Phase 1 Cystic Fibrosis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For people with CF who have never been treated for NTM (Treatment-Naïve group):

• People of any gender aged 18 or older at the first study visit who are willing and able to sign a consent form
• People who are willing and able to follow the study schedule and meet all study requirements
• People who have a confirmed diagnosis of cystic fibrosis (CF)
• People whose lung mucus (sputum) or airway fluid samples have repeatedly tested positive for a type of bacteria called nontuberculous mycobacteria (NTM) — specifically M. avium complex, M. abscessus complex, or both — with two or more positive results taken at least 28 days apart, or meeting a specific pattern of positive results over recent months (confirm with trial site for exact details)
• People whose current NTM type has never been treated before, or whose previous NTM treatment led to clearance of the infection and was completed more than 2 years before the study start date
• People whose lung function test (called FEV1) shows the lungs are working at 25% or more of the expected level for their age and size
• People who are able to cough up sputum (mucus) on their own
• People who have been in a stable state of health with no significant changes in the 7 days before the study start date
• People who are enrolled in the Cystic Fibrosis Foundation (CFF) Patient Registry
• People who are willing to stop taking azithromycin as a long-term medication for the full duration of the study

For people with CF whose NTM has not responded to treatment (Treatment-Refractory group):

• People of any gender aged 18 or older at the first study visit who are willing and able to sign a consent form
• People who are willing and able to follow the study schedule and meet all study requirements
• People who have a confirmed diagnosis of cystic fibrosis (CF)
• People who have a history of current or past treatment for NTM lung disease caused by M. abscessus, M. avium, or both — either having previously received standard antibiotic treatment for more than 12 months without the infection clearing, or currently still receiving that treatment after more than 12 months
• People whose lung function test (FEV1) shows the lungs are working at 25% or more of the expected level for their age and size
• People who are able to cough up sputum (mucus) on their own
• People who have not been hospitalised in the 7 days before the study start date
• People who are enrolled in the Cystic Fibrosis Foundation (CFF) Patient Registry
• People who are currently receiving standard antibiotic treatment for NTM and are willing and able to continue that treatment alongside the study drug (intravenous gallium)

Who may not be able to join:

For both groups, the following apply:

• People whose blood test results at screening show certain abnormal levels, including: low red blood cell levels (haemoglobin below 10g/dL), low platelet counts, low levels of a type of white blood cell (neutrophils), significantly elevated liver-related markers in the blood, or kidney function values outside acceptable ranges (confirm specific thresholds with trial site)
• People who have previously had a transplant of a solid organ (such as a kidney, liver, or heart) or a blood/bone marrow transplant
• People who have used a type of bone medication called bisphosphonates in the 7 days before the study start date
• People who are known to have a sensitivity (allergic-type reaction) to gallium
• People who have taken part in another clinical trial involving an experimental treatment within 28 days before the study start date
• People who have a current diagnosis of osteoporosis (weakened/thinning bones)
• People who are pregnant, breastfeeding, or who are unwilling to use an accepted form of contraception during the study (unless they have been surgically sterilised or are postmenopausal) — accepted methods include abstinence, hormonal birth control, an intrauterine device (IUD), or a barrier method used with a spermicide
• People who are able to father a child and are unwilling to use adequate contraception during the study, as determined by the study doctor
• People who have started a new long-term CF medication (such as CFTR modulators, inhaled antibiotics, or similar treatments) within 28 days before the first study visit
• People who have any other condition that, in the opinion of the study investigator, would make participation unsafe, interfere with study results, or prevent the person from giving proper informed consent

For the Treatment-Naïve group only:

• People who, in the opinion of the study investigator, show signs of active NTM disease that appears to be causing their health to worsen
• People who are currently receiving treatment for NTM disease, or who expect to begin such treatment within 3 months
• People who have taken azithromycin in the 14 days before the screening visit

Important: Always verify eligibility with the trial site directly before applying.