Cystic Fibrosis
Conditions
Keywords
cystic fibrosis, tobramycin, antibiotic courses, FEV1
Brief 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.
Interventions
DRUGTobi Inhalant Product
inhaled tobramycin 300 mg twice per day
DRUGNebcin
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)
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced expiratory volume at one second (FEV1) by spirometry | 18 months of the cure | measure of dyspnea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | baseline and between day 16 or day 22 | measure of dyspnea, condition of patient, bronchial congestion |
| number of participants with Bronchial congestion | baseline and between day 16 or day 22 | — |
| Forced expiratory volume at one second (FEV1) by spirometry | baseline and between day 16 or day 22 | measure of dyspnea |
| Occurrence of the first exacerbation after the cure | during 18 months | — |
| Number of pulmonary exacerbations and those leading to hospitalization | during 18 months | — |
| Sputum sample culture | baseline and between day 16 or day 22 | a descriptive analysis of Pseudomonas aeruginosa, and the other bacteria in the bacterial flora of sputum |
Countries
France
Outcome results
None listed