NCT03066453

Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis

Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the case of positive results, the reduction of the duration of IV treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Tobi Inhalant Product	inhaled tobramycin 300 mg twice per day
DRUG	Nebcin	10 to 12 mg/kg/day in 1 injection for adults and 10 to 15 mg/kg in 1 pediatric injection (combined with another IV antibiotic)

Timeline

• Start date: 2017-06-13
• Primary completion: 2020-01-16
• Completion: 2020-01-16
• First posted: 2017-02-28
• Last updated: 2021-09-05

Locations

7 sites across 1 country: France