, United Kingdom

  • Royal Hospital for Children and Young People, Edinburgh

    NOT_YET_RECRUITING

    Edinburgh, United Kingdom

  • Royal Manchester Children's Hospital

    NOT_YET_RECRUITING

    Manchester, United Kingdom

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, Australia

  • Royal Perth Hospital

    RECRUITING

    Perth, Western Australia, 6000, Australia

  • Royal Prince Alfred Hospital

    NOT_YET_RECRUITING

    Camperdown, Australia

  • Schneider

    NOT_YET_RECRUITING

    Petah Tikva, Israel

  • Sheba Medical Centre

    NOT_YET_RECRUITING

    Ramat Gan Tel Aviv, Israel

  • Sir Charles Gairdiner Hospital

    RECRUITING

    Nedlands, Australia

  • Soroka Medical Centre

    NOT_YET_RECRUITING

    Beer-Sheeva, Israel

  • Southampton General Hospital

    NOT_YET_RECRUITING

    Southampton, United Kingdom

  • St George Hospital

    RECRUITING

    Kogarah, New South Wales, Australia

  • Sunshine Coast University Hospital

    RECRUITING

    Birtinya, Australia

  • Sydney Children's Hospital

    NOT_YET_RECRUITING

    Randwick, Australia

  • Tan Tock Seng Hospital Pte Ltd

    NOT_YET_RECRUITING

    Singapore, 308433, Singapore

  • The Alfred

    RECRUITING

    Prahran, Australia

  • The Children's Hospital at Westmead

    NOT_YET_RECRUITING

    Westmead, Australia

  • The Prince Charles Hospital

    RECRUITING

    Chermside, Australia

  • University Hospital Llandough

    NOT_YET_RECRUITING

    Penarth, United Kingdom

  • Welcome Wolfson Adult CF Centre (City Hospital Campus)

    NOT_YET_RECRUITING

    Nottingham, United Kingdom

  • Western General Hospital

    NOT_YET_RECRUITING

    Edinburgh, United Kingdom

  • Westmead Hospital

    NOT_YET_RECRUITING

    Westmead, Australia

  • Wythenshawe Hospital

    NOT_YET_RECRUITING

    Wythenshawe, United Kingdom