Is NCT07094711 recruiting in Charlottesville, VA?

Yes, NCT07094711 is currently recruiting participants at its Charlottesville, VA location. This mycobacterium avium-intracellulare infection clinical trial is actively enrolling qualified participants.

Is participation in this Charlottesville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Mycobacterium Avium-intracellulare Infection Clinical Trial in Charlottesville, VA

Q: How do I join the mycobacterium avium-intracellulare infection clinical trial in Charlottesville?

To join this clinical trial in Charlottesville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Mycobacterium Avium-intracellulare Infection Study in Charlottesville

The purpose of this study is to find out if the Mycobacterium bovis Bacillus Calmette Guerin (BCG) vaccine can be used safely to treat Mycobacterium avium complex (MAC) lung disease. Researchers will compare responses from patients with MAC lung disease after receiving an injection of BCG or placebo (a look-alike substance that contains no drug) Participants in the study: * Receive a BCG or placebo injection at UVA study center on Day 0 * Come to UVA study center on Day 60 * Come to UVA study center at the end of the study * Answer surveys and questionnaires about how you are doing * Have blood drawn 3 times, on injection day, day 60, and at end of study * Give the study team personal and demographic information * Discuss any new symptoms with the study team * Provide monthly sputum samples per usual care

Sponsor: University of Virginia

Who Can Participate

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Male or female aged ≥18 years

Mycobacterium avium complex lung disease as evidenced by diagnosis or treatment for MAC lung disease by pulmonologist or infectious disease physician in the medical record. The following data will be extracted from the medical record:

History of at least 2 MAC positive respiratory cultures, one of which is within 1 year of enrollment. In the event a MAC positive culture is from bronchial lavage or biopsy, one culture rather than 2 will meet criteria.

Respiratory and/or constitutional symptoms consistent with MAC lung disease

Nodular or cavitary opacities on chest radiograph or bronchiectasis with multiple small nodules on high-resolution computed tomography

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures

Women of childbearing potential (WOCBP) (i.e., fertile following menarche and until becoming postmenopausal unless permanently sterile) agree to practice a highly effective method of birth control from Day 0 to at least 90 days after study intervention. Some examples of acceptable birth controls are:

True abstinence (refraining from heterosexual intercourse during the entire study),

Copper intrauterine device (IUD),

Hormonal methods (levonorgestrel-releasing intrauterine system, progestogen implant, combined oral contraceptive pill \[combined with barrier method\]), exclusive homosexual relationship) sole male partner who has undergone surgical sterilization

Exclusion Criteria

Selection of study participants will be equitable, but an individual who meets any of the following criteria will be excluded from participation in this study:

Currently receiving antibiotics prescribed for their MAC lung disease

Having received any antibacterial antibiotics within the past 14 days prior to study vaccination, day 0

Known allergy, intolerance or other contraindication to isoniazid or rifampin or ethambutol

Expectation of starting anti-MAC lung disease antibiotics in the next 2 months per patient or their physician

Persons with congenital or acquired immune deficiencies (e.g., HIV infection; leukemia, lymphoma, or cancer therapy within the past 2 years; immunosuppressive therapy such as anti B cell depleting therapies, corticosteroids (\>20 mg/day for \> 14 days), dupilumab, elivaldogene, etrasimod, cytotoxic chemotherapy, miscellaneous oncologic agents, therapeutic immunosuppressant agents, methotrexate, teplizumab, tezepelumab, tildrakizumab, tralokinumab, ustekinumab). Persons with lung and other solid organ transplants/hematologic stem cell transplants who may be contraindicated to receive a live vaccine. Point of care HIV testing must be negative at baseline.

Prior BCG Vaccination. If unknown Bcgatlas.org shall be consulted for local vaccination administration policies.

Known pregnancy at the time of screening or breastfeeding at the time of enrollment (pregnancy test negative at baseline if applicable)

Cystic fibrosis

Active tuberculosis: Active tuberculosis (respiratory AFB culture growing Mycobacterium tuberculosis complex within the past 4 months).

Known exposure to a case of active pulmonary tuberculosis within 10 weeks of enrollment

Known prior hypersensitivity reaction to BCG or any component of the BCG vaccine

Received live injectable vaccine within 28 days of day 0 study vaccination

Any condition in the opinion of the investigator that may confound the study endpoints Note that colonization or co-infection with other nontuberculous mycobacteria is not exclusionary, as MAC will be the endpoint.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charlottesville?

Yes, this clinical trial (NCT07094711) has an active research site in Charlottesville, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Mycobacterium Avium-intracellulare Infection Treatment Options in Charlottesville, VA

If you're searching for mycobacterium avium-intracellulare infection treatment options in Charlottesville, VA, this clinical trial (NCT07094711) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charlottesville research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced mycobacterium avium-intracellulare infection specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all mycobacterium avium-intracellulare infection clinical trials near you to find additional studies recruiting in your area.

Mycobacterium Avium-intracellulare Infection Clinical Trial in Charlottesville, VA

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