Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
300
Countries
1
Sites
1
Mycobacterium abscessus pulmonary disease
Primary Outcome The primary outcome of the Intervention Program is microbiological clearance of 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 comp…
Key facts
- Sponsor
- The University Of Queensland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 2 Jan 2023 → ongoing
- Decision date (initial)
- 2023-07-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Anonymous Donor (Private Person) · Children's Hospital Foundation · Medical Research Future Fund · University of Queensland · Cystic Fibrosis Foundation · Thoracic Society of Australia and New Zealand
External identifiers
- EU CT number
- 2023-506575-99-00
- EudraCT number
- 2020-000050-10
- ClinicalTrials.gov
- NCT04310930
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Primary Outcome
The primary outcome of the Intervention Program is microbiological clearance of 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.
Secondary objectives 6
- 1. To investigate the optimal approaches to antibiotic dosing and therapeutic drug monitoring.
- 2. To investigate the health-related quality of life and cost effectiveness of proposed therapy combinations.
- 3. To examine changes in clinical markers such as chest imaging and lung function to predict the onset of MABS-PD a
- 4. To develop biomarkers to predict the onset of MABS-PD and response to therapies.
- 5. To understand susceptibility to infection with MABS associated with the development of MABS-PD and host immune responses to infection and with treatment.
- 6. To characterise the genomics of human MABS strains and antibiotic resistance genes in patients in the observation and intervention studies.
Conditions and MedDRA coding
Mycobacterium abscessus pulmonary disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10064789 | Mycobacterium abscessus infection | 100000004862 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomisation 1 - Intensive Therapy At Randomisation 1, participants will be randomised to one of three treatment arms during the intensive phase and will receive drug therapy in accordance with the dosing tables in the relevant appendix. Drug therapy, administration and duration is dependent on the treatment arm (Intensive A, Intensive B, Intensive C) the participant is randomised to.
|
Randomised Controlled | None | Intensive Arm A: Comparator Arm 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 Intensive Arm B: Test arm - Use of inhaled amikacin during intensive therapy to replace intravenous amikacin in the treatment of MABS-PD 1. Inhaled amikacin, and; 2. IV tigecycline, and; 3. IV imipenem/cilastatin or cefoxitin, and; 4. Oral azithromycin or oral clarithromycin, and; 5. Oral clofazimine. Intensive Arm C: Test arm - Use of additional clofazimine to standard intravenous therapies during intensive therapy in the treatment of MABS-PD. 1. IV amikacin, and; 2. IV tigecycline, and; 3. IV imipenem/cilastatin or IV cefoxitin, and; 4. Oral azithromycin or oral clarithromycin. |
|
| 2 | Randomisation 2 - Duration of Intensive Therapy for Patients with Ongoing Positive MABS cultures Randomisation 2 will ONLY be for participants who are still MABS positive at week six and will allocate participants to either 1) continue intensive therapy or 2) immediately commence consolidation therapy.
|
Randomised Controlled | None | Prolonged Intensive: If randomised to prolonged intensive the participant will complete another six weeks of intensive therapy. Immediate Consolidation: If randomised to immediate consolidation the participant will proceed to randomisation 3 and commence consolidation therapy. |
|
| 3 | Randomisation 3 - Consolidation Therapy Allocates participants to the consolidation therapy arms either at week 6 or at week 12 depending on MABS clearance. This module looks at the use of oral therapy only or oral therapy and inhaled amikacin for Consolidation Therapy. Following Randomisation 3, participants will receive consolidation treatment in accordance with the dosing tables included in the FORMaT Trial Master Protocol and Appendices. Drug therapy, administration and duration is dependent on the treatment arm (Consolidation Arm a and Consolidation Arm b), age, and/or weight of the participant.
|
Randomised Controlled | None | Consolidation Arm a: 1. Oral clofazimine, and; 2. Oral azithromycin or oral clarithromycin, and; In combination with one to three of the following oral antibiotics: - Oral linezolid - Oral trimethoprim/sulfamethoxazole - Oral bedaquiline - Oral rifabutin - Oral doxycycline - Oral moxifloxacin Consolidation Arm b: 1. Inhaled amikacin, and; 2. Oral clofazimine, and; 3. Oral azithromycin or oral clarithromycin, and; In combination with one to three of the following oral antibiotics: - Oral linezolid - Oral trimethoprim/sulfamethoxazole - Oral bedaquiline - Oral rifabutin - Oral doxycycline - Oral moxifloxacin |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Positive MABS-PD diagnosis meeting all three American Thoracic Society clinical, radiological and microbiological diagnostic criteria for MABS-PD. Defined as: a. Clinical: Pulmonary symptoms and exclusion of other diagnoses. b. Radiological: Nodular or cavitary opacities on chest radiograph or a chest high-resolution computed tomography (HRCT) scan showing multifocal bronchiectasis with multiple small nodules. c. 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 mycobacterial histopathologic features (granulomatous inflammation or acid-fast bacilli (AFB)) and positive culture for NTM or biopsy showing mycobacterial histopathologic features (granulomatous inflammation or AFB) and one or more sputum or bronchial washes that are culture positive for NTM. Screening samples must be collected within the timeframes stated in the relevant appendix.
- 2. Male or female participants of any age.
- 3. 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 and/or other indications that may have activity against MABS, as specified in FORMaT Prohibited Drug List SOP.
- 4. Informed consent signed by participant or parent/legal guardian if participant is under 18 years of age.
- 5. Ability to comply with study visits, therapies and study procedures as judged by the site investigator.
Exclusion criteria 4
- • 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 FORMaT Prohibited Drug List SOP), except for participants taking azithromycin as part of routine treatment for CF or chronic infection-related pulmonary disease, or as specified in the relevant appendix.
- • 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 to any of the therapies for which no alternative option(s) have been provided.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 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.
- “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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 27
SUB16467MIG · Substance
- Active substance
- Tigecycline
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 8400 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05660MIG · Substance
- Active substance
- Azithromycin
- Pharmaceutical form
- POWDER FOR ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 203000 mg milligram(s)
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05660MIG · Substance
- Active substance
- Azithromycin
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 203000 mg milligram(s)
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05660MIG · Substance
- Active substance
- Azithromycin
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 203000 mg milligram(s)
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07409MIG · Substance
- Active substance
- Cefoxitin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 g gram(s)
- Max total dose
- 1008 g gram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07409MIG · Substance
- Active substance
- Cefoxitin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 g gram(s)
- Max total dose
- 1008 g gram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05431MIG · Substance
- Active substance
- Amikacin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INHALATION
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 406000 mg milligram(s)
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Intravenous form of amikacin delivered via a nebuliser. American Thoracic Society and United States Cystic Fibrosis Foundation/European Cystic Fibrosis Society have published guideline-based therapy for NTM pulmonary disease which includes inhaled amikacin.
SUB07271MIG · Substance
- Active substance
- Ethambutol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 15 mg/Kg milligram(s)/kilogram
- Max total dose
- 6090 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07271MIG · Substance
- Active substance
- Ethambutol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 15 mg/Kg milligram(s)/kilogram
- Max total dose
- 6090 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06694MIG · Substance
- Active substance
- Clofazimine
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 121800 mg milligram(s)
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clofazimine is being used to treat Mycobacterium abscessus pulmonary disease in the FORMaT trial. This is outside of the recommended indications on the summary of product characteristics, Mycobacterium leprae and Hansen's disease.
SUB06694MIG · Substance
- Active substance
- Clofazimine
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 121800 mg milligram(s)
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clofazimine is being used to treat Mycobacterium abscessus pulmonary disease in the FORMaT trial. This is outside of the recommended indications on the summary of product characteristics, Mycobacterium leprae and Hansen's disease.
SUB05431MIG · Substance
- Active substance
- Amikacin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 15 mg/Kg milligram(s)/kilogram
- Max total dose
- 1260 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06641MIG · Substance
- Active substance
- Clarithromycin
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 406000 mg milligram(s)
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06641MIG · Substance
- Active substance
- Clarithromycin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 406000 mg milligram(s)
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06641MIG · Substance
- Active substance
- Clarithromycin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 406000 mg milligram(s)
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06641MIG · Substance
- Active substance
- Clarithromycin
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 406000 mg milligram(s)
- Max treatment duration
- 58 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09086MIG · Substance
- Active substance
- Moxifloxacin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 128800 mg milligram(s)
- Max treatment duration
- 46 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10304MIG · Substance
- Active substance
- Rifabutin
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 450 mg milligram(s)
- Max total dose
- 144900 mg milligram(s)
- Max treatment duration
- 46 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32824 · Substance
- Active substance
- Bedaquiline
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 18800 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08520MIG · Substance
- Active substance
- Linezolid
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 193200 mg milligram(s)
- Max treatment duration
- 46 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10711MIG · Substance
- Active substance
- Sulfamethoxazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1600 mg milligram(s)
- Max total dose
- 515200 mg milligram(s)
- Max treatment duration
- 46 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB11310MIG · Substance
- Active substance
- Trimethoprim
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 103040 mg milligram(s)
- Max treatment duration
- 46 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06264MIG · Substance
- Active substance
- Cilastatin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4 g gram(s)
- Max total dose
- 336 g gram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08151MIG · Substance
- Active substance
- Imipenem
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4 g gram(s)
- Max total dose
- 336 g gram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06393MIG · Substance
- Active substance
- Doxycycline
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 32200 mg milligram(s)
- Max treatment duration
- 46 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06393MIG · Substance
- Active substance
- Doxycycline
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 32200 mg milligram(s)
- Max treatment duration
- 46 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06393MIG · Substance
- Active substance
- Doxycycline
- Pharmaceutical form
- DISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 32200 mg milligram(s)
- Max treatment duration
- 46 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
The University Of Queensland
- Sponsor organisation
- The University Of Queensland
- Address
- Cumbrae Stewart Building 72, Research Road Research Road
- City
- Brisbane
- Postcode
- 4072
- Country
- Australia
Scientific contact point
- Organisation
- The University Of Queensland
- Contact name
- FORMaT Trial Management Team
Public contact point
- Organisation
- The University Of Queensland
- Contact name
- FORMaT Trial Management Team
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 20 | 1 |
| Rest of world
United Kingdom, Taiwan, Israel, Singapore, New Zealand, Australia, Canada
|
— | 280 | — |
Investigational sites
Rigshospitalet
Rigshospitalet Blemdamsvej 9, Blegdamsvej 9, 2100, Copenhagen Oe
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-01-02 | 2023-06-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 38 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_FORMaT Master Protocol with appendices_2023-506575-99 | 4.1 |
| Protocol (for publication) | DK-MARS_5-Danish-Version-Template-2018 | 1 |
| Protocol (for publication) | Dnk-Effective-Denmark-EQ-5D-5L-Paper-Self-Complete-ID-24787_A23Oct2019_v1-0 | 1 |
| Protocol (for publication) | FORMaT-CT-RadiologistQuestionnaire-V1-0_22Apr2024-cleanrevised | 1 |
| Protocol (for publication) | FORMaT-CT-TechQuestionnaire-V1-0_22Apr2024-cleanrevised | 1 |
| Recruitment arrangements (for publication) | K1_Danish Supplement To The Master Protocol_2023-506575-99 | 1.5 |
| Recruitment arrangements (for publication) | K1_Danish Supplement to The Master Protocol_Tracked changes_2023-506575-99 | 1.5 |
| Subject information and informed consent form (for publication) | L1_ FORMaT Master Protocol POA in Danish_2023-506575-99 | 1.2 |
| Subject information and informed consent form (for publication) | L1_FORMaT Intervention Program PCF in Danish_2023-506575-99 | 1.2 |
| Subject information and informed consent form (for publication) | L1_FORMaT Intervention Program PIS Danish_REDACTED_2023-506575-99 | 1.4 |
| Subject information and informed consent form (for publication) | L1_FORMaT Intervention Program WC in Danish_2023-506575-99 | 1.2 |
| Subject information and informed consent form (for publication) | L1_FORMaT Master Protocol PCF in Danish_2023-506575-99 | 1.4 |
| Subject information and informed consent form (for publication) | L1_FORMaT Master Protocol PIS_Danish_REDACTED_2023-506575-99 | 1.4 |
| Subject information and informed consent form (for publication) | L1_FORMaT Master Protocol WC in Danish_2023-506575-99 | 1.2 |
| Subject information and informed consent form (for publication) | L1_FORMaT Observational Cohort PCF_2023-506575-99 | 1 |
| Subject information and informed consent form (for publication) | L1_FORMaT Observational Cohort PIS_REDEACTED_2023-506575-99 | 1.1 |
| Subject information and informed consent form (for publication) | L1_FORMaT Observational Cohort WC_2023-506575-99 | 1 |
| Subject information and informed consent form (for publication) | L1_FORMaT Pregnancy PCF_2023-506575-99 | 1 |
| Subject information and informed consent form (for publication) | L1_FORMaT Pregnancy PIS_2023-506575-99 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | AmicacinMacure-Common-UK | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | AmicacinMacure-Common-UK | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Avelox-400Mg-Film-coated-Tablets-SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Azithromycin500mgFCTsandoz | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Cefoxitin-1g-and-2g-SPMC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | DoxycyclineCapsules-BP-100mg-SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ethambutol400-Mg-Tablets-SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | ImipenemcilastatinEnglish-SPC-Common-Eng | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | LAMPRENE-clofazimine-IPL-E | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | MycobutinSummary-Of-Product-Characteristics | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Sirturo-epar-product-Information-En | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Trimethoprim-sulfamethoxazole40mg800mgTabs | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Tygacilepar-product-Information-En | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Uk-Accord-clarithromcyin-250mg-FCT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Zyvox 600 Mg Film Coated Tablets Summary Of Product Characteristics EMC | 1 |
| Synopsis of the protocol (for publication) | D1_FORMaT Protocol Summary Danish_Tracked changes_2023-506575-99 | 1.5 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary English_2023-506575-99 | 1.5 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary English_Tracked changes_2023-506575-99 | 1.5 |
| Synopsis of the protocol (for publication) | D1_Protocol-Summary Danish_2023-506575-99 | 1.5 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-27 | Denmark | Acceptable 2023-07-20
|
2023-07-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-19 | Denmark | Acceptable 2024-05-17
|
2024-05-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-23 | Denmark | Acceptable 2025-02-21
|
2025-02-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-16 | Denmark | Acceptable 2025-10-10
|
2025-10-13 |