Ongoing Clinical Trials for Tuberculosis
There are currently 4 clinical trials studying new ways to treat tuberculosis, focusing on optimizing antibiotic doses and shortening treatment duration. These trials are being conducted across several European countries including France, Denmark, Italy, the Netherlands, Spain, and Sweden, and are investigating medications such as tedizolid, linezolid, rifampicin, and pyrazinamide for patients with drug-sensitive tuberculosis.
Clinical trial locations
- Denmark
- France
- Italy
- Netherlands
- Spain
- Sweden
Study on the Effects of Tedizolid and Linezolid for Patients with Suspected Lung Tuberculosis
This trial is taking place in France and is evaluating two antibiotics, tedizolid and linezolid, as potential treatments for lung infections caused by Mycobacterium tuberculosis. The study aims to assess how quickly these medications can reduce the amount of bacteria in the lungs during the early days of treatment, and compare their effectiveness to standard therapy that includes rifampicin, isoniazid, pyrazinamide, and ethambutol.
Main inclusion criteria:
- Age between 18 and 74 years
- First suspected lung infection with Mycobacterium tuberculosis, confirmed through chest X-ray or CT scan and positive sputum test showing no resistance to rifampicin
- Women of childbearing age must use effective birth control during the study and for 6 months after treatment
- Men must use effective birth control during the study and for 3 months after treatment
- Willingness to sign an informed consent form
Main exclusion criteria:
- Previous lung infection with Mycobacterium tuberculosis
- Not within the specified age range
- Part of a vulnerable population requiring special protection or care
Focus of the trial: The study measures how effectively tedizolid and linezolid reduce bacterial levels in the lungs over a treatment period of up to seven days. Researchers collect lung samples at different times to track the reduction in bacteria and monitor any side effects. The trial specifically evaluates tedizolid at 200 mg per day and linezolid at 1200 mg per day, comparing their early bactericidal activity between Day 1 and Day 3, and between Day 3 and Day 8.
Investigational drugs: Tedizolid is an antibiotic from the oxazolidinone class that works by blocking bacterial protein synthesis, preventing bacteria from growing and multiplying. It is administered orally at 200 mg per day. Linezolid is another oxazolidinone antibiotic with a similar mechanism of action, available in both oral and intravenous forms and being evaluated at higher doses for its effectiveness against Mycobacterium tuberculosis.
Study on the Safety and Tolerability of Higher Dose Rifampicin for Tuberculosis Patients
This trial is being conducted in Denmark, Italy, and the Netherlands. It focuses on evaluating whether a higher dose of rifampicin, a commonly used antibiotic for treating the disease, can be safely used over a six-month period. The main concern is monitoring for liver-related side effects, known as hepatotoxicity.
Main inclusion criteria:
- Age 18 years or older
- Diagnosis of lung-based disease according to local diagnostic criteria
- No known allergic reactions or past toxic reactions to rifampicin
- For women of childbearing potential: negative blood pregnancy test and agreement to use effective birth control during the study, and not breastfeeding
- Ability to follow the study schedule
- Provided informed consent
Main exclusion criteria:
- Current or past diagnosis of the disease being studied
- Previous experience of liver damage from medications
- Not within the specified age range
- Part of a vulnerable population unable to give consent
Focus of the trial: The study monitors participants over six months to observe any occurrence of hepatotoxicity and other side effects from the optimized higher dose of rifampicin. Regular check-ups include blood tests to assess liver function, and evaluations at two and three months check for culture conversion, which indicates the medication’s effectiveness. The final assessment determines treatment outcomes based on World Health Organization definitions of cure.
Investigational drug: Rifampicin is an antibiotic from the rifamycin class that works by inhibiting bacterial RNA polymerase, an enzyme crucial for bacteria to reproduce and survive. In this trial, researchers are testing whether an increased dose is safe and well-tolerated, particularly focusing on the risk of liver damage over the treatment period.
Study on High-Dose Rifampicin Safety for Adults with Complex Tuberculosis Using Isoniazid, Pyrazinamide, and Ethambutol Combination
This trial is taking place in the Netherlands and Spain and is studying the safety of high-dose rifampicin for adults with difficult-to-treat forms of the disease, including cases affecting the lungs and other parts of the body. The study uses rifampicin in combination with isoniazid, pyrazinamide, and ethambutol.
Main inclusion criteria:
- Confirmed or probable disease affecting the lungs or other parts of the body, with drug-sensitive bacteria
- Positive test results such as positive smear, positive Xpert MTB/RIF test, or positive culture for confirmed cases; or tissue examination showing specific damage or fluid tests suggesting the disease for probable cases
- Female participants of childbearing potential must have a negative pregnancy test
- Age 60 years or older, OR age 18 years or older with at least one of the following: low body mass index (18.5 or less), HIV infection, diabetes, hepatitis C or B infection, daily alcohol intake of 2 or more units, chronic liver disease, or involvement of the brain or spinal cord
- Provided informed consent
Main exclusion criteria:
- Under 18 years of age
- Not diagnosed with the disease being studied
- Not part of the difficult-to-treat subgroups
- Part of a vulnerable population at higher risk of harm or exploitation
Focus of the trial: The study evaluates the safety of rifampicin at 35 mg per kilogram of body weight per day, combined with standard doses of isoniazid, pyrazinamide, and ethambutol, over an 8-week period. Researchers monitor participants for severe adverse events and assess the treatment’s effectiveness, including how quickly sputum cultures convert from positive to negative. The trial also evaluates quality of life changes and treatment costs.
Investigational drugs: Rifampicin is being tested at a higher dose than usual to determine if it is safe for patients with complex cases. Isoniazid, pyrazinamide, and ethambutol are standard antibiotics used in combination treatment. Isoniazid and ethambutol work by killing the bacteria, while pyrazinamide helps kill bacteria particularly in the early stages of treatment. All medications are administered orally.
Study on Higher Doses of Rifampicin and Pyrazinamide for Shortened Treatment of Mild-to-Moderate Tuberculosis in Patients with Drug-Sensitive Pulmonary TB
This trial is being conducted in Sweden and investigates whether higher doses of rifampicin and pyrazinamide can effectively shorten the treatment duration for patients with mild-to-moderate lung disease caused by drug-sensitive bacteria. The study aims to find a more efficient treatment approach that reduces the time patients need to take medication.
Main inclusion criteria:
- Confirmed active lung disease with a positive culture or PCR test for the bacteria
- Provided written consent to participate
- Assigned for treatment with first-line drugs but have not yet started
- Both male and female participants eligible
- Within the specified age range for the study
Main exclusion criteria:
- Do not have drug-sensitive lung disease
- Not within the specified age range
- Part of a vulnerable population requiring special protection or care
Focus of the trial: The study explores whether higher doses of rifampicin and pyrazinamide can safely and effectively treat mild-to-moderate cases over a shorter period, potentially up to four months. Participants undergo regular monitoring to track their progress and ensure safety. The concentration of medications in the body is measured on day 1 after the first dose and again at week 2 to assess how the body processes these higher doses.
Investigational drugs: Rifampicin works by inhibiting bacterial RNA polymerase, preventing the bacteria from making proteins and reproducing. Pyrazinamide disrupts energy production in the bacteria, making it difficult for them to survive. Both medications are taken orally, and the trial is studying whether higher doses of these antibiotics can reduce the overall treatment time for patients with drug-sensitive cases.
Summary
These four clinical trials represent important research efforts to improve treatment for people with drug-sensitive forms of the disease. A notable pattern is the concentration of trials in the Netherlands, which is participating in two studies, while other European countries including France, Denmark, Italy, Spain, and Sweden each host one trial.
The primary focus across most trials is on optimizing the use of rifampicin, with three of the four studies investigating higher doses of this antibiotic. Researchers are particularly interested in understanding whether increased doses can either shorten treatment duration or improve outcomes for patients who are difficult to treat due to age or other health conditions. Safety monitoring, especially for liver-related side effects, is a key component of these studies.
One trial takes a different approach by evaluating tedizolid and linezolid, two oxazolidinone antibiotics, as alternatives or complements to standard treatment. This diversification of research approaches reflects the medical community’s ongoing efforts to find more effective and efficient treatment options.
All trials focus exclusively on drug-sensitive cases, meaning the bacteria can still be treated with standard medications. Participants in these studies will benefit from close monitoring and may contribute to improving treatment protocols that could help many patients in the future. Anyone interested in participating should discuss the specific eligibility requirements with their healthcare provider, as criteria vary between studies based on age, disease severity, and other health factors.
