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Evaluation of the early bactericidal activity of tedizolid and linezolide against Mycobacterium tuberculosis (TEDITUB)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512759-19-00
Acronym
APHP210084
Enrollment
60
Registered
2024-08-13
Start date
2023-04-20
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

first suspected infection with Mycobacterium tuberculosis in the lungs

Brief summary

The measurement will be done as follow: EABD1D3= (log10 number of CFU (CFU= colony forming unit) of M. tuberculosis on medium 7H11/mL of sputum on D1) - (log10number of CFU of M. tuberculosis on medium 7H11/mL of sputum on D3)/2.

Detailed description

The measurement will be done as follow: EBAD3D8= (log10 number of CFU (CFU=colony forming unit) of M. tuberculosis on medium 7H11/mL of sputum on D3) - ( log10 number of CFU of M. tuberculosis on medium 7H11/mL of sputum at D8)/5, Compare the early bactericidal activity of tedizolid 200 mg / day to that of linezolid 1200 mg / day between Day 1 and Day 3 and between Day 3 and Day 8, Compare the early bactericidal activity of tedizolid 200 mg / day to that of standard quadruple therapy between Day 1 and Day 3 and between Day 3 and Day 8, ABPJ1J3 of tedizolide measured in terms of time to positivity of cultures in liquid medium called ABPJ1J3L= (time to positivity of culture of sample at D3) - (time to positivity of culture of sample at D1)/2 (i.e. after the first 2 days of treatment with tedizolide), Bactericidal activity in liquid medium between D3 and D8 (ABPJ3J8L) of tédizolide, ABPJ1J3L and ABPJ3J8L of tedizolide compared with linezolide, ABPJ1J3L and ABPJ3J8L of tedizolide compared with standard four-therapy treatment, Total and free concentration of tedizolid measured at 0, 1, 3, 5, and 24h, Area under the curve (AUC), Toxicity of tedizolide assessed at D7 and D30. Adverse events leading to premature discontinuation of treatment

Interventions

DRUGLINEZOLID
DRUGPYRAZINAMIDE
DRUGISONIAZID
DRUGETHAMBUTOL
DRUGRIFAMPICIN
DRUGPYRAZINAMIDE AND ISONIAZID

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The measurement will be done as follow: EABD1D3= (log10 number of CFU (CFU= colony forming unit) of M. tuberculosis on medium 7H11/mL of sputum on D1) - (log10number of CFU of M. tuberculosis on medium 7H11/mL of sputum on D3)/2.

Secondary

MeasureTime frame
The measurement will be done as follow: EBAD3D8= (log10 number of CFU (CFU=colony forming unit) of M. tuberculosis on medium 7H11/mL of sputum on D3) - ( log10 number of CFU of M. tuberculosis on medium 7H11/mL of sputum at D8)/5, Compare the early bactericidal activity of tedizolid 200 mg / day to that of linezolid 1200 mg / day between Day 1 and Day 3 and between Day 3 and Day 8, Compare the early bactericidal activity of tedizolid 200 mg / day to that of standard quadruple therapy between Day 1 and Day 3 and between Day 3 and Day 8, ABPJ1J3 of tedizolide measured in terms of time to positivity of cultures in liquid medium called ABPJ1J3L= (time to positivity of culture of sample at D3) - (time to positivity of culture of sample at D1)/2 (i.e. after the first 2 days of treatment with tedizolide), Bactericidal activity in liquid medium between D3 and D8 (ABPJ3J8L) of tédizolide, ABPJ1J3L and ABPJ3J8L of tedizolide compared with linezolide, ABPJ1J3L and ABPJ3J8L of tedizolide compared

Countries

France

Outcome results

None listed

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