Safer antibiotic dosing could protect kidneys in cystic fibrosis patients
NCT ID NCT02918409
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two common IV antibiotics, tobramycin and colistin, in 51 adults with cystic fibrosis to find the safest and most effective way to treat lung infections. Researchers compared a new, less frequent dosing schedule for colistin to standard care, aiming to reduce kidney damage while still fighting the infection. The goal is to improve long-term treatment safety for people with cystic fibrosis.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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51 people
The number who actually took part.
- Started
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Aug 2016
- Finished
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Nov 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. -
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Jewish Health
Denver, Colorado, 80206, United States
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