Is NCT04294043 recruiting in Denver, CO?

Yes, NCT04294043 is currently recruiting participants at its Denver, CO location. This nontuberculous mycobacterium infection clinical trial is actively enrolling qualified participants.

Is participation in this Denver 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.

Nontuberculous Mycobacterium Infection Clinical Trial in Denver, CO

Q: How do I join the nontuberculous mycobacterium infection clinical trial in Denver?

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

Who Can Participate

Inclusion Criteria

for Treatment-Naïve NTM Cohort

Written informed consent obtained from participant or participant's legal representative

Be willing and able to adhere to the study visit schedule and other protocol requirements

All genders ≥ 18 years of age at Visit 1

Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype

Documentation of persistently positive NTM culture results that are positive for the same species or sub-species (either M. avium complex, M. abscessus complex, or both M. avium and M. abscessus). Persistently positive cultures are those which meet ONE of the following criteria, after first ignoring any negative culture results that occur within 7 days of a positive culture:

The two most recent NTM culture results from sputum or BAL taken at least 28 days apart are positive. OR

At least one NTM culture result in the previous 4 months from sputum or BAL is positive. If there are four or more cultures in the last 12-months at least 3 out of the 4 most recent cultures must be positive for NTM. If there are three or fewer cultures in the past 12 months, then at least 2 of the 3 most recent cultures must be positive for NTM even if some of those cultures are more than 12 months ago.

Current NTM species or subspecies has never been treated or previous treatment was associated with clearance of NTM and completed \> 2 years prior to Day 1

FEV1 ≥ 25 % of predicted value at Screening

Able to expectorate sputum

Clinically stable with no significant changes in health status within 7 days prior to Day 1

Enrolled in the CFF Patient Registry (CFF PR)

Willing to discontinue chronic azithromycin use for the duration of the study Inclusion Criteria for Treatment-Refractory NTM Cohort

Written informed consent obtained from participant or participant's legal representative

Be willing and able to adhere to the study visit schedule and other protocol requirements

All genders ≥ 18 years of age at Visit 1

Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype

History of current or prior treatment for NTM pulmonary disease with M. abscessus or M avium (or both M. avium and M. abscessus)

Previously received treatment with guideline-based antibiotics for \>12 months without having treatment discontinued for reasons of culture clearance OR

Currently receiving treatment with guideline-based antibiotics for \>12 months

FEV1 ≥ 25 % of predicted value at Screening

Able to expectorate sputum

Not hospitalized within 7 days prior to Day 1

Enrolled in the CFF Patient Registry (CFF PR)

Be willing and able to continue guideline-based antibiotic therapy for M. abscessus or M avium (or both M. avium and M. abscessus) concurrent with IV gallium, if currently on treatment

Exclusion Criteria

Treatment-Naïve NTM Cohort

Any of the following abnormal lab values at screening:

Hemoglobin \<10g/dL

Platelets \<100,000/mm3

Absolute neutrophil count \< 1500/mm3

Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), or total bilirubin ≥3 x upper limit of normal

Serum creatinine \> 2.0 mg/dl and ≥1.5 x upper limit of normal

Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal)

History of solid organ or hematological transplantation

Use of bisphosphonates within 7 days prior to Day 1

Known sensitivity to gallium

Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1

In the opinion of the Investigator, features of active NTM disease are present (e.g., clinical worsening is likely due to NTM disease despite definitive treatment of co-pathogens and/or acute exacerbations)

Undergoing treatment for NTM disease or anticipate beginning treatment within 3 months

Current diagnosis of osteoporosis

For people of childbearing potential:

Positive pregnancy test at Visit 1 or

Lactating or

Unwilling to practice a medically acceptable form of contraception (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal during the study

For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study

Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

New initiation of chronic CF therapy (e.g., CFTR modulators, ibuprofen, azithromycin, inhaled tobramycin, Cayston, etc.) within 28 days prior to Visit 1 (Day 1)

Use of azithromycin within 14 days prior to the screening visit Exclusion Criteria Treatment-Refractory NTM Cohort

Any of the following abnormal lab values at screening:

Hemoglobin \<10g/dL

Platelets \<100,000/mm3

Absolute neutrophil count \< 1500/mm3

Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), or total bilirubin ≥3 x upper limit of normal

Serum creatinine \> 2.0 mg/dL and ≥1.5 x upper limit of normal

Ionized calcium ≤ lower limit of normal (only performed if total calcium is ≤ lower limit of normal)

History of solid organ or hematological transplantation

Use of bisphosphonates within 7 days prior to Day 1

Known sensitivity to gallium

Use of any investigational drug and/or participated in any interventional clinical trial within 28 days prior to Day 1

Current diagnosis of osteoporosis

For people of childbearing potential:

Positive pregnancy test at Visit 1 (Day 1) or

Lactating or

For people able to father a child: unwilling to use adequate contraception (as determined by the investigator) during the study

New initiation of chronic CF therapy (e.g., CFTR modulators, ibuprofen, inhaled tobramycin, Cayston, etc.) within 28 days prior to Visit 1 (Day 1)

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 Denver?

Yes, this clinical trial (NCT04294043) has an active research site in Denver, CO 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.

Nontuberculous Mycobacterium Infection Treatment Options in Denver, CO

If you're searching for nontuberculous mycobacterium infection treatment options in Denver, CO, this clinical trial (NCT04294043) 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 Denver research site is actively enrolling participants for this clinical trial. You'll receive care from experienced nontuberculous mycobacterium 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 nontuberculous mycobacterium infection clinical trials near you to find additional studies recruiting in your area.

Nontuberculous Mycobacterium Infection Clinical Trial in Denver, CO

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About This Nontuberculous Mycobacterium Infection Study in Denver