Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

March 2, 2020

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2030

Conditions
Pulmonary Disease Due to Mycobacteria (Diagnosis)
Interventions
DRUG

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

DRUG

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

DRUG

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).

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.

DRUG

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."

DRUG

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

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.

DRUG

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.

DRUG

Amikacin

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

DRUG

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."

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.

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.

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

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).

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

Trial Locations (50)

4101

RECRUITING

Queensland Children's Hospital, South Brisbane

6000

RECRUITING

Royal Perth Hospital, Perth

308433

NOT_YET_RECRUITING

Tan Tock Seng Hospital Pte Ltd, Singapore

Unknown

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

All Listed Sponsors
collaborator

Australian Government Department of Health and Ageing

OTHER_GOV

collaborator

Children's Hospital Foundation

OTHER

collaborator

Cystic Fibrosis Foundation

OTHER

collaborator

Newcastle University

OTHER

collaborator

Griffith University

OTHER

collaborator

Erasmus Medical Center

OTHER

collaborator

Monash University

OTHER

collaborator

University of Copenhagen

OTHER

collaborator

South Australian Health and Medical Research Institute

OTHER

collaborator

University of Melbourne

OTHER

collaborator

Murdoch Childrens Research Institute

OTHER

collaborator

QIMR Berghofer Medical Research Institute

OTHER

lead

The University of Queensland

OTHER

NCT04310930 - Finding the Optimal Regimen for Mycobacterium Abscessus Treatment | Biotech Hunter | Biotech Hunter