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Study on the Effectiveness and Safety of High-Dose Rifampicin, Moxifloxacin, and Linezolid for Patients with Pulmonary 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 treatment of pulmonary tuberculosis, a serious lung infection caused by bacteria. The study will evaluate the effectiveness and safety of a combination of medications, including high doses of rifampicin, moxifloxacin, and linezolid. These medications are known for their ability to fight bacterial infections, with rifampicin and moxifloxacin being antibiotics, and linezolid also serving as an antibiotic. The trial aims to compare this new treatment approach to the standard treatment currently used for patients with this type of tuberculosis.

Participants in the study will receive either the new combination of drugs or the standard treatment. The study will last for a period of eight weeks, during which the health and progress of the participants will be closely monitored. The goal is to determine if the new treatment can more effectively clear the infection from the lungs and improve patient outcomes compared to the standard treatment. The study will also assess the safety of the new treatment by monitoring any side effects that participants may experience.

Throughout the trial, researchers will collect data on how well the treatment works in reducing the presence of bacteria in the lungs and how well participants tolerate the medications. This information will help in understanding the potential benefits and risks of using high-dose rifampicin, moxifloxacin, and linezolid for treating pulmonary tuberculosis. The findings from this study could lead to improved treatment options for patients suffering from this serious lung infection.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of smear-positive pulmonary tuberculosis, and obtaining consent.

    Women of childbearing age undergo a pregnancy test to ensure eligibility.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of a combination of anti-tuberculous drugs.

    The regimen includes high-dose rifampicin, high-dose moxifloxacin, and linezolid.

  3. Step 3

    Medication schedule

    The medications are taken orally in the form of film-coated tablets or hard capsules.

    The treatment duration is 8 weeks, with daily administration as per the study protocol.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring is conducted to evaluate the efficacy and safety of the treatment.

    The primary goal is to achieve sterilization of sputum culture in liquid medium by the end of 8 weeks.

  5. Step 5

    Safety assessment

    Safety is assessed by monitoring for any adverse events, particularly those of grade 3 or higher.

    The tolerability of the treatment is evaluated throughout the study period.

  6. Step 6

    Final evaluation

    At the end of the 8-week treatment period, a final evaluation is conducted.

    This includes assessing the overall efficacy, safety, and quality of life of the patient.

Who can join the trial?

4 criteria

  • Must be older than 18 years.
  • Must have a diagnosis of smear-positive pulmonary tuberculosis. This means that a test has shown the presence of tuberculosis bacteria in the lungs.
  • Must sign a consent form, which is a document that shows you agree to participate in the study after understanding what it involves.
  • Women who can have children must have a negative pregnancy test. This applies to women who have started menstruating and have not yet gone through menopause, unless they are infertile. Infertility can be due to certain surgeries like removal of the uterus (hysterectomy), removal of both fallopian tubes (double salpingectomy), or removal of both ovaries (double oophorectomy).

Who cannot join the trial?

3 criteria

  • Patients who do not have smear-positive pulmonary tuberculosis. This means the bacteria causing tuberculosis can be seen in a sample of mucus from the lungs under a microscope.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Rifampicin

    is a medication used to treat tuberculosis. In this trial, it is given in a higher dose than usual to see if it can be more effective in treating pulmonary tuberculosis.

  • Moxifloxacin

    is an antibiotic that helps fight bacteria in the body. In this study, it is used in a higher dose to determine if it can improve the treatment of tuberculosis when combined with other drugs.

  • Linezolid

    is an antibiotic that is used to treat certain serious bacterial infections. In this trial, it is part of a combination of drugs being tested for its effectiveness and safety in treating pulmonary tuberculosis.

What is already known about the treatment

  • Rifampicin

    Rifampicin is administered orally in the form of tablets or capsules. It is currently used in the treatment of tuberculosis and is well-documented in medical literature. The main therapeutic indication is for the treatment of active tuberculosis, particularly pulmonary tuberculosis. At the molecular level, rifampicin works by inhibiting bacterial RNA synthesis, effectively stopping the bacteria from multiplying. It is classified as an antibiotic, specifically a rifamycin derivative.

  • Moxifloxacin

    Moxifloxacin is typically administered orally as tablets or intravenously. It is recognized in medical literature for its use in treating various bacterial infections, including tuberculosis. The primary therapeutic indication is for the treatment of respiratory tract infections, including pulmonary tuberculosis. Moxifloxacin acts by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes crucial for bacterial DNA replication. It belongs to the pharmacological class of fluoroquinolone antibiotics.

  • Linezolid

    Linezolid is administered orally in tablet form or intravenously. It is well-established in medical literature for treating infections caused by Gram-positive bacteria, including tuberculosis. The main therapeutic indication is for treating drug-resistant tuberculosis. Linezolid works by inhibiting bacterial protein synthesis, which prevents the bacteria from growing and reproducing. It is classified as an oxazolidinone antibiotic.

Investigated diseases

Pulmonary Tuberculosis – Pulmonary tuberculosis is a contagious bacterial infection that primarily affects the lungs. It is caused by the bacterium Mycobacterium tuberculosis, which spreads through the air when an infected person coughs or sneezes. The disease begins with symptoms such as a persistent cough, chest pain, and coughing up blood or sputum. As it progresses, individuals may experience fatigue, weight loss, fever, and night sweats. The infection can remain dormant in the body for years before becoming active. If untreated, it can lead to significant lung damage and other complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509075-17-00Protocol codeRML-TBEstimated enrolment120 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

sourced from the EU Clinical Trials Register and site verification

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