drugset / Trial / NCT03066453

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

NCT03066453

Phase 3 Terminated 23 enrolled University Hospital, Lille
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2017-06-13
Primary completion
2020-01-16
Completion
2020-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Tobramycin Small molecule 10 mg/kg Inhaled
Subject Tobramycin Small molecule 12 mg/kg Inhaled
Subject Tobramycin Small molecule 15 mg/kg Inhaled
Subject Tobramycin Small molecule 300 mg Inhaled

Indications