Actively Recruiting

Phase 2
Phase 3
All Genders
NCT04310930

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Led by The University of Queensland · Updated on 2026-05-11

300

Participants Needed

50

Research Sites

538 weeks

Total Duration

On this page

Sponsors

T

The University of Queensland

Lead Sponsor

A

Australian Government Department of Health and Ageing

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Positive diagnosis of Mycobacterium abscessus pulmonary disease meeting clinical, radiological, and microbiological criteria
  • Male or female participants of any age
  • No treatment for MABS-PD in the 12 months before eligibility assessment
  • Signed informed consent by participant or guardian if under 18 years old
  • Ability to follow study visits, treatments, and procedures as judged by site investigator
  • For observational cohort: at least one positive respiratory culture for MABS
  • Participants with mixed NTM infections or recurrence after previous treatment can be eligible if criteria met
Not Eligible

You will not qualify if you...

  • Currently receiving treatment for MABS, except azithromycin as routine treatment for cystic fibrosis or chronic pulmonary infection
  • QTc interval greater than 500 milliseconds
  • Pregnant or planning to continue breastfeeding
  • Known allergy or contraindication to study therapies without alternative options
  • For observational cohort: active treatment for MABS within previous 12 months except routine azithromycin use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 50 locations

1

St George Hospital

Kogarah, New South Wales, Australia

Actively Recruiting

2

Queensland Children's Hospital

South Brisbane, Queensland, Australia, 4101

Actively Recruiting

3

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Actively Recruiting

4

Austin Hospital

Heidelberg, Victoria, Australia

Actively Recruiting

5

Royal Melbourne Hospital

Parkville, Victoria, Australia

Actively Recruiting

6

Royal Perth Hospital

Perth, Western Australia, Australia, 6000

Actively Recruiting

7

Royal Adelaide Hospital

Adelaide, Australia

Actively Recruiting

8

Sunshine Coast University Hospital

Birtinya, Australia

Actively Recruiting

9

Royal Prince Alfred Hospital

Camperdown, Australia

Not Yet Recruiting

10

The Prince Charles Hospital

Chermside, Australia

Actively Recruiting

11

Gold Coast University Hospital

Gold Coast, Australia

Actively Recruiting

12

Greenslopes Private Hospital,

Greenslopes, Australia

Actively Recruiting

13

Sir Charles Gairdiner Hospital

Nedlands, Australia

Actively Recruiting

14

John Hunter Hospital

New Lambton, Australia

Not Yet Recruiting

15

John Hunter Children's Hospital

New Lambton Heights, Australia

Not Yet Recruiting

16

Perth Children's Hospital

Perth, Australia

Actively Recruiting

17

The Alfred

Prahran, Australia

Actively Recruiting

18

Sydney Children's Hospital

Randwick, Australia

Not Yet Recruiting

19

Mater Adult Hospital

South Brisbane, Australia

Actively Recruiting

20

Macquarie University Hospital

Sydney, Australia

Not Yet Recruiting

21

The Children's Hospital at Westmead

Westmead, Australia

Not Yet Recruiting

22

Westmead Hospital

Westmead, Australia

Not Yet Recruiting

23

Rigshospitalet

Copenhagen, Denmark

Actively Recruiting

24

Soroka Medical Centre

Beer-Sheeva, Israel

Not Yet Recruiting

25

Carmel Medical Centre

Haifa, Israel

Not Yet Recruiting

26

Rambam Health Care Campus

Haifa, Israel

Not Yet Recruiting

27

Hadassah Ein Kerem Hospital

Jerusalem, Israel

Not Yet Recruiting

28

Schneider

Petah Tikva, Israel

Not Yet Recruiting

29

Sheba Medical Centre

Ramat Gan Tel Aviv, Israel

Not Yet Recruiting

30

Erasmus MC Sophia Children's Hospital

Rotterdam, Netherlands

Not Yet Recruiting

31

Tan Tock Seng Hospital Pte Ltd

Singapore, Singapore, 308433

Not Yet Recruiting

32

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Not Yet Recruiting

33

National Taiwan University Hospital

Taipei, Taiwan

Not Yet Recruiting

34

Belfast City Hospital

Belfast, United Kingdom

Not Yet Recruiting

35

Birmingham Children's Hospital

Birmingham, United Kingdom

Not Yet Recruiting

36

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Not Yet Recruiting

37

Bristol Royal Hospital for Children

Bristol, United Kingdom

Not Yet Recruiting

38

Noah's Ark Childrens Hospital for Wales

Cardiff, United Kingdom

Not Yet Recruiting

39

Royal Hospital for Children and Young People, Edinburgh

Edinburgh, United Kingdom

Not Yet Recruiting

40

Western General Hospital

Edinburgh, United Kingdom

Not Yet Recruiting

41

Queen Elizabeth University Hospital, Glasgow

Glasgow, United Kingdom

Not Yet Recruiting

42

Alder Hey Children NHS Foundation Trust

Liverpool, United Kingdom

Not Yet Recruiting

43

Royal Brompton Hosptial

London, United Kingdom

Not Yet Recruiting

44

Royal Manchester Children's Hospital

Manchester, United Kingdom

Not Yet Recruiting

45

Nottingham Children's Hosptial

Nottingham, United Kingdom

Not Yet Recruiting

46

Queens Medical Centre

Nottingham, United Kingdom

Not Yet Recruiting

47

Welcome Wolfson Adult CF Centre (City Hospital Campus)

Nottingham, United Kingdom

Not Yet Recruiting

48

University Hospital Llandough

Penarth, United Kingdom

Not Yet Recruiting

49

Southampton General Hospital

Southampton, United Kingdom

Not Yet Recruiting

50

Wythenshawe Hospital

Wythenshawe, United Kingdom

Not Yet Recruiting

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Research Team

C

Claire Wainwright, MD

CONTACT

K

Kara Brady, MPharm

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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