Region Oestergoetland
Linkoping, Sweden
Rare diseases
Investigational molecules
Locations
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 trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
5 criteria
3 criteria
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Linkoping, Sweden
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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.
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.
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 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.
sourced from the EU Clinical Trials Register and site verification
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