Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

NCT07485010 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FORMaT002
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if a new combination antibiotic treatment (Arm D) works to treat a rare lung condition called mycobacterium abscessus pulmonary disease in people of any age and sex, when compared to the standard treatments. It will also learn about the safety of this new combination antibiotic treatment when compared to the standard treatments. The main questions it aims to answer are:

• How well does Arm D treat mycobacterium abscessus pulmonary disease?
• What side effects does Arm D cause when used to treat mycobacterium abscessus pulmonary disease? Researchers will compare Arm D to the current standard of care treatments to see if Arm D treats mycobacterium abscessus pulmonary disease better and if it will cause less side effects. Participants will:
• Be screened and recruited to the FORMaT adaptive platform trial (NCT04310930)
• Be given Arm D for 4 weeks or standard of care treatments for 6 weeks.
• Be reviewed by the study doctors weekly for checkups and tests.
• Provide respiratory samples (sample coughed up from the chest), respond to quality-of-life questionnaires, have CT lung scans and blood tests.

Conditions

Mycobacterium Abscessus Pulmonary Disease; Mycobacterium Abscessus Infection; Non-Tuberculous Mycobacterial (NTM) Infections; Non-Tuberculous Mycobacteria Pulmonary Disease

Keywords

adaptive platform trial; dual beta lactam; sulbactam-durlobactam

Outcome Measures

Primary Outcomes (3)

• The primary outcome of the Intervention Program is microbiological clearance of Mycobacterium abscessus (MABS) with good tolerance of the interventions.

  Definition of MABS clearance at final outcome: Negative MABS cultures from four consecutive sputum samples with one of those sputum specimens collected four weeks after the completion of consolidation therapy, or a MABS negative Bronchoalveolar Lavage (BAL) collected four weeks after completion of consolidation. Definition of tolerance: Tolerance is based on the Common Terminology Criteria for Adverse Events (CTCAE version 5.0). Only adverse events that are attributed as either "possibly-", "probably-", or "definitely-" related to study drug will be assessed in the determination of tolerance. "Good" tolerance is defined as no adverse events occurring or only adverse events coded as CTCAE grades 1 and 2. "Poor" tolerance is defined as any adverse events attributed as possibly-, probably-, or definitely-related to study drug coded as CTCAE grades 3, 4, or 5.

  Screening (Day 0) to End of treatment plus four weeks off-treatment (Final Outcome Visit (Week 56 for those allocated to Immediate Consolidation or Week 62 for those allocated to Prolonged Intensive).

• Nested Study A3.1 Type of Short Intensive Therapy - MABS clearance from respiratory sample(s) with tolerance.

  Microbiological clearance of MABS from respiratory samples collected at 4 weeks with good tolerability assessed at the end of short intensive therapy between Arm D and the standard of care arms given during intensive phase. Definition of MABS clearance is 3 MABS negative sputum samples or ONE MABS negative Bronchoalveolar Lavage (BAL) at end of Short Intensive Therapy. Treatment tolerance is defined as no Treatment emergent adverse events and/or Treatment emergent adverse events that are "possibly-", "probably-", or "definitely-" related to study drug and coded as grade 1 or 2 based on the CTCAEv5.0.

  Screening (Day 0) to the End of Short Intensive Therapy (Week 6).

• Nested Study A3.2 - Duration of intensive therapy for patients completing short intensive treatment with ongoing positive MABS cultures collected at 4 weeks and randomised to either a further 6 weeks intensive therapy or immediate consolidation.

  To compare the microbiological clearance from samples collected at 10 weeks with good tolerability between those who are allocated to prolonged intensive therapy and those allocated to immediate consolidation following short intensive therapy. MABS clearance, assessed at the end of prolonged intensive therapy (for those allocated to prolonged intensive) or at 12 weeks (for those allocated to immediate consolidation) will be defined as negative MABS cultures from all 3 sputum samples or from one BAL sample collected at 10 weeks. "Good" tolerance is defined as no adverse events occurring or only adverse events that are attributed as either "possibly-", "probably-", or "definitely-" related to study drug coded as CTCAE grades 1 and 2.

  Screening (Day 0) to EITHER the End of Prolonged Intensive Therapy (for those allocated to Prolonged Intensive) OR Week 12 Visit (for those allocated to immediate consolidation therapy).

Secondary Outcomes (16)

• Probability of MABS clearance at Final Outcome irrespective of toxicity according to participant's treatment pathway.

  Screening (Day 0); at End of Treatment plus 4 weeks off treatment (Final Outcome Visit - either Week 56 or Week 62).

• Incidence of Treatment emergent adverse events

  Screening (Day 0); At End of Short Intensive Therapy (Week 6); At End of Prolonged Intensive Therapy OR at Week 12 visit; at End of Treatment plus 4 weeks off treatment (Final Outcome Visit - either Week 56 or Week 62).

• Safety of treatments based on changes in microbiological resistance.

  Screening (Day 0); At End of Short Intensive Therapy (Week 6); At End of Prolonged Intensive Therapy OR at Week 12 visit; at End of Treatment plus 4 weeks off treatment (Final Outcome Visit - either Week 56 or Week 62).

• Change in Forced Expiratory Volume in 1 second (FEV1) z-score at Final Outcome compared with Screening in participants who do and do not clear MABS at Final Outcome.

  Screening (Day 0); At End of Short Intensive Therapy (Week 6); At End of Prolonged Intensive Therapy OR at Week 12 visit; at End of Treatment plus 4 weeks off treatment (Final Outcome Visit - either Week 56 or Week 62).

• Phenotype of the structural abnormalities of chest Computer Tomography (CT) and changes in chest CT scores between Screening and Final Outcome between participants who clear or do not clear MABS at Final Outcome.

  Screening (Day 0); At End of Prolonged Intensive Therapy OR at Week 12 visit; at End of Treatment plus 4 weeks off treatment (Final Outcome Visit - either Week 56 or Week 62).

Other Outcomes (1)

• Participant's MABS clearance status 12 months after Final Outcome.

  12 months after End of Treatment plus 4 weeks off treatment (Final Outcome Visit).

Study Arms (6)

Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

EXPERIMENTAL

Weeks 1 to 4 (and Weeks 7 to 10 if randomised to Prolonged Intensive) 1. IV sulbactam-durlobactam 2. IV ceftriaxone 3. Oral amoxicillin 4. Oral azithromycin or clarithromycin 5. Oral clofazimine. Weeks 5 to 6 (and Weeks 8 to 12 if randomised to Prolonged Intensive) 1\. Oral clofazimine, and; 2. Oral azithromycin or clarithromycin, and; 3. In combination with one to three of the following oral antibiotics guided by participant susceptibility and tolerance: * Linezolid, * Trimethoprim / sulfamethoxazole (co-trimoxazole), * Bedaquiline, * Rifabutin, * Doxycycline, * Moxifloxacin.

Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours); Drug: Ceftriaxone for Injection; Drug: Amoxicillin; Drug: Azithromcyin; Drug: clarithromycin; Drug: Clofazimine; Drug: Ethambutol; Drug: linezolid; Drug: Trimethoprim / Sulfamethoxazole; Drug: Doxycycline; Drug: moxifloxacin; Drug: bedaquiline; Drug: Rifabutin

Intensive Arm A with IV amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine

ACTIVE COMPARATOR

1. IV amikacin, and; 2. IV tigecycline, and; 3. IV imipenem/cilastatin or IV cefoxitin, and; 4. Oral azithromycin or oral clarithromycin, and; 5. Oral clofazimine. Administered for a duration of 6 weeks for Short Intensive Therapy or 12 weeks for Prolonged Intensive Therapy.

Drug: Azithromcyin; Drug: clarithromycin; Drug: Clofazimine; Drug: Ethambutol; Drug: Amikacin Injection; Drug: tigecycline; Drug: Imipenem + Cilastatin; Drug: Cefoxitin

Intensive Arm B with Inhaled Amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine

EXPERIMENTAL

1. Inhaled amikacin, and; 2. IV tigecycline, and; 3. IV imipenem/cilastatin or IV cefoxitin, and; 4. Oral azithromycin or oral clarithromycin, and; 5. Oral clofazimine. Administered for a duration of 6 weeks for Short Intensive Therapy or 12 weeks for Prolonged Intensive Therapy.

Drug: Azithromcyin; Drug: clarithromycin; Drug: Clofazimine; Drug: Ethambutol; Drug: tigecycline; Drug: Imipenem + Cilastatin; Drug: Cefoxitin; Drug: Amikacin (Inhalation)

Intensive Arm C with IV amikacin, imipenem or cefoxitin, tigecycline and macrolide

EXPERIMENTAL

1. IV amikacin, and; 2. IV tigecycline, and; 3. IV imipenem/cilastatin or IV cefoxitin, and; 4. Oral azithromycin or oral clarithromycin. Administered for a duration of 6 weeks for Short Intensive Therapy or 12 weeks for Prolonged Intensive Therapy.

Drug: Azithromcyin; Drug: clarithromycin; Drug: Ethambutol; Drug: Amikacin Injection; Drug: tigecycline; Drug: Imipenem + Cilastatin; Drug: Cefoxitin

Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents

ACTIVE COMPARATOR

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. For 46 weeks after completion of Intensive Therapy phase.

Drug: Azithromcyin; Drug: clarithromycin; Drug: Clofazimine; Drug: Ethambutol; Drug: linezolid; Drug: Trimethoprim / Sulfamethoxazole; Drug: Doxycycline; Drug: moxifloxacin; Drug: bedaquiline; Drug: Rifabutin

Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents

EXPERIMENTAL

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. For 46 weeks after completion of Intensive Therapy phase.

Drug: Azithromcyin; Drug: clarithromycin; Drug: Clofazimine; Drug: Ethambutol; Drug: Amikacin (Inhalation); Drug: linezolid; Drug: Trimethoprim / Sulfamethoxazole; Drug: Doxycycline; Drug: moxifloxacin; Drug: bedaquiline; Drug: Rifabutin

Interventions

Cefoxitin DRUG

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.

Intensive Arm A with IV amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm B with Inhaled Amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm C with IV amikacin, imipenem or cefoxitin, tigecycline and macrolide

Amikacin (Inhalation) DRUG

Adult: Inhaled amikacin 500mg twice daily. Children: Inhaled amikacin 500mg twice daily. PLEASE NOTE: low preservative intravenous amikacin preparation to be used as inhalation, NOT liposomal amikacin.

Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents; Intensive Arm B with Inhaled Amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine

linezolid DRUG

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: \>12 years 600mg once daily.

Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents; Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents; Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

Trimethoprim / Sulfamethoxazole DRUG

Adults and children 12 years and older: Oral Co-trimoxazole (Trimethoprim / Sulfamethoxazole) 160/800mg twice daily.

Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents; Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents; Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

Doxycycline DRUG

Adults and Children 12 years and older: Oral doxycycline 100mg once daily.

Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents; Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents; Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours) DRUG

Adults and Children 12 years and older: IV sulbactam/durlobactam Greater than or equal to 130ml/min Every FOUR (4) hourly. Administered by intravenous infusion over 3 hours. For CrCL 45 to 129ml/min 1g sulbactam/ 1g durlobactam Every SIX (6) hourly. Administer by intravenous infusion over 3 hours. For CrCL 30 to 44ml/min 1g sulbactam/ 1g durlobactam Every EIGHT (8) hourly. Administer by intravenous infusion over 3 hours. For CrCL 15 to 29ml/min 1g sulbactam/ 1g durlobactam Every TWELVE (12) hourly. Administer by intravenous infusion over 3 hours. For CrCL\<15ml/min 1g sulbactam/ 1g durlobactam Every TWELVE (12) hourly for first 3 doses then reduce to every 24 hourly thereafter. Administer by intravenous infusion over 3 hours.

Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

Ceftriaxone for Injection DRUG

Adults and Children 12 years and older: IV ceftriaxone 1g Every TWELVE (12) hourly

Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

Amoxicillin DRUG

Adults and Children 12 years and older: Oral amoxicillin 1000mg Three times daily

Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

Azithromcyin DRUG

Adults and Children 12 years and older: Oral Azithromycin 250 - 500mg Once daily If \<40kg or poorly tolerated 250mg Once daily

Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents; Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents; Intensive Arm A with IV amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm B with Inhaled Amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm C with IV amikacin, imipenem or cefoxitin, tigecycline and macrolide; Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

clarithromycin DRUG

Oral clarithromycin. Only for use if azithromycin not tolerated. Adults: 500mg twice daily. Children: 12-18 years of age: Dosing independent of weight 500mg twice daily

Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents; Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents; Intensive Arm A with IV amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm B with Inhaled Amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm C with IV amikacin, imipenem or cefoxitin, tigecycline and macrolide; Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

Clofazimine DRUG

Adults and Children 12 years and older: Oral clofazimine 100mg to 300mg Once daily

Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents; Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents; Intensive Arm A with IV amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm B with Inhaled Amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

Ethambutol DRUG

For participants with confirmed mixed NTM (slow growers + MABS) infections, there is an option to add oral ethambutol to the treatment arm in accordance with the dosing below. Oral ethambutol 15mg/kg (rounded to account for tablet strength) OR Once daily 25mg/kg (rounded to account for tablet strength) Thrice weekly

Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents; Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents; Intensive Arm A with IV amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm B with Inhaled Amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm C with IV amikacin, imipenem or cefoxitin, tigecycline and macrolide; Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

Amikacin Injection DRUG

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

Intensive Arm A with IV amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm C with IV amikacin, imipenem or cefoxitin, tigecycline and macrolide

tigecycline DRUG

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

Intensive Arm A with IV amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm B with Inhaled Amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm C with IV amikacin, imipenem or cefoxitin, tigecycline and macrolide

Imipenem + Cilastatin DRUG

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).

Intensive Arm A with IV amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm B with Inhaled Amikacin, imipenem or cefoxitin, tigecycline, macrolide and clofazimine; Intensive Arm C with IV amikacin, imipenem or cefoxitin, tigecycline and macrolide

moxifloxacin DRUG

Adult: Oral moxifloxacin 400mg once daily. Children 12 years and older: Oral moxifloxacin 10-15mg/kg once daily, maximum dose 400mg

Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents; Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents; Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

bedaquiline DRUG

Adult: 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).

Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents; Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents; Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

Rifabutin DRUG

Adult: Oral rifabutin: 5mg/kg once daily, maximum 300-450mg. Children 12 years and older: Oral rifabutin 5mg/kg once daily

Consolidation arm a with clofazimine, macrolide and a combination of 1 to 3 oral antibiotic agents; Consolidation arm b with inhaled amikacin, clofazimine, macrolide and 1 to 3 oral antibiotic agents; Intensive Arm D with Sulbactam-Durlobactam in a combination antibiotic regimen

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 12 years and older.

You may not qualify if:

• Participants aged \<12 years old.
• Participants aged between 12 and \<18years old with clinically significant renal impairment as indicated by an age-appropriate estimated creatinine clearance.
• Known hypersensitivity to any of the therapies for which no alternative option(s) have been provided. This includes:
• Sulbactam/durlobactam
• Ceftriaxone,
• Amoxicillin,
• Macrolide antibiotics, and
• Clofazimine.

Sponsors & Collaborators

• The University of Queensland: lead
• Innoviva Specialty Therapeutics: collaborator

MeSH Terms

Conditions

Mycobacterium Infections, Nontuberculous; Infections

Interventions

Sulbactam; durlobactam; Ceftriaxone; Injections; Amoxicillin; Clarithromycin; Clofazimine; Ethambutol; Amikacin; Tigecycline; Cilastatin, Imipenem Drug Combination; Cefoxitin; Inhalation; Linezolid; Trimethoprim, Sulfamethoxazole Drug Combination; Doxycycline; Moxifloxacin; bedaquiline; Rifabutin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cefotaxime; Cephacetrile; Cephalosporins; Thiazines; Drug Administration Routes; Drug Therapy; Therapeutics; Ampicillin; Penicillin G; Erythromycin; Macrolides; Polyketides; Lactones; Phenazines; Heterocyclic Compounds, 3-Ring; Ethylenediamines; Diamines; Polyamines; Amines; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Imipenem; Thienamycins; Carbapenems; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Drug Combinations; Pharmaceutical Preparations; Cephamycins; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Acetamides; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Benzene Derivatives; Sulfones; Trimethoprim; Pyrimidines; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds

Central Study Contacts

Claire Wainwright Chief Investigator, MD

CONTACT

+61730697322; claire.wainwright@health.qld.gov.au

Tiffany Jong Project Manager, BPharm

CONTACT

+61730697620; formattrial@health.qld.gov.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 20, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR