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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

FORMaT Trial Summary

This trial is studying the best treatment regimens for mycobacterium abscessus pulmonary disease, a lung infection. The goal is to find regimens that maximise health outcomes, minimise toxicity and treatment burden, and develop biomarkers to guide decisions for starting treatment and measuring disease severity.

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.Check my eligibility

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.See study design

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.

FORMaT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with M. abscessus lung disease based on clinical, radiological, and microbiological criteria.

FORMaT Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post trial completion for reporting.

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 more

Secondary 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 more

Other 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 • NCT02047981

Death

100%

80%

60%

40%

20%

Study treatment Arm

Biannual Mass Oral Placebo

Biannual Mass Oral Azithromycin

FORMaT 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

~3350

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

~2340

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of QueenslandLead Sponsor

140 Previous Clinical Trials

65,916 Total Patients Enrolled

Monash UniversityOTHER

187 Previous Clinical Trials

10,486,291 Total Patients Enrolled

Hôpital CochinOTHER

27 Previous Clinical Trials

16,008 Total Patients Enrolled

Media Library

Amikacin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04310930 — Phase 2 & 3

Tuberculosis Research Study Groups: Intensive Therapy B, Consolidation A, Intensive Therapy A, Intensive Therapy C, Consolidation B

Tuberculosis Clinical Trial 2023: Amikacin Highlights & Side Effects. Trial Name: NCT04310930 — Phase 2 & 3

Amikacin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04310930 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any positions left for volunteers in this experiment?

"Yes, this information can be found on clinicaltrials.gov. The listing for this study says that it is actively recruiting, with the first posting on March 2nd, 2020 and the most recent update on September 12th, 2020."

Answered by AI

What are the goals that participants in this trial are hoping to achieve?

"The aim of this clinical trial, which will take 4 weeks to collect samples and 6 weeks to culture, is to study the efficacy of clofazimine during short intensive therapy. Additionally, this trial hopes to understand the predictive value of structural abnormalities at Day 0 for sputum conversion and for progression of structural changes in relation to therapy. Furthermore, this study will compare 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. Additionally, this trial aims to understand the difference in total cost over"

Answered by AI

What are the primary infections that Azithromycin is used to fight?

"Azithromycin is most effective in treating q fever, but it can also help patients with severe acne, communicable diseases, and genus chlamydia."

Answered by AI

Could you please provide more information on other clinical trials that have used Azithromycin?

"Currently, 193 clinical trials are underway to investigate the efficacy of azithromycin. 55 of those trials are in their final stage of testing. The majority of trials for azithromycin are based in Chiayi, Hessen, but there are 1,602 locations running trials for this treatment."

Answered by AI