IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/15/2019 |
| Start Date: | August 2016 |
| End Date: | July 2021 |
| Contact: | Katie Poch |
| Email: | pochk@njhealth.org |
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.
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.
Inclusion Criteria:
1. Male or female ≥ 18 years of age at Visit 1.
2. Documentation of CF diagnosis as evidenced by one or more clinical features consistent
with the CF phenotype and one or more of the following criteria:
- Sweat chloride equal or greater than 60 mEq/L by quantitative pilocarpine
iontophoresis test.
- Two well-characterized mutations in the cystic fibrosis transmembrane conductance
regulator (CFTR) gene
- Abnormal nasal potential difference (NPD) as measured by a change in NPD in
response to a low chloride solution and isoproterenol of less than -5 mV.
3. Documentation of the presence of an acute pulmonary exacerbation, based on CF
Foundation guidelines, as diagnosed by a faculty member of the Denver Adult CF
Program.
4. Respiratory culture(s) demonstrating evidence of Pseudomonas aeruginosa or
Achromobacter species airway infection.
5. Subject is able to produce sputum, undergo phlebotomy, and provide written consent.
6. The subject's treating physician has determined that they should receive either
tobramycin or colistin intravenously as one of the designated agents for their APE
treatment. Subjects who are able to receive either tobramycin or colistin as part of
their antibiotic regimen will be randomized into one of three arms. If a treating
physician deems that a subject cannot receive tobramycin due to vestibular toxicity,
ototoxicity or bacterial resistance, the subject will be randomized to either standard
or PK-adjusted colistin.
Exclusion Criteria:
1. Concomitant administration of bactrim (due to effects on creatinine).
2. Concomitant administration of inhaled colistin for patients in the colistin PK arm, as
this will create inaccuracies in colistin sputum concentration measurements.
3. Patients being treated for B. cepacia, due to colistin resistance by the pathogen.
4. Presence of chronic renal insufficiency, with abnormal baseline creatinine >1.2mg/dL.
5. Presence of a condition or abnormality that in the opinion of the investigator would
compromise the safety of the patient or the quality of the data.
6. Inability to perform reproducible spirometry.
7. Inability to expectorate sputum. -
We found this trial at
1
site
1400 Jackson St
Denver, Colorado 80206
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Milene Saavedra, MD
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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