Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis
Brief Summary: Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.


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 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).
C: 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.
D: Inclusion Criteria:

* Diagnosis of CF, as determined by the 1997 CF Consensus Conference criteria: sweat chloride level greater than 60 milliequivalent/liter (mEq/L) by quantitative pilocarpine iontophoresis; or a genotype with two identifiable mutations consistent with CF; or an abnormal nasal transepithelial potential difference and one or more clinical features consistent with CF
* For participants greater than 15 months of age: documented new onset of positive oropharyngeal, sputum, or lower respiratory tract culture for PA within 6 months of study entry, defined as either: 1) first lifetime documented PA positive culture; or 2) PA recovered after at least a 2-year history of PA negative respiratory cultures (at least one culture per year)
* For participants 12-15 months of age: at least one documented positive oropharyngeal, sputum, or lower respiratory tract culture for PA since birth or CF diagnosis
* Clinically stable with no evidence of any significant respiratory symptoms or chest radiograph findings at screening that would require administration of intravenous anti-pseudomonal antibiotics, oxygen supplementation, or hospitalization

Exclusion Criteria:

* History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside
* History of hypersensitivity or adverse reaction to ciprofloxacin or other fluoroquinolone medications
* History of persistent, unresolved hearing loss documented by audiometric testing on at least two occasions and not associated with middle ear disease or an abnormal tympanogram
* Abnormal kidney function at study entry (defined as a serum creatinine level greater than 1.5 times the upper limit of normal for participant's age)
* Abnormal liver function test results at study entry (defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels greater than two times the upper limit of normal range)
* Use of any investigational drug within 30 days of study entry
* Use of loop diuretics, phenytoin, warfarin, theophylline, or other methylxanthines within 30 days of study entry
* Use of more than one course of intravenous anti-pseudomonal antibiotics (at least 10 continuous days of medication use) or more than one course of inhaled anti-pseudomonal antibiotics (at least 28 continuous days of medication use) within 2 years of study entry; intravenous or inhaled anti-pseudomonal antibiotics must be stopped at least 30 days prior to study entry
* Chronic macrolide use (more than 90 day duration) in the 3 months prior to study entry
* Presence of a condition or abnormality that would compromise the participant's safety or the quality of the study data, in the opinion of the investigator

Answer: D