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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04310930




Registration number
NCT04310930
Ethics application status
Date submitted
28/02/2020
Date registered
17/03/2020

Titles & IDs
Public title
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
Scientific title
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT)
Secondary ID [1] 0 0
U1111-1209-0672
Universal Trial Number (UTN)
Trial acronym
FORMaT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease Due to Mycobacteria (Diagnosis) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Amikacin
Treatment: Drugs - Tigecycline
Treatment: Drugs - Imipenem
Treatment: Drugs - Cefoxitin
Treatment: Drugs - Azithromycin
Treatment: Drugs - Clarithromycin
Treatment: Drugs - Clofazimine
Treatment: Drugs - Ethambutol
Treatment: Drugs - Amikacin
Treatment: Drugs - Linezolid
Treatment: Drugs - co-trimoxazole
Treatment: Drugs - Doxycycline
Treatment: Drugs - Moxifloxacin
Treatment: Drugs - Bedaquiline
Treatment: Drugs - Rifabutin

Active comparator: 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.

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

Experimental: 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.

Active comparator: 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.

Experimental: 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.


Treatment: Drugs: 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

Treatment: Drugs: Tigecycline
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

Treatment: Drugs: Imipenem
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).

Treatment: Drugs: 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.

Treatment: Drugs: Azithromycin
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.

Treatment: Drugs: Clarithromycin
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

Treatment: Drugs: 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.

Treatment: Drugs: Ethambutol
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.

Treatment: Drugs: Amikacin
adult: Inhaled amikacin 500mg twice daily. Children: Inhaled amikacin 500mg twice daily

Treatment: Drugs: Linezolid
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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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

Treatment: Drugs: 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).

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Appendix A1 - MABS clearance from respiratory samples with tolerance at final outcome
Assessment method [1] 0 0
The probability of MABS clearance with good tolerance at final outcome. MABS clearance defined as: Negative MABS cultures from 4 consecutive sputum samples with one of those sputum specimens collected four weeks after the completion of consolidation therapy or a MABS negative BAL collected four weeks after completion of consolidation. Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
Timepoint [1] 0 0
56 weeks for participants who received short intensive therapy and 62 weeks for participants who received prolonged intensive therapy.
Primary outcome [2] 0 0
Nested Study A1.1 Short Intensive Therapy - MABS Clearance
Assessment method [2] 0 0
The number of patients in each group with microbiological clearance of MABS with good tolerance (in accordance with CTCAE). MABs clearance based on results from 3 sputum specimens or one BAL. Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
Timepoint [2] 0 0
Samples collected at 4 weeks and culture results determined at 6 weeks
Primary outcome [3] 0 0
Nested study A1.1.1 Efficacy of inhaled Amikacin during intensive therapy in comparison to intravenous Amikacin in the treatment of MABS-PD
Assessment method [3] 0 0
The number of patients in each group with microbiological clearance of MABS with good tolerability at completion of short intensive therapy with the use of inhaled amikacin (Arm B) and with the use of IV amikacin (Arm A) given during intensive phase. Clearance will be based on results from 3 consecutive sputum or 1 BAL sample.Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
Timepoint [3] 0 0
samples collected at 4 weeks and culture results determined at 6 weeks
Primary outcome [4] 0 0
Nested Study A1.1.2 Efficacy of additional clofazimine during short intensive therapy in comparison to no additional clofazimine for treatment of MABS-PD
Assessment method [4] 0 0
The number of patients in each group with microbiological clearance of MABS with good tolerability at completion of short intensive therapy with the use of additional clofazimine (Arm A) and without the use of additional clofazimine (Arm C) given during intensive phase. Clearance will be based on results from 3 consecutive sputum or 1 BAL sample.Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
Timepoint [4] 0 0
samples collected at 4 weeks and culture results determined at 6 weeks
Primary outcome [5] 0 0
Nested Study A1.2 - Comparison of microbiological clearance of MABS with good tolerability at 12 weeks in patients with MABS positive cultures at 6 weeks and allocated to prolonged intensive therapy and those allocated to consolidation therapy.
Assessment method [5] 0 0
The number of patients in each group with clearance of MABS at 12 weeks with good tolerance. Clearance will be based on the results of 3 consecutive sputum samples or 1 BAL sample.Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
Timepoint [5] 0 0
samples collected at 10 weeks and culture results determined at 12 weeks
Primary outcome [6] 0 0
Nested Study 1.3 Consolidation Therapy - Comparison of MABS clearance between those allocated to consolidation therapy with oral treatment and those allocated to consolidation with oral therapy and additional inhaled amikacin
Assessment method [6] 0 0
The number of patients with microbiological clearance of MABS with good tolerability between those allocated to consolidation therapy with oral treatment and those allocated to consolidation therapy with oral therapy and additional inhaled amikacin. MABS clearance based on 3 consecutive sputum samples or 1 BAL sample.Tolerance will be defined using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either possibly, probably or definitely related to study drug will be assessed in the determination of tolerance. "Good" tolerance defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" as any adverse events coded as CTCAE grades 3, 4, or 5.
Timepoint [6] 0 0
52 weeks or 58 weeks depending on clearance of MABS at 4 weeks, with those allocated to short IT completing at 52 weeks and those allocated to prolonged IT completing at 58 weeks.
Secondary outcome [1] 0 0
The probability of microbiological clearance of MABS at time point final, irrespective of toxicity for participants according to treatment path.
Assessment method [1] 0 0
Probability of microbiological clearance irrespective of adverse event reporting.
Timepoint [1] 0 0
6 weeks, 12 weeks, at end of consolidation (52 and 58 weeks) and at final outcomes at 56 weeks and 62 weeks
Secondary outcome [2] 0 0
The safety of the treatment combinations in patients with MABS
Assessment method [2] 0 0
The number of participants with treatment-related adverse events as assessed by CTCAE version 5 at completion of short IT, at completion of prolonged IT, at completion of CT and at final outcomes.
Timepoint [2] 0 0
6 weeks and 12 weeks and at end of consolidation (52 and 58 weeks) and after trial has been completed
Secondary outcome [3] 0 0
The relative change in FEV1 z-score between treatment groups for time point final compared with time point start in patients who do and who do not clear MABS at time point final.
Assessment method [3] 0 0
Relative change in FEV1 z score compared between treatment groups
Timepoint [3] 0 0
Day 0, 6 weeks, 12 weeks, at end of consolidation (52 and 58 weeks) and at final outcomes at 56 weeks and 62 weeks
Secondary outcome [4] 0 0
Change in % Bronchiectasis scored using PRAGMA in chest CTs between Day 0 (screening) and at 12 weeks and at final outcome and between those who clear and those who do not clear MABS
Assessment method [4] 0 0
Change in % Bronchiectasis using PRAGMA CT between screening Day 0 and at 12 weeks and at final outcome
Timepoint [4] 0 0
Day 0 and 12 weeks and at final outcome at either 56 weeks or 62 weeks according to treatment path
Secondary outcome [5] 0 0
Change in % Air Trapping scored using PRAGMA in chest CTs between Day 0 (screening) and at 12 weeks and at final outcome and between those who clear and those who do not clear MABS
Assessment method [5] 0 0
Change in % Trapped Air using PRAGMA CT between screening Day 0 and at 12 weeks and at final outcome
Timepoint [5] 0 0
Day 0 and 12 weeks and at final outcome at either 56 weeks or 62 weeks according to treatment path
Secondary outcome [6] 0 0
Change in % Disease scored using PRAGMA in chest CTs between Day 0 (screening) and at 12 weeks and at final outcome and between those who clear and those who do not clear MABS
Assessment method [6] 0 0
Change in % Disease using PRAGMA CT between screening Day 0 and at 12 weeks and at final outcome
Timepoint [6] 0 0
Day 0 and 12 weeks and at final outcome at either 56 weeks or 62 weeks according to treatment path
Secondary outcome [7] 0 0
The predictive value of structural abnormalities at Day 0 (screening) CTs for sputum conversion and for progression of structural changes in relation to therapy.
Assessment method [7] 0 0
Association between structural abnormalities (%Bronchiectasis, %Air trapping and %Disease) at screening Day 0 and clearance of MABs at 12 weeks and at final outcome and with change in %Bronchiectasis, %Air trapping and %Disease between screening day 0 and at 12 weeks and at final outcome
Timepoint [7] 0 0
Day 0 and 12 weeks and at final outcome at either 56 weeks or 62 weeks according to treatment path
Secondary outcome [8] 0 0
The change in CFQ-R respiratory domain for those with CF between treatment groups for short intensive, prolonged intensive and consolidation phases as well as between Day 0 and final outcome and between participants with and without MABS clearance.
Assessment method [8] 0 0
The change in CFQ-R respiratory domain for patients with CF between baseline and at 6 weeks, 12 weeks and 56 weeks for those that had short intensive therapy and 62 weeks for those who received prolonged intensive therapy
Timepoint [8] 0 0
Day 0 and 6 weeks and 12 weeks, and at completion consolidation (at 52 and 58 weeks for those who completed short or prolonged IT) and at final outcome (at 56 and 62 weeks for those who completed short or prolonged IT)
Secondary outcome [9] 0 0
The change in HRQOL in adults, between treatment groups for short intensive, prolonged intensive and consolidation phases as well as between Day 0 and final outcome and between participants with and without MABS clearance.
Assessment method [9] 0 0
Change in HRQOL measured using the SF36
Timepoint [9] 0 0
Day 0 and 6 weeks and 12 weeks, and at completion consolidation (at 52 and 58 weeks for those who completed short or prolonged IT) and at final outcome (at 56 and 62 weeks for those who completed short or prolonged IT)
Secondary outcome [10] 0 0
The change in HRQoL in Children between treatment groups for short intensive, prolonged intensive and consolidation phases as well as between Day 0 and final outcome and between participants with and without MABS clearance.
Assessment method [10] 0 0
Change in HRQOL measured using the Peds-QL™
Timepoint [10] 0 0
Day 0 and 6 weeks and 12 weeks, and at completion consolidation (at 52 and 58 weeks for those who completed short or prolonged IT) and at final outcome (at 56 and 62 weeks for those who completed short or prolonged IT)
Secondary outcome [11] 0 0
The cost effectiveness of the proposed treatment combinations across both intensive and consolidation phases of the trial.
Assessment method [11] 0 0
Total cost between treatments calculated as the sum product of health resource utilisation and resource unit price during treatment period.
Timepoint [11] 0 0
from date of randomization for the duration of treatment up to 56 weeks for those allocated to short IT and up to 62 weeks for those allocated to prolonged IT
Secondary outcome [12] 0 0
The change in six minute walk distance for adult participants from the date of randomization to up to 62 weeks according to treatment path and in participants who do and do not clear MABS at time point final.
Assessment method [12] 0 0
Change in 6 minute walk distance using the six minute walk test in adult participants
Timepoint [12] 0 0
from date of randomization for the duration of treatment up to 56 weeks for those allocated to short IT and up to 62 weeks for those allocated to prolonged IT

Eligibility
Key inclusion criteria
Intervention Cohort

* Subjects with respiratory cultures positive for M. abscessus (MABS) (sub species abscessus, sub species bolletii, or subspecies massiliense) are required to meet all 3 American Thoracic Society criteria (clinical, radiological and microbiological) for MABS pulmonary disease (PD).
* Subjects with mixed NTM infections (slow growers + MABS) (adding ethambutol will be permitted if required by the treating physician).
* Willingness and ability to comply with trial regimens and the study visit requirements.

Intervention cohort
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Receiving active treatment for MABS within the previous 12 months, except azithromycin for participants with cystic fibrosis and bronchiectasis.
* Healthy volunteers may not participate.
* Pregnancy or planning to continue breastfeeding
* Known hypersensitivity to any of the therapies for which no alternate options(s) have been provided.

Observation Cohort Inclusion Criteria:

* At least one positive respiratory MABS culture
* Willingness and ability to comply with the study visit requirements.

Observation cohort Exclusion Criteria for:

* Receiving active treatment for MABS within the previous 12 months, except azithromycin for participants with cystic fibrosis and bronchiectasis.
* Healthy volunteers may not participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2030
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [9] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [10] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [11] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [12] 0 0
Greenslopes Private Hospital, - Greenslopes
Recruitment hospital [13] 0 0
Sir Charles Gairdiner Hospital - Nedlands
Recruitment hospital [14] 0 0
John Hunter Children's Hospital - New Lambton Heights
Recruitment hospital [15] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [16] 0 0
Perth Children's Hospital - Perth
Recruitment hospital [17] 0 0
The Alfred - Prahran
Recruitment hospital [18] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [19] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [20] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [21] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [22] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Kogarah
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment postcode(s) [7] 0 0
- Adelaide
Recruitment postcode(s) [8] 0 0
- Birtinya
Recruitment postcode(s) [9] 0 0
- Camperdown
Recruitment postcode(s) [10] 0 0
- Chermside
Recruitment postcode(s) [11] 0 0
- Gold Coast
Recruitment postcode(s) [12] 0 0
- Greenslopes
Recruitment postcode(s) [13] 0 0
- Nedlands
Recruitment postcode(s) [14] 0 0
- New Lambton Heights
Recruitment postcode(s) [15] 0 0
- New Lambton
Recruitment postcode(s) [16] 0 0
- Perth
Recruitment postcode(s) [17] 0 0
- Prahran
Recruitment postcode(s) [18] 0 0
- Randwick
Recruitment postcode(s) [19] 0 0
- South Brisbane
Recruitment postcode(s) [20] 0 0
- Sydney
Recruitment postcode(s) [21] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
København
Country [2] 0 0
Israel
State/province [2] 0 0
Beer-Sheeva
Country [3] 0 0
Israel
State/province [3] 0 0
Haifa
Country [4] 0 0
Israel
State/province [4] 0 0
Jerusalem
Country [5] 0 0
Israel
State/province [5] 0 0
Peta Tikva
Country [6] 0 0
Israel
State/province [6] 0 0
Ramat Gan Tel Aviv
Country [7] 0 0
Netherlands
State/province [7] 0 0
Rotterdam
Country [8] 0 0
Singapore
State/province [8] 0 0
Singapore
Country [9] 0 0
Taiwan
State/province [9] 0 0
Kaohsiung
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taipei
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Belfast
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Birmingham
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Bristol
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Cardiff
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Edinburgh
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Glasgow
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Liverpool
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Manchester
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Nottingham
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Penarth
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Southampton
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Wythenshawe

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Australian Government Department of Health and Ageing
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Children's Hospital Foundation
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cystic Fibrosis Foundation
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Newcastle University
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Griffith University
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Erasmus Medical Center
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Monash University
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
University of Copenhagen
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Hôpital Cochin
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
South Australian Health and Medical Research Institute
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
University of Melbourne
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
James Cook University, Queensland, Australia
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
Murdoch Childrens Research Institute
Country [13] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claire Wainwright, MD
Address 0 0
Country 0 0
Phone 0 0
+61730697322
Email 0 0
claire.wainwright@health.qld.gov.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04310930