Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis
Brief Summary: The goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study.


Options:
A: Inclusion Criteria (selected):

* \> 16 years of age
* Confirmed Diagnosis of Cystic Fibrosis
* Positive sputum culture for P. aeruginosa within the past 18 months
* Patients are able to elicit a forced expiratory volume in 1 second (FEV1) \>/= 25% but \</= 85% of predicted value at screening
* Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months
* Clinically stable with no changes in health status within the last 30 days
* Able to reproducibly produce sputum and perform spirometry

Exclusion Criteria (selected):

* Use of any nebulized or systemic antibiotics within 30 days prior to baseline
* History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
* Evidence of acute upper within 10 days or lower respiratory infections within 30 days prior to dosing
* Creatine clearance \< 50mg/ml, aspartate transaminase (AST), alanine transaminase (ALT) or total bilirubin \>/= 3 x upper limit of normal (ULN) at Screening
B: Inclusion Criteria:

* Male or female ages less than or equal to 12 years.
* Diagnosis of CF based upon the criteria established by the 1997 CF Consensus Conference: (i) sweat chloride \> 60 mEq/L by quantitative pilocarpine iontophoresis; or (ii) genotype with two identifiable mutations consistent with CF; or (iii) an abnormal nasal transepithelial potential difference, and (iv) one or more clinical features consistent with CF.
* No prior isolation of Pa from respiratory cultures (1 or more cultures in 24 months prior to enrollment), or, if prior isolation of Pa from respiratory cultures, at least a two-year history of Pa negative cultures (1 or more cultures/year), or concurrently enrolled in the EPIC Clinical Trial.
* Signed informed consent to participate in data submission to the CFF National Patient Registry.
* Signed informed consent by parent or legal guardian.
C: Inclusion criteria:

* Male or female patients ≥ 6 months old
* Diagnosis of cystic fibrosis (CF) based upon the following historical criteria performed prior to study participation:

  1. confirmed sweat chloride \> 60 mEq/L by quantitative pilocarpine iontophoresis (at least 2 tests), OR
  2. genotype with two identifiable mutations consistent with CF.
* First or early lower respiratory tract infection with Pseudomonas (P.) aeruginosa documented by either of the following:

  1. first infection defined by the first P. aeruginosa isolated from sputum or deep throat cough swab culture, OR
  2. P. aeruginosa from sputum or deep throat cough swab culture following at least 1 year of negative cultures (documented with at least 4 negative cultures during this year and no positive cultures) and no anti-pseudomonal treatment during this 1-year period, OR
  3. P. aeruginosa from sputum or deep throat cough swab culture following at least 2 years of negative cultures (documented with at least 2 negative cultures per year and no positive cultures) and no anti-pseudomonal treatment during this 2-year period.
* Written informed consent by the patient and/or parent/legal guardian according to local country regulations.

Exclusion criteria:

* History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside.
* Signs and symptoms of acute pulmonary disease, eg, pneumonia, pneumothorax.
* Administration of any investigational drug within 30 days prior to enrollment.
* Administration of loop diuretics within 7 days prior to study drug administration.
* Personal/family history of abnormal hearing, other than typical hearing loss associated with the aging process.
* Abnormal result from an audiology testing (defined as either a unilateral pure-tone audiometry test showing a threshold elevation \> 20 decibels \[dB\] at any frequency across the frequency range 0.25-8 kHz or the absence of emission at the evoked otoacoustic emission test).
* Positive urine pregnancy test at Day 1 (Baseline) for all female patients who have reached menarche.
* Use of macrolide antibiotics as a maintenance therapy for 12 or more days during the 28 days prior to Baseline.
* Antibody titers ≥ 1000 for any of the 3 P. aeruginosa exoenzymes: Exotoxin A, alkaline protease, or elastase (status to be determined between Baseline and Day 28).
D: Inclusion Criteria:

* Male or female ≥12 years of age at Visit 1
* Enrolled in the CFFNPR (Patients may enroll in the Registry at Visit 1 if not previously enrolled.)
* Current hospitalization for treatment of a pulmonary exacerbation
* Planned hospital admission of at least 5 days with intravenous (IV) antibiotics at Visit 1
* Able to perform spirometry at admission and willing to perform spirometry on subsequent treatment and visit days
* Willing and able to complete symptom score daily
* Willing to return for a follow up visit at end of treatment (if necessary) and 28 days after start of IV antibiotic therapy
* Written informed consent (and assent when applicable) obtained from the participant or participant's legal representative

Exclusion Criteria:

* Previous enrollment in this study
* Treatment with IV antibiotics in the 6 weeks prior to Visit 1
* Admission to the intensive care unit for current pulmonary exacerbation
* Pneumothorax on admission
* Current hospitalization for scheduled pulmonary clean out
* Current hospitalization for sinusitis as the primary diagnosis
* Massive hemoptysis defined as \> 250 cc in a 24 hour period, or 100 cc/day over 4 consecutive days occurring within one week of Visit 1
* Current pulmonary exacerbation thought to be due to allergic bronchopulmonary aspergillosis (ABPA)
* Ongoing treatment with prednisone equivalent \>10 mg/day for greater than 2 weeks initiated prior to Visit 1
* History of solid organ transplantation Currently receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g., M. abscessus, M. avium complex)

Answer: D