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Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-02

Study Completion Date

2030-06-30

Brief Summary

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Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease (MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated lung function decline, impaired quality of life, more challenging lung transplantation, and increased mortality. While the overall numbers affected is small, the prevalence of infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as well as developing biomarkers (serology, gene expression signatures, and radiology) to guide decisions for starting treatment and measuring disease severity in patients with MABS PD.

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Detailed Description

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Mycobacterium abscessus (MABS) are a group of non-tuberculous mycobacteria (NTM) found in water and soil habitats that exhibit high levels of intrinsic multi-drug resistance. They are recognised opportunistic human pathogens capable of causing chronic pulmonary disease (MABS-PD), predominantly in individuals with underlying inflammatory lung diseases.

Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) is an iterative, standing, platform trial with innovative and adaptive properties that evaluate and develop the optimal combinations of therapies for children and adults with MABS-PD to clear MABS infection with acceptable tolerance. We will use these opportunities afforded by the clinical trial platform to establish discovery studies to: (i) understand the effects of disease and treatment on health-related quality of life, (ii) determine cost effectiveness of interventions, (iii) optimise pharmacokinetic drug dosing, (iv) understand susceptibility to MABs-PD, (v) develop biomarkers of clinical disease, (vi) investigate genomics of MABs strains causing MABs-PD and development of antimicrobial resistance.

FORMaT provides a pragmatic design to address challenges to develop an evidence base for the first time for MABS-PD. Initially, the trial has been designed to test therapies that are currently the basis for treatment guidelines for MABS-PD. The trial has the capacity to add new treatments and to eliminate therapies because of futility as they either lack efficacy or cause unacceptable toxicity. Novel therapeutic approaches are then tested against the previously determined optimal approaches, thus leading in an iterative fashion to improve microbiological clearance, and health outcomes associated with MABS-PD. The trial is designed as a series of trials within the main trial to enable investigation of the different phases of treatment; intensive (intravenous treatment phase) and consolidation (oral and or inhaled treatment phase) based on clinical guidelines. The primary outcome for each trial is microbiological clearance with clinical tolerance (Grade 1 or 2) based on Common Terminology Criteria for Adverse Events (version 5). This enables subjects to continue in the trial even if tolerance is poor or they change treatments in a specific phase of the trial as those events contribute to the primary outcome determination.

Conditions

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Pulmonary Disease Due to Mycobacteria (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are 2 different phases of treatment; intensive therapy (IT) followed by consolidation therapy (CT). Intervention cohort participants will be randomised to 1 of 3 treatment arms for 6 weeks of IT. After the first 6 weeks of IT participants who are culture positive for MABS are randomised to either prolonged IT (additional 6 weeks of IT) then CT, or to commence CT. If, at week 6 participants are MABS culture-negative they will commence CT. Participants commencing CT are randomised to one of two treatment arms for 50 weeks. There are 12 possible paths through the trial. This standing platform trial design enables assessment of short IT, prolonged IT, and CT components individually as well as the overall combination of IT and CT. After 100 patients have completed short IT an interim analysis will be conducted, and Bayesian adaptive randomisation (BAR) will be implemented. New interventions may be added or stopped in the future due to lack of benefit at interim analyses.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The FORMAT trial may include placebo controlled double blind randomised interventions in the future, but the initial intervention program is randomised but open label.

There will be three stages of randomisation in the intervention program of this study, dictating the treatment the participant will receive. Randomisation at each level will be conducted using the method of minimisation. Each randomisation level will be planned to enable flexibility via pre-planned adaptations.

Study Groups

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Intensive Therapy A

Following Randomisation 1, Participants will receive intensive drug therapy in the form of IV amikacin, IV tigecycline, IV cefoxitin/imipenem + oral azithromycin AND clofazimine.

Group Type ACTIVE_COMPARATOR

Amikacin

Intervention Type DRUG

Adults: Intravenous amikacin 5mg/kg once daily or 7.5mg/kg twice daily or 20-25 mg/kg thrice weekly. Children:Intravenous amikacin 15-30 mg/kg once daily, maximum dose 1500mg

Tigecycline

Intervention Type DRUG

Adults: Intravenous Tigecycline 25 mg increasing by 5 mg every two doses until either maximum dose reached (50mg) or until patient is unable to tolerate twice daily. Children (≥8 years of age) intravenous tigecycline: Day 1- 0.6mg/kg twice daily to a maximum of 25mg. Day 2- 0.6mg/kg (maximum 25mg) in the morning, 1.2 mg/kg (maximum 50mg) at night. Day 3- 1.2mg/kg (maximum 50 mg) twice daily

Imipenem

Intervention Type DRUG

Adults: Intravenous Imipenem (≥50kg) 500mg twice daily (\<50kg) 15 mg/kg twice daily. Children: intravenous imipenem Day 1- 2- 25mg/kg (maximum 1g) twice daily. DAY 3- 25mg/kg (maximum 1g) four times daily (drop to 3 if not tolerated).

Cefoxitin

Intervention Type DRUG

Adults: If imipenem is poorly tolerated intravenous cefoxitin 200 mg/kg thrice daily. Children: if imipenem is poorly tolerated intravenous cefoxitin 50mg/kg (maximum 4g) four times daily.

Azithromycin

Intervention Type DRUG

Adults: Oral azithromycin 500mg (≥40kg) once daily, (\<40kg) 250mg once daily.During consolidaiton: 500mg (≥40kg) thrice weekly, (\<40kg) 250mg thrice weekly.

Children: Oral azithromycin:10mg/kg (maximum 500mg) once daily. During consolidation 10mg/kg once daily maximum 500mg.

Clarithromycin

Intervention Type DRUG

Adult: If azithromycin is poorly tolerated use oral clarithromycin 500mg twice daily.Children: If azithromycin is poorly tolerated use oral clarithromycin. In children 1 month old- 11years of age the following dosing applies: \<8kg: 7.5mg/kg twice daily, maximum dose 62.5mg, 8-11kg: 62.5mg twice daily, maximum dose 62.5mg, 12-19 kg: 125mg twice daily, maximum dose 125mg, 20-29 kg: 187.5mg twice daily, maximum dose 187.5mg, 30-40 kg: 250mg twice daily, maximum dose 250mg, Children 12-18 years of age: 500 mg twice daily

Clofazimine

Intervention Type DRUG

Adult: Oral clofazimine 100mg once daily. Children: Oral clofazimine: 3-5mg/kg once daily. Maximum dose of 50mg once daily if \<40kg or 100mg if ≥40kg once daily.

Ethambutol

Intervention Type DRUG

Adults: with confirmed mixed NTM infections (slow growers + MABS) oral ethambutol can be added at either 15 mg/kg once daily or 25mg/kg thrice weekly. Children with confirmed mixed NTM infections (slow growers + MABS) oral ethambutol can be added at 20 mg/kg once daily.

Intensive Therapy B

Following Randomisation 1, Participants will receive inhaled amikacin (IA), IV tigecycline, IV cefoxitin/imipenem + oral azithromycin/oral clarithromycin AND clofazimine.

Group Type EXPERIMENTAL

Tigecycline

Intervention Type DRUG

Imipenem

Intervention Type DRUG

Cefoxitin

Intervention Type DRUG

Adults: If imipenem is poorly tolerated intravenous cefoxitin 200 mg/kg thrice daily. Children: if imipenem is poorly tolerated intravenous cefoxitin 50mg/kg (maximum 4g) four times daily.

Azithromycin

Intervention Type DRUG

Clarithromycin

Intervention Type DRUG

Clofazimine

Intervention Type DRUG

Adult: Oral clofazimine 100mg once daily. Children: Oral clofazimine: 3-5mg/kg once daily. Maximum dose of 50mg once daily if \<40kg or 100mg if ≥40kg once daily.

Ethambutol

Intervention Type DRUG

Amikacin

Intervention Type DRUG

adult: Inhaled amikacin 500mg twice daily. Children: Inhaled amikacin 500mg twice daily

Intensive Therapy C

Following Randomisation 1, Participants will receive intensive drug therapy in the form of IV amikacin, IV tigecycline, IV cefoxitin/imipenem + oral azithromycin/oral clarithromycin.

Group Type EXPERIMENTAL

Amikacin

Intervention Type DRUG

Adults: Intravenous amikacin 5mg/kg once daily or 7.5mg/kg twice daily or 20-25 mg/kg thrice weekly. Children:Intravenous amikacin 15-30 mg/kg once daily, maximum dose 1500mg

Tigecycline

Intervention Type DRUG

Imipenem

Intervention Type DRUG

Cefoxitin

Intervention Type DRUG

Adults: If imipenem is poorly tolerated intravenous cefoxitin 200 mg/kg thrice daily. Children: if imipenem is poorly tolerated intravenous cefoxitin 50mg/kg (maximum 4g) four times daily.

Azithromycin

Intervention Type DRUG

Clarithromycin

Intervention Type DRUG

Ethambutol

Intervention Type DRUG

Consolidation A

Oral clofazimine + oral azithromycin/oral clarithromycin in combination with one to three of the following oral antibiotics: oral linezolid, oral co-trimoxazole, oral doxycycline, oral moxifloxacin, oral bedaquiline (adults only), oral rifabutin.

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

Clarithromycin

Intervention Type DRUG

Clofazimine

Intervention Type DRUG

Adult: Oral clofazimine 100mg once daily. Children: Oral clofazimine: 3-5mg/kg once daily. Maximum dose of 50mg once daily if \<40kg or 100mg if ≥40kg once daily.

Ethambutol

Intervention Type DRUG

Linezolid

Intervention Type DRUG

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral linezolid 600mg once daily.

Children: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Age 1 week - 9 years 10mg/kg twice daily maximum dose of 300mg. Age 10-12 years 10mg/kg twice daily maximum dose of 600mg. \>12 years 600mg once daily.

co-trimoxazole

Intervention Type DRUG

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral Co-trimoxazole (TMP-SMX) 160/800mg twice daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral co-trimoxazole 5mg TMP/kg maximum dose of 160mg TMP/ 800mg SMX twice daily.

Doxycycline

Intervention Type DRUG

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline 100mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline (ages ≥ 8 years) 2mg/kg once daily maximum dose 100mg.

Moxifloxacin

Intervention Type DRUG

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 400mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 10-15mg/kg once daily, maximum dose 400mg

Bedaquiline

Intervention Type DRUG

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral bedaquiline (18-64 years of age) 400mg once daily for the first two weeks followed by 400mg thrice weekly for 22 weeks (maximum duration of 6 months).

Rifabutin

Intervention Type DRUG

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin: 5mg/kg once daily, maximum 300-450mg. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin 5mg/kg once daily

Consolidation B

Inhaled amikacin (IA), oral clofazimine + oral azithromycin/oral clarithromycin in combination with one to three of the following oral antibiotics: oral linezolid, oral co-trimoxazole, oral doxycycline, oral moxifloxacin, oral bedaquiline (adults only), oral rifabutin.

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

Clarithromycin

Intervention Type DRUG

Clofazimine

Intervention Type DRUG

Adult: Oral clofazimine 100mg once daily. Children: Oral clofazimine: 3-5mg/kg once daily. Maximum dose of 50mg once daily if \<40kg or 100mg if ≥40kg once daily.

Ethambutol

Intervention Type DRUG

Amikacin

Intervention Type DRUG

adult: Inhaled amikacin 500mg twice daily. Children: Inhaled amikacin 500mg twice daily

Linezolid

Intervention Type DRUG

co-trimoxazole

Intervention Type DRUG

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral Co-trimoxazole (TMP-SMX) 160/800mg twice daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral co-trimoxazole 5mg TMP/kg maximum dose of 160mg TMP/ 800mg SMX twice daily.

Doxycycline

Intervention Type DRUG

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline 100mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline (ages ≥ 8 years) 2mg/kg once daily maximum dose 100mg.

Moxifloxacin

Intervention Type DRUG

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 400mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 10-15mg/kg once daily, maximum dose 400mg

Bedaquiline

Intervention Type DRUG

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral bedaquiline (18-64 years of age) 400mg once daily for the first two weeks followed by 400mg thrice weekly for 22 weeks (maximum duration of 6 months).

Rifabutin

Intervention Type DRUG

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin: 5mg/kg once daily, maximum 300-450mg. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin 5mg/kg once daily

Interventions

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Amikacin

Adults: Intravenous amikacin 5mg/kg once daily or 7.5mg/kg twice daily or 20-25 mg/kg thrice weekly. Children:Intravenous amikacin 15-30 mg/kg once daily, maximum dose 1500mg

Intervention Type DRUG

Tigecycline

Intervention Type DRUG

Imipenem

Intervention Type DRUG

Cefoxitin

Adults: If imipenem is poorly tolerated intravenous cefoxitin 200 mg/kg thrice daily. Children: if imipenem is poorly tolerated intravenous cefoxitin 50mg/kg (maximum 4g) four times daily.

Intervention Type DRUG

Azithromycin

Intervention Type DRUG

Clarithromycin

Intervention Type DRUG

Clofazimine

Adult: Oral clofazimine 100mg once daily. Children: Oral clofazimine: 3-5mg/kg once daily. Maximum dose of 50mg once daily if \<40kg or 100mg if ≥40kg once daily.

Intervention Type DRUG

Ethambutol

Intervention Type DRUG

Amikacin

adult: Inhaled amikacin 500mg twice daily. Children: Inhaled amikacin 500mg twice daily

Intervention Type DRUG

Linezolid

Intervention Type DRUG

co-trimoxazole

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral Co-trimoxazole (TMP-SMX) 160/800mg twice daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral co-trimoxazole 5mg TMP/kg maximum dose of 160mg TMP/ 800mg SMX twice daily.

Intervention Type DRUG

Doxycycline

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline 100mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline (ages ≥ 8 years) 2mg/kg once daily maximum dose 100mg.

Intervention Type DRUG

Moxifloxacin

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 400mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 10-15mg/kg once daily, maximum dose 400mg

Intervention Type DRUG

Bedaquiline

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral bedaquiline (18-64 years of age) 400mg once daily for the first two weeks followed by 400mg thrice weekly for 22 weeks (maximum duration of 6 months).

Intervention Type DRUG

Rifabutin

Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin: 5mg/kg once daily, maximum 300-450mg. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin 5mg/kg once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

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.

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.

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.

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.

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).

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Claire Wainright

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St George Hospital

Kogarah, New South Wales, Australia

Site Status RECRUITING

Queensland Children's Hospital

South Brisbane, Queensland, Australia

Site Status RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Austin Hospital

Heidelberg, Victoria, Australia

Site Status RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status RECRUITING

Royal Perth Hospital

Perth, Western Australia, Australia

Site Status RECRUITING

Royal Adelaide Hospital

Adelaide, , Australia

Site Status RECRUITING

Sunshine Coast University Hospital

Birtinya, , Australia

Site Status RECRUITING

Royal Prince Alfred Hospital

Camperdown, , Australia

Site Status NOT_YET_RECRUITING

The Prince Charles Hospital

Chermside, , Australia

Site Status RECRUITING

Gold Coast University Hospital

Gold Coast, , Australia

Site Status RECRUITING

Greenslopes Private Hospital,

Greenslopes, , Australia

Site Status RECRUITING

Sir Charles Gairdiner Hospital

Nedlands, , Australia

Site Status RECRUITING

John Hunter Hospital

New Lambton, , Australia

Site Status NOT_YET_RECRUITING

John Hunter Children's Hospital

New Lambton Heights, , Australia

Site Status NOT_YET_RECRUITING

Perth Children's Hospital

Perth, , Australia

Site Status RECRUITING

The Alfred

Prahran, , Australia

Site Status RECRUITING

Sydney Children's Hospital

Randwick, , Australia

Site Status NOT_YET_RECRUITING

Mater Adult Hospital

South Brisbane, , Australia

Site Status RECRUITING

Macquarie University Hospital

Sydney, , Australia

Site Status NOT_YET_RECRUITING

The Children's Hospital at Westmead

Westmead, , Australia

Site Status NOT_YET_RECRUITING

Westmead Hospital

Westmead, , Australia

Site Status NOT_YET_RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Soroka Medical Centre

Beer-Sheeva, , Israel

Site Status NOT_YET_RECRUITING

Carmel Medical Centre

Haifa, , Israel

Site Status NOT_YET_RECRUITING

Rambam Health Care Campus

Haifa, , Israel

Site Status NOT_YET_RECRUITING

Hadassah Ein Kerem Hospital

Jerusalem, , Israel

Site Status NOT_YET_RECRUITING

Schneider

Petah Tikva, , Israel

Site Status NOT_YET_RECRUITING

Sheba Medical Centre

Ramat Gan Tel Aviv, , Israel

Site Status NOT_YET_RECRUITING

Erasmus MC Sophia Children's Hospital

Rotterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Tan Tock Seng Hospital Pte Ltd

Singapore, , Singapore

Site Status NOT_YET_RECRUITING

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status NOT_YET_RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status NOT_YET_RECRUITING

Belfast City Hospital

Belfast, , United Kingdom

Site Status NOT_YET_RECRUITING

Birmingham Children's Hospital

Birmingham, , United Kingdom

Site Status NOT_YET_RECRUITING

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Site Status NOT_YET_RECRUITING

Bristol Royal Hospital for Children

Bristol, , United Kingdom

Site Status NOT_YET_RECRUITING

Noah's Ark Childrens Hospital for Wales

Cardiff, , United Kingdom

Site Status NOT_YET_RECRUITING

Royal Hospital for Children and Young People, Edinburgh

Edinburgh, , United Kingdom

Site Status NOT_YET_RECRUITING

Western General Hospital

Edinburgh, , United Kingdom

Site Status NOT_YET_RECRUITING

Queen Elizabeth University Hospital, Glasgow

Glasgow, , United Kingdom

Site Status NOT_YET_RECRUITING

Alder Hey Children NHS Foundation Trust

Liverpool, , United Kingdom

Site Status NOT_YET_RECRUITING

Royal Brompton Hosptial

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Royal Manchester Children's Hospital

Manchester, , United Kingdom

Site Status NOT_YET_RECRUITING

Nottingham Children's Hosptial

Nottingham, , United Kingdom

Site Status NOT_YET_RECRUITING

Queens Medical Centre

Nottingham, , United Kingdom

Site Status NOT_YET_RECRUITING

Welcome Wolfson Adult CF Centre (City Hospital Campus)

Nottingham, , United Kingdom

Site Status NOT_YET_RECRUITING

University Hospital Llandough

Penarth, , United Kingdom

Site Status NOT_YET_RECRUITING

Southampton General Hospital

Southampton, , United Kingdom

Site Status NOT_YET_RECRUITING

Wythenshawe Hospital

Wythenshawe, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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Australia Denmark Israel Netherlands Singapore Taiwan United Kingdom

Central Contacts

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Claire Wainwright, MD

Role: CONTACT

[email protected]

+61730697322

Kara Brady, MPharm

Role: CONTACT

[email protected]

+61730697618

Facility Contacts

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Tiffany Jong

Role: primary

[email protected]

+61730697620

References

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Jong T, Baird T, Barr HL, Bell S, Bigirumurame T, Brady K, Burke A, Byrnes J, Caudri D, Clark JE, Coin LJM, Goh F, Grimwood K, Hicks D, Jayawardana K, Joshi S, Lee K, Qvist T, Reid D, Rice M, Roberts JA, Rogers G, Shackleton C, Sly PD, Smyth AR, Stevens L, Stockwell R, Tarique A, Taylor S, Thomson R, Tiddens HAWM, Wang XF, Wason J, Wainwright C. Finding the optimal regimen for Mycobacteroides abscessus treatment (FORMaT) in people with Mycobacteroides abscessus pulmonary disease: a multicentre, randomised, multi-arm, adaptive platform trial. BMJ Open. 2025 Sep 21;15(9):e096188. doi: 10.1136/bmjopen-2024-096188.

Reference Type DERIVED

PMID: 40976660 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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U1111-1209-0672

Identifier Type: -

Identifier Source: org_study_id

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