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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Hopitaux Universitaires Pitie Salpetriere Paris France
Hopital Tenon Paris France
Hopital Beaujon Clichy France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
20.04.2023

Trial locations

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.

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 ID:
2024-512759-19-00
Protocol code:
APHP210084
NCT ID:
NCT05534750
Trial Phase:
Therapeutic exploratory (Phase II)

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