Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung

Stopped early

Conditions studied: Cystic Fibrosis

In brief

The purpose of this study is to characterize bacterial diversity and richness in the sputum of cystic fibrosis patients treated with every-other-month TOBI™ Podhaler™ and continuous alternating therapy with TOBI™ Podhaler and colistimethate (Colistin).

Key facts

Study ID

NCT02113397

Run by

Dartmouth-Hitchcock Medical Center

People needed

1

Starts

2014-04-01

Expected to finish

2016-08-01

Last updated by the study team

2018-03-12

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of cystic fibrosis confirmed by mutation analysis of the cystic fibrosis transmembrane conductance regulator gene
• Sputum or throat swab culture positive for Pseudomonas aeruginosa at or within 6 months of enrollment
• Age ≥12 years
• Forced expiratory volume in one second (FEV1) 25-90 percent-predicted

You may not qualify if…

• Age <18 years
• Inability to routinely expectorate sputum without induction by hypertonic saline
• Inability to provide or withdrawal of written informed consent
• History of aminoglycoside sensitivity or adverse reaction to inhaled antibiotics
• Serum creatinine ≥ 2.0 mg/dl
• Serum blood urea nitrogen (BUN) ≥40 mg/dl
• Pregnancy or lactating at screening
• History of systemic intravenous anti-Pseudomonal antibiotics within 28 days of enrollment

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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