Study of cysteamine combined with standard tuberculosis treatment in adults with pulmonary tuberculosis

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What is this study about?

This study focuses on patients with pulmonary tuberculosis, a serious lung infection caused by bacteria. The research investigates a new treatment approach that combines standard tuberculosis therapy with cysteamine (also known as Cystagon). This medication is being tested for a different use than its original approved purpose, which makes this an off-label study.

The purpose of this research is to determine if adding cysteamine to regular tuberculosis treatment is safe and well-tolerated by patients. The study involves taking cysteamine capsules by mouth along with standard tuberculosis medications. Participants will need to stay in the hospital for 4 weeks during the treatment period.

During the study, doctors will monitor how well patients tolerate the combined treatment and collect blood and other samples to understand how the medications work together. They will also track any side effects that may occur and measure how effectively the treatment fights the tuberculosis infection. The total duration of the study treatment and follow-up is 6 months.

1 Initial admission

You will be admitted to the hospital for a 4-week stay

Your treatment will include standard tuberculosis therapy combined with cysteamine (CYSTAGON 50 mg capsules taken by mouth)

If you are a woman of childbearing age, a pregnancy test will be performed before starting treatment

2 First week examinations

On day 0 (start), samples will be collected from your blood, urine, and sputum

Similar samples will be taken again on day 7 (plus or minus 1 day)

Your treatment response will be monitored through these samples

3 Ongoing monitoring

Additional sample collections will occur on days 14 and 28

Your medication intake will be directly observed by medical staff

Your body’s response to treatment will be carefully monitored

Any side effects will be recorded and evaluated

4 Extended follow-up

After hospital discharge, you will continue to be monitored at day 60

Final evaluation will take place at month 6

Blood and other samples will continue to be collected at these visits

Your body’s immune response to the treatment will be evaluated through blood tests

5 Contraception requirements

If you are of childbearing age, you must use contraception from 2 weeks before starting treatment

Contraception must continue until 18 weeks after receiving the experimental medication

Who Can Join the Study?

  • Must be between 18 and 65 years old
  • Must have signs and symptoms of newly diagnosed pulmonary tuberculosis
  • Must have chest X-ray showing signs of pulmonary tuberculosis
  • Must have positive sputum test for bacteria and confirmed presence of tuberculosis bacteria through DNA testing
  • Must show sensitivity to standard tuberculosis medications
  • Female participants must be unable to have children (through surgery or menopause). Menopause means no menstrual periods for 12 months naturally
  • Must weigh at least 50 kilograms
  • Must have a Karnofsky score of 60% or higher (this measures how well you can perform daily activities)
  • Must be able to understand and sign informed consent
  • Must be able to attend all follow-up appointments
  • Must agree to stay in hospital for 4 weeks
  • Must agree to take medication under direct observation
  • If able to have children, must agree to use contraception from 2 weeks before study start until 18 weeks after taking the study medicine
  • Women who can become pregnant must agree to pregnancy testing before starting study medicine

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Pregnant women or breastfeeding mothers
  • History of allergic reactions to cysteamine or similar medications
  • Severe liver disease or kidney problems
  • Current participation in other clinical trials
  • Having drug-resistant tuberculosis (TB that does not respond to standard medications)
  • Serious heart conditions or uncontrolled high blood pressure
  • Active substance abuse or addiction
  • Mental health conditions that could affect ability to follow study procedures
  • HIV infection or other serious immune system disorders
  • History of serious gastrointestinal problems
  • Taking medications that could interact with cysteamine
  • Unable to provide informed consent
  • History of non-compliance with medical treatment
  • Severe respiratory conditions other than tuberculosis

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
National Institute For Infectious Diseases Lazzaro Spallanzani Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
15.07.2024

Trial locations

Investigated drugs:

Cysteamine is a medication being studied as an additional treatment alongside standard tuberculosis therapy. It works differently from traditional TB medications by targeting the patient’s immune system (the host) rather than directly attacking the bacteria. This approach could potentially improve the effectiveness of standard tuberculosis treatment. Cysteamine is already known and used for other medical conditions, but in this trial, it’s being studied for a new use (off-label) in treating tuberculosis.

Standard Tuberculosis (TB) therapy is the established combination of antibiotics used to treat TB infections. This therapy typically includes several medications that work together to kill the tuberculosis bacteria. The standard treatment helps eliminate the infection and prevent the bacteria from becoming resistant to the medications.

Investigated diseases:

Pulmonary Tuberculosis – A bacterial infection caused by Mycobacterium tuberculosis that primarily affects the lungs. The disease typically develops gradually, with bacteria slowly multiplying in the lungs and creating small patches of infection. As the infection progresses, it can create small holes in the lung tissue and cause inflammation. Common manifestations include persistent cough, chest pain, and the production of mucus. The infection can spread within the lungs, causing areas of damaged tissue and inflammation to grow larger over time. The condition can be passed from person to person through air droplets when someone with active tuberculosis coughs or sneezes.

Trial ID:
2024-516088-10-00
Protocol code:
CISTA-TB
Trial Phase:
Therapeutic exploratory (Phase II)

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