IV Gallium for Cystic Fibrosis and NTM Infections

(ABATE Trial)

This trial tests the safety of using an IV infusion of gallium nitrate for individuals with cystic fibrosis (CF) who have a persistent lung infection caused by NTM bacteria. Researchers aim to determine if two 5-day cycles of this treatment are safe and well-tolerated by patients. It suits adults with CF who have ongoing NTM infections, either untreated or not cleared by previous treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

If you are in the treatment-naïve group, you must stop taking azithromycin for the study duration. If you are in the treatment-refractory group, you can continue your current guideline-based antibiotic therapy while participating in the trial.

Research has shown that IV gallium is generally safe for people with cystic fibrosis who have infections. One study found that patients tolerated the treatment well when administered over 5 days, with no major safety issues reported. This suggests the treatment is usually well-tolerated, though minor side effects might occur, as with any medication. Further studies are underway to confirm these results, but the initial findings are promising for those considering participation in clinical trials.¹²³⁴⁵

Researchers are excited about gallium nitrate for cystic fibrosis and NTM infections because it offers a unique approach compared to standard antibiotics. Unlike typical treatments that target bacterial cell walls, gallium nitrate disrupts the bacteria's ability to use iron, which is essential for their growth and survival. Additionally, this treatment is administered intravenously over a short, five-day cycle, potentially offering faster results. The innovative mechanism and delivery method of gallium nitrate could provide a new hope for patients resistant to conventional therapies.

Research has shown that IV gallium nitrate, which participants in this trial will receive, might help treat infections in people with cystic fibrosis (CF). One study found that a 5-day treatment was safe and reduced the amount of bacteria in the lungs of CF patients. However, another study did not find a significant improvement in lung function, as it did not notably change breathing test results. The main focus has been on its safety and patient tolerance. While more research is needed to confirm its effectiveness, early results suggest it might help reduce lung infections.¹³⁶⁷⁸