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Study on the Effects of Tedizolid and Linezolid for Patients with Suspected Lung Tuberculosis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of certain medications on a lung infection caused by Mycobacterium tuberculosis, commonly known as tuberculosis. The study will evaluate the early effects of two medications, tedizolid and linezolid, on this infection. Additionally, the study will compare these medications to a standard treatment that includes rifampicin, isoniazid, pyrazinamide, and ethambutol. These medications are taken orally, meaning they are swallowed in pill form.

The purpose of the study is to assess how well these medications work in reducing the bacteria in the lungs during the early days of treatment. Participants will take the medications for a period of up to seven days. The study will involve taking samples from the lungs to measure the number of bacteria present at different times during the treatment. This will help determine how quickly the medications are working to reduce the infection.

Throughout the study, the safety and any side effects of the medications will be monitored. The study aims to provide valuable information on the effectiveness of tedizolid and linezolid compared to the standard treatment for tuberculosis. This research could help improve treatment options for people with this lung infection in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age and health status.

    Informed consent is signed to acknowledge understanding of the study's procedures and objectives.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the presence of a lung infection caused by Mycobacterium tuberculosis.

    This includes a clinical examination, chest X-ray, or CT scan, and a sputum test to confirm tuberculosis.

  3. Step 3

    Treatment initiation

    Treatment begins with the administration of tedizolid at a dose of 200 mg per day.

    The treatment is taken orally for the first two days.

  4. Step 4

    Early bactericidal activity assessment

    The early bactericidal activity (EBA) of tedizolid is assessed at the end of the first two days.

    This involves measuring the reduction in the number of bacteria in the sputum.

  5. Step 5

    Comparison of treatments

    The effectiveness of tedizolid is compared to linezolid (1200 mg per day) and a standard quadruple therapy.

    This comparison is made between Day 1 and Day 3, and between Day 3 and Day 8.

  6. Step 6

    Further bactericidal activity assessment

    Further assessment of bactericidal activity is conducted between Day 3 and Day 8.

    This includes measuring the time it takes for cultures to show bacterial growth.

  7. Step 7

    Monitoring and evaluation

    The concentration of tedizolid in the body is measured at various intervals to assess its presence and effectiveness.

    Toxicity and any adverse effects are evaluated on Day 7 and Day 30.

Who can join the trial?

6 criteria

  • Must be between 18 and 74 years old.
  • If a woman is of childbearing age, she should use effective birth control during the study and for 6 months after treatment. Using a condom is strongly recommended.
  • If a man, effective birth control must be used during the study and for 3 months after treatment.
  • Must have a first suspected infection with Mycobacterium tuberculosis in the lungs. This means showing symptoms related to the lungs, having an unusual chest X-ray or CT scan, and a positive test from a sputum sample. The test should confirm tuberculosis without resistance to a medicine called rifampicin, and there should be no signs of the disease outside the chest area.
  • If the patient does not have social security, their application for state medical assistance should be in process.
  • Must sign an informed consent form, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

3 criteria

  • Patients who have had a previous infection with Mycobacterium tuberculosis in the lungs. This is a type of bacteria that can cause lung disease.
  • Patients who are not within the age range specified for the study. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care.
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Investigated drugs

  • Tedizolid

    is an antibiotic being studied for its ability to kill bacteria, specifically Mycobacterium tuberculosis, which causes tuberculosis. The trial is evaluating how effective tedizolid is in reducing the number of bacteria in the body during the first few days of treatment.

  • Linezolid

    is another antibiotic included in the study. It is also used to treat infections caused by bacteria, including Mycobacterium tuberculosis. The trial is comparing the effectiveness of linezolid to tedizolid in reducing the bacterial load in patients with tuberculosis.

What is already known about the treatment

  • Tedizolid

    Tedizolid is administered orally in tablet form, typically at a dose of 200 mg per day. It is currently being studied for its effectiveness against lung infections caused by Mycobacterium tuberculosis. The main therapeutic indication is its potential use in treating tuberculosis. At the molecular level, tedizolid works by inhibiting bacterial protein synthesis, which is essential for bacterial growth and replication. It belongs to the pharmacological class of oxazolidinone antibiotics.

  • Linezolid

    Linezolid is available in both oral and intravenous forms, allowing for flexible administration depending on the patient's needs. It is being evaluated for its ability to combat Mycobacterium tuberculosis infections in the lungs. The primary therapeutic use of linezolid is in treating various bacterial infections, including those resistant to other antibiotics. Its mechanism of action involves blocking bacterial protein synthesis, thereby preventing the bacteria from multiplying. Linezolid is also classified as an oxazolidinone antibiotic.

Investigated diseases

Tuberculosis – Tuberculosis is a bacterial infection caused by Mycobacterium tuberculosis, primarily affecting the lungs. It spreads through the air when an infected person coughs or sneezes. The disease begins with the bacteria entering the lungs, where they can remain dormant or become active. In its active form, tuberculosis can cause symptoms such as a persistent cough, chest pain, and coughing up blood. As the infection progresses, it can lead to weight loss, fatigue, and fever. If not contained, the bacteria can spread to other parts of the body, causing further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512759-19-00Protocol codeAPHP210084Estimated enrolment60 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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