Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium T… (NCT05534750) | Clinical Trial Compass
RecruitingPhase 2
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)
France60 participantsStarted 2023-04-20
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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 the anti-tuberculosis drugs used detected by a genotypic test in accordance with the recommendations of the High Council of Public Health of 2015;
* History of anti-tuberculosis treatment (patients with a documented negative genotypic test for isoniazid and rifampicin resistance may be included)
* History of treatment in the previous two years with one of the antibiotics evaluated in this trial lasting more than one month;
* Absolute contraindication to the use of at least one of the test mol…
What they're measuring
1
Assessment of the early bactericidal activity (EBA) of tedizolid (200mg / day) at the end of the first 2 days of treatment (D3).