Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung
NCT ID: NCT02113397
Last Updated: 2018-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1 participants
OBSERVATIONAL
2014-04-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Continuous Therapy
TOBIâ„¢ Podhalerâ„¢ 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.
TOBIâ„¢ Podhalerâ„¢ 112 mg inhaled twice daily
Colistimethate 75 mg inhaled two times daily
Cyclic therapy
TOBIâ„¢ Podhalerâ„¢ 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.
TOBIâ„¢ Podhalerâ„¢ 112 mg inhaled twice daily
Interventions
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TOBIâ„¢ Podhalerâ„¢ 112 mg inhaled twice daily
Colistimethate 75 mg inhaled two times daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Alex H. Gifford
Assistant Professor of Medicine
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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References
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Filkins LM, Hampton TH, Gifford AH, Gross MJ, Hogan DA, Sogin ML, Morrison HG, Paster BJ, O'Toole GA. Prevalence of streptococci and increased polymicrobial diversity associated with cystic fibrosis patient stability. J Bacteriol. 2012 Sep;194(17):4709-17. doi: 10.1128/JB.00566-12. Epub 2012 Jun 29.
Price KE, Hampton TH, Gifford AH, Dolben EL, Hogan DA, Morrison HG, Sogin ML, O'Toole GA. Unique microbial communities persist in individual cystic fibrosis patients throughout a clinical exacerbation. Microbiome. 2013 Nov 1;1(1):27. doi: 10.1186/2049-2618-1-27.
Other Identifiers
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CTBM100DUS02T
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
D14010
Identifier Type: -
Identifier Source: org_study_id
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