Actively Recruiting
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-02-03
60
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and less than 75 years old
- Women of childbearing potential must use effective contraception during the study and up to 6 months after treatment; mechanical contraception (condom) is strongly recommended
- Men must use effective contraception during the study and up to 3 months after treatment
- First pulmonary infection with Mycobacterium tuberculosis suspected by symptoms, chest X-ray or CT, and positive sputum test, confirmed by genotypic test showing no resistance to rifampicin
- No clinical signs of extra-thoracic involvement
- Applicants processing state medical assistance if not covered by social security
- Signed informed consent
You will not qualify if you...
- Resistance to any anti-tuberculosis drug used in the study as detected by genotypic test
- History of anti-tuberculosis treatment (unless documented negative resistance tests for isoniazid and rifampicin)
- Treatment in the past two years with one of the antibiotics studied lasting more than one month
- Absolute contraindication to any study drug (isoniazid, rifampicin, ethambutol, pyrazinamide, linezolid, tedizolid)
- Severe tuberculosis requiring immediate standard treatment (oxygen need, severe immunosuppression, extra-pulmonary involvement, intensive care requirement)
- HIV patients on protease inhibitors that cannot be changed and contraindicated with study drugs
- Active cancer receiving chemotherapy or radiotherapy
- Decompensated liver cirrhosis
- Pregnancy, breastfeeding, or desire to become pregnant during study and required contraception period
- Adults under guardianship or legal protection
- Significant lab abnormalities including low hemoglobin, low neutrophils, low platelets, low kidney function, or high liver enzymes
- Hyperuricaemia or porphyria
- Optic neuritis or peripheral neuropathy
- Body mass index 16 kg/m2 or lower
- Participation in other interventional research
- Current treatment with medications contraindicated with linezolid or standard therapy such as monoamine oxidase inhibitors or specific antiviral and antifungal drugs
- Use of gastrointestinal topicals, antacids, adsorbents, or aluminum salts incompatible with study drugs
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Trial Site Locations
Total: 1 location
1
Bacteriology department- Hôpital Saint-Antoine
Paris, France, 75012
Actively Recruiting
Research Team
N
Nicolas VEZIRIS, PU-PH
CONTACT
R
Ruxandra CALIN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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