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

• Status: Terminated
• Trial end date: 2020-01-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Tobramycin

Criteria

Inclusion Criteria:

• Patient with cystic fibrosis confirmed by sweat or genetic test

• Patient with clinical signs of exacerbation (increased cough, sputum (abundance, purulence), fever, anorexia, weight loss and FEV1) or acute exacerbations (defined at the clinician's discretion )

• FEV1 ≥ 25%

• Pseudomonas aeruginosa chronic carriers (defined by at least two antipyocyanic precipitation arcs or at least 3 successive positive ECBCs over a period of 18 months)

• Patient who received at least 1 IV course of antibiotics in the 18 months prior to inclusion.

Exclusion Criteria:

• Severe exacerbation (requiring hospitalization due to severe amputation of FEV 1, oxygen deficiency, or severe impairment of general health).

• Patient with 3rd antibiotic therapy (triple therapy)

• Patient colonized in Burkholderia cepacia

• Patient colonized by an atypical mycobacterium

• Patient with pulmonary transplant or transplant

• chronic tinnitus

• patient using hearing aid

• Hypersensitivity to tobramycin and other antibiotics of the aminoglycoside family

• Cirrhosis of Grades B and C according to the Child-Pugh Classification

• Myasthenia gravis

• Simultaneous administration of another aminoglycoside

• Renal failure

• Recent history of severe hemoptysis (within 2 months before inclusion)

• Patient participating simultaneously in another clinical study conducted on a drug for the duration of its participation in this research