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Finding the Optimal Regimen for Mycobacterium abscessus Treatment

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506575-99-00
Acronym
FORMaT001
Enrollment
20
Registered
2023-07-21
Start date
2023-01-02
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycobacterium abscessus pulmonary disease

Brief summary

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.

Interventions

DRUGLINEZOLID
DRUGDOXYCYCLINE
DRUGCLARITHROMYCIN
DRUGMOXIFLOXACIN
DRUGAMIKACIN
DRUGIMIPENEM
DRUGCLOFAZIMINE
DRUGRIFABUTIN
DRUGAZITHROMYCIN
DRUGTIGECYCLINE
DRUGETHAMBUTOL
DRUGBEDAQUILINE

Sponsors

The University Of Queensland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026