Actively Recruiting
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
Eligibility Criteria
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
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
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
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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