IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy
Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to find the safest and most effective way to administer IV
antibiotics to treat acute pulmonary exacerbations (APEs) in patients with cystic fibrosis
(CF) that are caused by pathogens, like Pseudomonas aeruginosa. This study will test the
safety and effectiveness of two commonly prescribed IV antibiotics: tobramycin and colistin.
Though regularly used, not much is known about how these drugs compare with each other in
terms of their toxicities, both during short term treatment of an APE and after many
treatment courses with these drugs over many years. There are currently no guidelines on the
safest and most effective antibiotics to use when treating APEs. We will study kidney
function, sputum cultures, and treatment outcomes in patients receiving routine
administration of one of these two IV antibiotics. We will also test these outcomes in
patients receiving a less frequent dosing schedule for IV colistin. The hope is that this new
schedule for IV colistin, which is twice a day and adjusted based on blood and urine tests,
will reduce harmful side effects, such as kidney damage, while still being a powerful
treatment against CF microbial pathogens.