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Study on Higher Doses of Rifampicin and Pyrazinamide for Shortened Treatment of Mild-to-Moderate Tuberculosis in Patients with Drug-Sensitive Pulmonary TB

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 tuberculosis, a disease that primarily affects the lungs and is caused by bacteria. The study is investigating the use of higher doses of two antibiotics, rifampicin and pyrazinamide, to see if they can effectively shorten the treatment duration for patients with mild-to-moderate tuberculosis. These medications are taken orally, meaning they are swallowed in pill form.

The purpose of the study is to explore whether a shorter treatment period with higher doses of these medications can be safe and effective for patients with drug-sensitive pulmonary tuberculosis. Participants in the study will receive either the higher doses of the medications or the standard treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects.

Throughout the study, participants will be monitored to assess how their bodies process the medications and to ensure their safety. The study will last for a period of up to four months, during which time participants will have regular check-ups and tests to track their progress and any side effects. The goal is to find a more efficient way to treat tuberculosis, potentially reducing the time patients need to be on medication.

The research process

The trial runs in 5 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, you will be required to provide written consent, confirming your willingness to participate.

    You must have confirmed active pulmonary tuberculosis, which means a positive culture or PCR test for M.tuberculosis-complex.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the criteria for the study. This includes confirming that you have not yet started tuberculosis treatment.

  3. Step 3

    Medication administration

    You will receive higher doses of two medications: rifampicin and pyrazinamide. These medications are taken orally.

    The study aims to explore the effects of these higher doses in a shorter treatment period for mild-to-moderate tuberculosis.

  4. Step 4

    Monitoring and follow-up

    Your response to the medication will be closely monitored. This includes measuring the concentration of the medication in your body on day 1 after the first dose and again at week 2.

    Regular follow-up visits will be scheduled to ensure your safety and to assess the effectiveness of the treatment.

  5. Step 5

    Completion of the study

    The study is expected to continue until December 31, 2028. Your participation will contribute to understanding the potential for shorter tuberculosis treatments.

Who can join the trial?

5 criteria

  • Must have confirmed active pulmonary tuberculosis, which means a positive test result for the bacteria that cause tuberculosis in the lungs.
  • Must have provided written consent, which means you agree to participate in the study and have signed a form to confirm this.
  • Must be assigned for TB-treatment with first-line drugs but have not yet started the treatment.
  • Both male and female participants are eligible.
  • Participants should be within the specified age range for the study.

Who cannot join the trial?

3 criteria

  • Patients who do not have **drug-sensitive pulmonary tuberculosis**. This means the type of tuberculosis that can be treated with standard medications.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means groups that might need special protection or care.
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Investigated drugs

  • Rifampicin

    is a medication used to treat tuberculosis (TB). It works by killing the bacteria that cause TB, helping to clear the infection from the body. In this clinical trial, researchers are studying how higher doses of rifampicin might shorten the treatment time for people with mild-to-moderate TB.

  • Pyrazinamide

    is another medication used in the treatment of tuberculosis. It helps to kill the bacteria that cause the disease, especially in the early stages of treatment. This trial is exploring whether using higher doses of pyrazinamide, along with rifampicin, can effectively reduce the length of TB treatment for patients with drug-sensitive pulmonary TB.

What is already known about the treatment

  • Rifampicin

    Rifampicin is a medication administered orally, typically in the form of a tablet or capsule. It is currently being studied in clinical trials to explore its effectiveness in treating tuberculosis (TB) with higher doses over a shorter period. The main therapeutic use of Rifampicin is to treat tuberculosis, a serious lung infection. At the molecular level, Rifampicin works by inhibiting the bacterial RNA polymerase enzyme, which is essential for the bacteria to make proteins and reproduce. It is classified as an antibiotic, specifically a rifamycin derivative.

  • Pyrazinamide

    Pyrazinamide is taken orally, usually as a tablet, and is being evaluated in clinical trials for its potential to shorten the treatment duration for tuberculosis when used in higher doses. Its primary use is to treat tuberculosis, particularly in combination with other TB medications. Pyrazinamide's mechanism of action involves disrupting the energy production in the bacteria that cause TB, making it difficult for them to survive. It is classified as an anti-tubercular agent.

Investigated diseases

Tuberculosis – Tuberculosis is an infectious disease caused by the bacterium Mycobacterium tuberculosis. It primarily affects the lungs, leading to pulmonary tuberculosis, but can also impact other parts of the body. The disease progresses slowly, with symptoms that may include a persistent cough, chest pain, and coughing up blood. As the infection advances, individuals may experience weight loss, fever, night sweats, and fatigue. Tuberculosis spreads through the air when an infected person coughs or sneezes, making it highly contagious. The progression of the disease can vary, with some individuals remaining asymptomatic for long periods, while others may develop active symptoms more rapidly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518772-32-00Protocol codeHIGH-SHORT RPEstimated enrolment40 patientsSponsorRegion Oestergoetland

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