Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung
Terminated
- Conditions
- Cystic Fibrosis
- Interventions
- Drug: TOBI™ Podhaler™ 112 mg inhaled twice daily
- Registration Number
- NCT02113397
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Continuous Therapy Colistimethate 75 mg inhaled two times daily TOBI™ Podhaler™ 112 mg inhaled by mouth twice daily for 30 days followed by a 30-day cycle colistimethate 75 mg inhaled two times daily. Repeat cycle. Cyclic therapy TOBI™ Podhaler™ 112 mg inhaled twice daily TOBI™ Podhaler™ 112 mg inhaled by mouth twice daily for 30 days followed by a 30-day period during which no inhaled antibiotics are used. Repeat cycle. Continuous Therapy TOBI™ Podhaler™ 112 mg inhaled twice daily TOBI™ Podhaler™ 112 mg inhaled by mouth twice daily for 30 days followed by a 30-day cycle colistimethate 75 mg inhaled two times daily. Repeat cycle.
- Primary Outcome Measures
Name Time Method Simpson Diversity Index 6 months The primary estimate in our study is the mean effects of Continuous Alternating Therapy compared to Cyclic therapy on Simpson Diversity Index (SDI) averaged at month 6
- Secondary Outcome Measures
Name Time Method Bacterial Relative Abundance 6 months Using 454 pyrosequencing and quantitative polymerase chain reaction (qPCR) techniques, the relative abundance of various bacterial genera will be determined.
Trial Locations
- Locations (1)
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States