Male or female = 18 years of age at Visit 1.
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.
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.
Respiratory culture(s) demonstrating evidence of Pseudomonas aeruginosa or Achromobacter species airway infection.
Subject is able to produce sputum, undergo phlebotomy, and provide written consent.
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.

NCT02918409_inc_T1
Person
Male
NCT02918409_inc_T2
Person
female
NCT02918409_inc_T3
Person
age
NCT02918409_inc_T4
Temporal
at Visit 1.
NCT02918409_inc_T5
Reference_point
Visit 1
NCT02918409_inc_T6
Value
= 18 years
NCT02918409_inc_T7
Measurement
Sweat chloride
NCT02918409_inc_T8
Value
equal or greater than 60 mEq/L
NCT02918409_inc_T9
Measurement
quantitative pilocarpine iontophoresis test
NCT02918409_inc_T10
Multiplier
Two
NCT02918409_inc_T11
Condition
mutations
NCT02918409_inc_T12
Condition
stic fibrosis transmembrane conductance regulator ( ne
A
NCT02918409_inc_T13
Condition
CFTR
NCT02918409_inc_T14
Measurement
nasal potential difference
NCT02918409_inc_T15
Measurement
NPD
NCT02918409_inc_T16
Value
Abnormal
NCT02918409_inc_T17
Value
less than -5 mV
NCT02918409_inc_T19
Condition
acute pulmonary exacerbation
NCT02918409_inc_T20
Measurement
CF Foundation guidelines
NCT02918409_inc_T22
Measurement
Respiratory culture(s)
NCT02918409_inc_T23
Value
Pseudomonas aeruginosa
NCT02918409_inc_T24
Value
Achromobacter species
NCT02918409_inc_T25
Scope
Pseudomonas aeruginosa or Achromobacter species
NCT02918409_inc_T26
Condition
airway infection