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Antibiotic
Optimal Drug Regimen for Lung Disease (FORMaT Trial)
Phase 2 & 3
Recruiting
Research Sponsored by The University of Queensland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post trial completion
Awards & highlights
Summary
This trial tests different medicine combinations to find the best way to treat a tough lung infection in children and adults. The goal is to find the safest and most effective treatment.
Who is the study for?
This trial is for people with a lung condition caused by Mycobacterium abscessus, who meet specific clinical, radiological, and microbiological criteria. It's open to those with mixed infections if needed for treatment. Participants must be able to follow the trial plan and visit schedule. Those treated for MABS in the last year (except certain cases), pregnant or breastfeeding individuals, or anyone allergic to the drugs tested cannot join.
What is being tested?
The FORMaT trial is testing a combination of antibiotics including Cefoxitin, Linezolid, Bedaquiline and others against MABS pulmonary disease. The goal is to find the best treatment regimen that maximizes health outcomes while minimizing toxicity and burden on patients.
What are the potential side effects?
Potential side effects from these antibiotics may include allergic reactions, gastrointestinal issues like nausea or diarrhea, changes in blood counts leading to anemia or increased infection risk, liver toxicity, nerve damage causing numbness or pain, and possibly hearing loss due to Amikacin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with M. abscessus lung disease based on clinical, radiological, and microbiological criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post trial completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post trial completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Appendix A1 - MABS clearance from respiratory samples with tolerance at final outcome
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
Nested Study A1.1 Short Intensive Therapy - MABS Clearance
+3 moreSecondary outcome measures
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
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
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
+9 moreOther outcome measures
Examine the MABS clearance status at twelve (12 months) after time point final
Side effects data
From 2018 Phase 4 trial • 190238 Patients • NCT020479813%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Biannual Mass Oral Azithromycin
Biannual Mass Oral Placebo
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Intensive Therapy CExperimental Treatment7 Interventions
Following Randomisation 1, Participants will receive intensive drug therapy in the form of IV amikacin, IV tigecycline, IV cefoxitin/imipenem + oral azithromycin/oral clarithromycin.
Group II: Intensive Therapy BExperimental Treatment8 Interventions
Following Randomisation 1, Participants will receive inhaled amikacin (IA), IV tigecycline, IV cefoxitin/imipenem + oral azithromycin/oral clarithromycin AND clofazimine.
Group III: Consolidation BExperimental Treatment11 Interventions
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.
Group IV: Consolidation AActive Control10 Interventions
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.
Group V: Intensive Therapy AActive Control8 Interventions
Following Randomisation 1, Participants will receive intensive drug therapy in the form of IV amikacin, IV tigecycline, IV cefoxitin/imipenem + oral azithromycin AND clofazimine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amikacin
2016
Completed Phase 4
~540
Bedaquiline
2020
Completed Phase 3
~3900
Tigecycline
2008
Completed Phase 4
~2270
Imipenem
2018
Completed Phase 4
~830
Azithromycin
2018
Completed Phase 4
~274950
Clarithromycin
2017
Completed Phase 4
~3950
Clofazimine
2022
Completed Phase 4
~2900
Ethambutol
2023
Completed Phase 4
~3090
Linezolid
2002
Completed Phase 4
~3890
co-trimoxazole
2013
Completed Phase 2
~20
Rifabutin
2003
Completed Phase 4
~890
Doxycycline
2008
Completed Phase 4
~2430
Moxifloxacin
2013
Completed Phase 4
~3290
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for tuberculosis (TB) include isoniazid, rifampin, ethambutol, and pyrazinamide. Isoniazid inhibits the synthesis of mycolic acids, essential components of the mycobacterial cell wall.
Rifampin targets bacterial RNA polymerase, thereby inhibiting RNA synthesis. Ethambutol interferes with the synthesis of the mycobacterial cell wall by inhibiting arabinosyl transferases.
Pyrazinamide disrupts mycobacterial cell membrane metabolism and transport functions. Understanding these mechanisms is crucial for TB patients as it helps in designing optimized treatment regimens that maximize efficacy while minimizing toxicity, thereby improving health outcomes and reducing the burden of side effects.
Adult systemic anaplastic large-cell lymphoma: recommendations for diagnosis and management.Impact of patient characteristics and infection type on clinical outcomes of patients who received linezolid or vancomycin for complicated skin and skin structure infections caused by methicillin-resistant Staphylococcus aureus: a pooled data analysis.Virological treatment failure of protease inhibitor therapy in an unselected cohort of HIV-infected patients.
Adult systemic anaplastic large-cell lymphoma: recommendations for diagnosis and management.Impact of patient characteristics and infection type on clinical outcomes of patients who received linezolid or vancomycin for complicated skin and skin structure infections caused by methicillin-resistant Staphylococcus aureus: a pooled data analysis.Virological treatment failure of protease inhibitor therapy in an unselected cohort of HIV-infected patients.
Find a Location
Who is running the clinical trial?
The University of QueenslandLead Sponsor
140 Previous Clinical Trials
67,456 Total Patients Enrolled
Monash UniversityOTHER
190 Previous Clinical Trials
10,586,982 Total Patients Enrolled
Hôpital CochinOTHER
27 Previous Clinical Trials
16,008 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken MABS treatment in the last year, except azithromycin for my cystic fibrosis.I have been diagnosed with M. abscessus lung disease based on clinical, radiological, and microbiological criteria.I have a mixed NTM infection and may need ethambutol as decided by my doctor.You are allergic to the treatment options available for this study.You have at least one positive culture for bacteria in your respiratory system.I am willing and able to follow the trial's treatment plan and attend all study visits.
Research Study Groups:
This trial has the following groups:- Group 1: Intensive Therapy B
- Group 2: Consolidation A
- Group 3: Intensive Therapy A
- Group 4: Intensive Therapy C
- Group 5: Consolidation B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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