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New treatment option for Pulmonary Disease Due to Mycobacteria (Diagnosis)
Official title Finding the Optimal Regimen for Mycobacterium Abscessus Treatment
ClinicalTrials.gov ID: NCT04310930
What this study is testing
What is Amikacin?
Amikacin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for pulmonary disease due to mycobacteria (diagnosis).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Eligibility criteria for the FORMaT trial can be applied at two levels:
- Eligibility into the Intervention Program, or;
- Eligibility into the Observational Cohort. Potential participants can only be enrolled in either the Intervention Program or the Observational Cohort...
- Enrol directly into the Intervention Program, or;
- Enrol into the Observational Cohort and transition into the Intervention Program once they satisfy the for this program which can occur at any time...
You likely can't join if
- listed below. For eligible participants with mixed NTM infections additional therapy combinations are available as detailed in the relevant...
- Positive MABS-PD diagnosis meeting all three American Thoracic Society clinical, radiological and microbiological diagnostic criteria for MABS-PD...
- Clinical: Pulmonary symptoms and exclusion of other diagnoses.
- Radiological: Nodular or cavitary opacities on chest radiograph or a chest high-resolution computed tomography (HRCT) scan showing multifocal...
- Microbiological: MABS positive culture results from at least two separate expectorated sputum samples. or Positive culture results from at least one...
- Male or female participants of any age.
See the full eligibility criteria
- Eligibility criteria for the FORMaT trial can be applied at two levels:
- Eligibility into the Intervention Program, or;
- Eligibility into the Observational Cohort. Potential participants can only be enrolled in either the Intervention Program or the Observational Cohort at any one time. Provided the eligibility criteria are met, potential...
- Enrol directly into the Intervention Program, or;
- Enrol into the Observational Cohort and transition into the Intervention Program once they satisfy the for this program which can occur at any time during the trial. Eligibility into the FORMaT trial will be assessed at...
- listed below. For eligible participants with mixed NTM infections additional therapy combinations are available as detailed in the relevant appendices. INTERVENTION PROGRAM INCLUSION CRITERIA
- Positive MABS-PD diagnosis meeting all three American Thoracic Society clinical, radiological and microbiological diagnostic criteria for MABS-PD. Defined as:
- Clinical: Pulmonary symptoms and exclusion of other diagnoses.
- Radiological: Nodular or cavitary opacities on chest radiograph or a chest high-resolution computed tomography (HRCT) scan showing multifocal bronchiectasis with multiple small nodules.
- Microbiological: MABS positive culture results from at least two separate expectorated sputum samples. or Positive culture results from at least one bronchial wash or lavage. or Transbronchial or other lung biopsy with...
- Male or female participants of any age.
- Participant has not received treatment for MABS-PD in the 12 months preceding assessment of eligibility or as specified in the relevant appendix (this includes drugs prescribed for the treatment of other mycobacteria...
- Informed consent signed by participant or parent/legal guardian if participant is under 18 years of age.
- Ability to comply with study visits, therapies and study procedures as judged by the site investigator. INTERVENTION PROGRAM EXCLUSION CRITERIA
- Participants receiving current treatment for MABS (this includes drugs prescribed for the treatment of other mycobacteria and/or other indications that may have activity against MABS, as specified in the FORMaT...
- Participants who have a QTc interval of \>500 milliseconds (QT interval corrected based on Fridericia method).
- Participants who are pregnant or planning to continue breast feeding.
- Known hypersensitivity or contraindication to any of the therapies for which no alternative option(s) have been provided. OBSERVATIONAL COHORT INCLUSION CRITERIA To be eligible to participate in the Observational Cohort...
- Male and female participants of any age with at least one positive respiratory culture for MABS.
- Informed consent signed by participant or parent/legal guardian if participant is under 18 years of age.
- Ability to comply with study visits and study procedures as judged by the site investigator. OBSERVATIONAL COHORT EXCLUSION CRITERIA Potential participants will be ineligible to participate in the Observational Cohort...
- Receiving active treatment for MABS within the previous 12 months (this includes drugs prescribed for the treatment of other mycobacteria and/or other indications that may have activity against MABS, as specified in the...
The study team makes the final eligibility decision.
Where it's taking place
- Kogarah, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Heidelberg, Victoria, Australia
- Parkville, Victoria, Australia
- Perth, Western Australia, Australia
- Adelaide, Australia
- Birtinya, Australia
- Camperdown, Australia
- Chermside, Australia
- Gold Coast, Australia
- Greenslopes, Australia
- Nedlands, Australia
- New Lambton, Australia
- New Lambton Heights, Australia
- Perth, Australia
- Prahran, Australia
- Randwick, Australia
- South Brisbane, Australia
- Sydney, Australia
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kogarah, New South Wales, Australia; South Brisbane, Queensland, Australia; Woolloongabba, Queensland, Australia; Heidelberg, Victoria, Australia; Parkville, Victoria, Australia; Perth, Western Australia, Australia and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.