NCT05534750 Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)
| NCT ID | NCT05534750 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-04-20 |
| Primary Completion | 2026-04 |
Trial Parameters
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Brief Summary
The objective of this work is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid (reference molecule for the treatment of multidrug-resistant tuberculosis) and with that of standard quadruple therapy (reference treatment of drug susceptible tuberculosis).
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old and \<75 years old * Woman on childbearing age should be on effective contraception during the duration of the study and up to 6 months after treatment; a mechanical contraception (use of condom) will be strongly recommended * Male (effective contraception must be used during duration of the study and up to 3 months after treatment) * Patient with a first infection with Mycobacterium tuberculosis of pulmonary localization suspected by the presence of a clinical pulmonary symptomatology, a chest X-ray or an abnormal chest computed tomography, and the positive microscopic examination of a sputum (AFB +, presence of AFB) with confirmation of tuberculosis by a genotypic test demonstrating no resistance to rifampicin, without clinical signs of extra-thoracic involvement * State medical assistance application being processed ( If patient does not benefit from social security), * Signature of informed consent Exclusion Criteria: * Resistance to one of