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| ID | Type | Description | Link |
|---|---|---|---|
| CTBM100DUS02T | Other Grant/Funding Number | Novartis Pharmaceuticals |
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Insufficient enrollment
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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The purpose of this study is to characterize bacterial diversity and richness in the sputum of cystic fibrosis patients treated with every-other-month TOBIâ„¢ Podhalerâ„¢ and continuous alternating therapy with TOBIâ„¢ Podhaler and colistimethate (Colistin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOBIâ„¢ Podhalerâ„¢ 112 mg inhaled twice daily | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Simpson Diversity Index | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Relative Abundance | Using 454 pyrosequencing and quantitative polymerase chain reaction (qPCR) techniques, the relative abundance of various bacterial genera will be determined. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with cystic fibrosis who are followed at Dartmouth-Hitchcock Medical Center
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22753064 | Background | 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. | |
| 24451123 | Background |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C004691 | colistinmethanesulfonic acid |
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Bacterial genomic DNA will be extracted and purified from sputum samples and sequenced by 454 pyrosequencing.
| Colistimethate 75 mg inhaled two times daily | Drug |
|
| 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. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |