Study on the Safety and Effectiveness of CC-11050 and Metformin for Patients with Rifampin-Resistant Tuberculosis

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What is this study about?

This clinical trial is focused on studying treatments for rifampin-resistant pulmonary tuberculosis, a type of lung infection that does not respond to the usual antibiotic, rifampin. The study will test two additional treatments alongside standard care. One treatment is an anti-inflammatory drug with the code name CC-11050, which is designed to reduce inflammation in the body. The other treatment is Metformin, a medication commonly used to treat diabetes, which may have additional benefits in fighting infections.

The purpose of the study is to explore the safety and initial effectiveness of these two treatments in helping patients recover lung function and clear the infection. Participants will be randomly assigned to receive either the new treatments or a placebo, in addition to their regular tuberculosis medication. The study will last for up to 24 months, with regular check-ups to monitor health and progress.

Throughout the study, doctors will assess how well the treatments work by looking at lung function and the ability to clear the tuberculosis infection. The goal is to find out if these additional treatments can help improve outcomes for patients with this challenging form of tuberculosis. The study will compare the results of those taking CC-11050 and Metformin to those who do not receive these additional treatments.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests to ensure the presence of rifampin-resistant pulmonary tuberculosis.

Eligibility criteria include being between 16 and 65 years old, having a body weight between 30 and 90 kg, and a positive sputum test for tuberculosis with rifampin resistance.

2 treatment allocation

Participants are randomly assigned to one of the treatment groups. The study investigates two therapies: an anti-inflammatory and an antimicrobial treatment.

The medications used include Metformin Zentiva 500 mg film-coated tablets, taken orally. The specific dosage and frequency are determined by the study protocol.

3 treatment phase

During the treatment phase, participants take the assigned medication as directed. The treatment aims to improve lung function and eradicate the tuberculosis infection.

Regular follow-up visits are scheduled to monitor safety, tolerability, and the effectiveness of the treatment. These visits include physical examinations and laboratory tests.

4 evaluation of primary endpoints

At month 6, the primary endpoints are evaluated. These include the recovery of lung function and the eradication of the tuberculosis infection.

The success of the treatment is determined by meeting both co-primary endpoints: improvement in lung function and stable culture conversion.

5 long-term follow-up

Participants continue to be monitored for up to 18 months after entering the study. This long-term follow-up assesses the durability of the treatment effects and any potential long-term side effects.

The study is expected to conclude by December 31, 2025.

Who Can Join the Study?

Must be between the ages of 16 and 65.
Must be able and willing to provide signed written consent. If unable to write, verbal consent from witnesses is acceptable. For those aged 16 or 17, consent from a parent or guardian is also required.
Body weight should be between 30 and 90 kg (measured in light clothing without shoes).
Must have a positive sputum test for tuberculosis (TB) using a test called Xpert, with a specific result called Ct ≤22, and this must be confirmed by a culture test.
Must have resistance to a TB medication called Rifampicin, confirmed by specific tests (Xpert, Hain test, or phenotypic drug susceptibility testing).
Must have a chest X-ray that meets criteria for moderate or very advanced pulmonary tuberculosis as defined by the National TB Association.
If sexually active, must be willing to use an effective method of birth control during TB treatment.
Must be HIV-1 seronegative (not infected with HIV-1), or if HIV-1 seropositive (infected with HIV-1), must be at an African study site with a CD4 T-cell count greater than 100/μl and either currently receiving ART (antiretroviral therapy) or willing to start ART during the study. Note: HIV+ patients will only be enrolled in African sites.

Who Cannot Join the Study?

Patients who do not have multidrug-resistant pulmonary tuberculosis cannot participate. This means the tuberculosis in their lungs does not resist multiple drugs used for treatment.
Patients who are not resistant to Rifampicin cannot participate. Rifampicin is a common antibiotic used to treat tuberculosis.
Patients who are not within the specified age range cannot participate. The study includes certain age groups only.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Institutul De Pneumoftiziologie Marius Nasta	Bucharest	Romania

Trial status

Country	Status	Recruitment Start
Romania	Not recruiting	23.01.2025

Trial locations

Investigated drugs:

Metformin Hydrochloride

CC11050 is an anti-inflammatory medication being tested to see if it can help reduce inflammation in patients with rifampin-resistant tuberculosis. The goal is to see if it can improve lung function and help clear the infection more effectively when used alongside standard tuberculosis treatments.

Metformin is an antimicrobial medication commonly used to treat diabetes, but in this trial, it is being tested for its potential to help fight tuberculosis infection. Researchers are investigating whether it can enhance the effectiveness of tuberculosis treatment and improve recovery of lung function in patients with rifampin-resistant tuberculosis.

Multidrug-Resistant Pulmonary Tuberculosis – This is a form of tuberculosis that affects the lungs and is resistant to at least two of the most powerful anti-TB drugs, including rifampicin. The disease is caused by the bacterium Mycobacterium tuberculosis, which primarily attacks the lungs but can also affect other parts of the body. It spreads through the air when an infected person coughs or sneezes. The progression of the disease can lead to severe lung damage, causing symptoms such as a persistent cough, chest pain, and difficulty breathing. Over time, if untreated, it can result in significant respiratory issues and reduced lung function. The disease requires specialized treatment due to its resistance to standard medications.

Trial ID:

2025-520745-80-00

Protocol code:

AUR1-1-313 DRTB-HDT

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of CC-11050 and Metformin for Patients with Rifampin-Resistant Tuberculosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?