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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Region Oestergoetland	Linkoping	Sweden
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland	Norrkoping	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not yet recruiting	23.11.2020

Trial locations

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.

Investigated diseases:

Tuberculosis

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 ID:

2024-518772-32-00

Protocol code:

HIGH-SHORT RP

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?