Tedizolid vs Linezolid for Multidrug Resistant Tuberculosis

Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)

Recruiting Phase 2 Interventional Study
Tuberculosis Multidrug Resistant Tuberculosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
Who this trial is looking for

This trial is looking for adults with pulmonary tuberculosis who have not received certain treatments recently. Participants will take either tedizolid or linezolid and have their progress monitored.

Are You a Good Fit for This Trial?
Must not be taking Monoamine oxidase inhibitorsRitonavir-boosted protease inhibitorsCertain antiviral drugs
Rules you out PregnancySevere immunosuppressionActive cancerHIV with protease inhibitors

You may be able to join if

  • I am between 18 and 75 years old.
  • I have a first infection with Mycobacterium tuberculosis confirmed by tests.
  • I have no signs of extra-thoracic involvement.
  • I can sign informed consent.
  • I'm applying for medical assistance if I don’t have social security.
  • If I am a woman of childbearing age, I will use effective contraception.
  • If I am a man, I will use effective contraception.

You may not be able to join if

  • I have resistance to anti-tuberculosis drugs.
  • I have received anti-tuberculosis treatment before.
  • I have been treated with certain antibiotics for more than a month in the past two years.
  • I have serious health issues that require immediate treatment.
  • I am pregnant, planning to become pregnant, or breastfeeding.
  • I have significant laboratory abnormalities.
  • I have certain serious medical conditions like decompensated cirrhosis.
  • I am taking medications that cannot be combined with the study drugs.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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).

Trial Locations
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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 m…
Contacts

Nicolas VEZIRIS, PU-PH

01 49 28 30 41

nicolas.veziris@aphp.fr

CONTACT

Ruxandra CALIN, MD

01 56 01 74 12

ruxandra.calin@aphp.fr

CONTACT