Antibiotic treatment for nontuberculous mycobacteria lung infection in people with cystic fibrosis
Referencias
References to studies awaiting assessment
NCT01315236. Arikace® for Nontuberculous Mycobacteria. www.clinicaltrials.gov/ct2/show/NCT01315236?term=arikace&rank=4 (accessed 01 October 2012). [ClinicalTrials.gov identifier: NCT01315236]
Olivier KN, Eagle G, McGinnis II JP, Micioni L, Daley CL, Winthrop KL, et al. Randomized, double‐blind, placebo‐controlled, open‐label study of liposomal amikacin for inhalation (LAI) in patients with recalcitrant nontuberculous mycobacterial lung disease (NTM‐LD) [abstract]. Pediatric Pulmonology 2014;49 Suppl 38:321, Abstract no: 293. [CENTRAL: 1012528; CFGD Register: PI281; CRS: 5500131000000183]
Additional references
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References to other published versions of this review
Waters V, Ratjen F. Antibiotic treatment for nontuberculous mycobacteria lung infection in people with cystic fibrosis. Cochrane Database of Systematic Reviews 12, Issue 7. [DOI: 10.1002/14651858.CD010004]
Waters V, Ratjen F. Antibiotic treatment for nontuberculous mycobacteria lung infection in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2012, Issue 12. [DOI: 10.1002/14651858.CD010004.pub2]
Characteristics of studies
Characteristics of studies awaiting assessment [ordered by study ID]
| Methods | Randomized (1:1), double‐blind, placebo‐controlled trial. |
| Participants | Adults (both with CF and without CF) with recalcitrant non‐tuberculous mycobacterial lung disease on a stable multi‐drug regimen. Eligible age range 18 to 75 years. Estimated number to recruit: 100. |
| Interventions | Liposomal amikacin (Arikace®, 560 mg) for inhalation once daily using the PARI Investigational eFlow® Nebulizer (administration time approximately 13 minutes) or placebo (administration procedures, volume and administration time is the same as for Arikace®). Randomized treatment period planned for 84 days (Arikace® and placebo) with an option for 84 additional days of dosing with Arikace® in the open label extension. |
| Outcomes | Primary outcome
Secondary outcomes
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| Notes | PI confirmed inclusion of participants with CF. Supported by Insmed Incorporated. |
