300
Participants
Start Date
March 2, 2020
Primary Completion Date
June 30, 2029
Study Completion Date
June 30, 2030
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
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
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).
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.
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."
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
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.
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.
Amikacin
adult: Inhaled amikacin 500mg twice daily. Children: Inhaled amikacin 500mg twice daily
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."
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.
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.
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
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).
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
RECRUITING
Queensland Children's Hospital, South Brisbane
RECRUITING
Royal Perth Hospital, Perth
NOT_YET_RECRUITING
Tan Tock Seng Hospital Pte Ltd, Singapore
RECRUITING
St George Hospital, Kogarah
RECRUITING
Princess Alexandra Hospital, Woolloongabba
RECRUITING
Austin Hospital, Heidelberg
RECRUITING
Royal Melbourne Hospital, Parkville
RECRUITING
Royal Adelaide Hospital, Adelaide
RECRUITING
Sunshine Coast University Hospital, Birtinya
NOT_YET_RECRUITING
Royal Prince Alfred Hospital, Camperdown
RECRUITING
The Prince Charles Hospital, Chermside
RECRUITING
Gold Coast University Hospital, Gold Coast
RECRUITING
Greenslopes Private Hospital,, Greenslopes
RECRUITING
Sir Charles Gairdiner Hospital, Nedlands
NOT_YET_RECRUITING
John Hunter Hospital, New Lambton
NOT_YET_RECRUITING
John Hunter Children's Hospital, New Lambton Heights
RECRUITING
Perth Children's Hospital, Perth
RECRUITING
The Alfred, Prahran
NOT_YET_RECRUITING
Sydney Children's Hospital, Randwick
RECRUITING
Mater Adult Hospital, South Brisbane
NOT_YET_RECRUITING
Macquarie University Hospital, Sydney
NOT_YET_RECRUITING
The Children's Hospital at Westmead, Westmead
NOT_YET_RECRUITING
Westmead Hospital, Westmead
RECRUITING
Rigshospitalet, Copenhagen
NOT_YET_RECRUITING
Soroka Medical Centre, Beer-Sheeva
NOT_YET_RECRUITING
Carmel Medical Centre, Haifa
NOT_YET_RECRUITING
Rambam Health Care Campus, Haifa
NOT_YET_RECRUITING
Hadassah Ein Kerem Hospital, Jerusalem
NOT_YET_RECRUITING
Schneider, Petah Tikva
NOT_YET_RECRUITING
Sheba Medical Centre, Ramat Gan Tel Aviv
NOT_YET_RECRUITING
Erasmus MC Sophia Children's Hospital, Rotterdam
NOT_YET_RECRUITING
Kaohsiung Medical University Hospital, Kaohsiung City
NOT_YET_RECRUITING
National Taiwan University Hospital, Taipei
NOT_YET_RECRUITING
Belfast City Hospital, Belfast
NOT_YET_RECRUITING
Birmingham Children's Hospital, Birmingham
NOT_YET_RECRUITING
Birmingham Heartlands Hospital, Birmingham
NOT_YET_RECRUITING
Bristol Royal Hospital for Children, Bristol
NOT_YET_RECRUITING
Noah's Ark Childrens Hospital for Wales, Cardiff
NOT_YET_RECRUITING
Royal Hospital for Children and Young People, Edinburgh, Edinburgh
NOT_YET_RECRUITING
Western General Hospital, Edinburgh
NOT_YET_RECRUITING
Queen Elizabeth University Hospital, Glasgow, Glasgow
NOT_YET_RECRUITING
Alder Hey Children NHS Foundation Trust, Liverpool
NOT_YET_RECRUITING
Royal Brompton Hosptial, London
NOT_YET_RECRUITING
Royal Manchester Children's Hospital, Manchester
NOT_YET_RECRUITING
Nottingham Children's Hosptial, Nottingham
NOT_YET_RECRUITING
Queens Medical Centre, Nottingham
NOT_YET_RECRUITING
Welcome Wolfson Adult CF Centre (City Hospital Campus), Nottingham
NOT_YET_RECRUITING
University Hospital Llandough, Penarth
NOT_YET_RECRUITING
Southampton General Hospital, Southampton
NOT_YET_RECRUITING
Wythenshawe Hospital, Wythenshawe
Collaborators (2)
Australian Government Department of Health and Ageing
OTHER_GOV
Children's Hospital Foundation
OTHER
Cystic Fibrosis Foundation
OTHER
Newcastle University
OTHER
Griffith University
OTHER
Erasmus Medical Center
OTHER
Monash University
OTHER
University of Copenhagen
OTHER
South Australian Health and Medical Research Institute
OTHER
University of Melbourne
OTHER
Murdoch Childrens Research Institute
OTHER
QIMR Berghofer Medical Research Institute
OTHER
The University of Queensland
OTHER