Assessment of microbiological efficacy and tolerability of inhaled tobramycin vs placebo in cystic fibrosis patients, primo colonised by Pseudomonas aeruginosa justified inhaled antiobiotherapeutical treatment during 28 days.
Conditions
Interventions
Product Code: NEB/01-07
Pharmaceutical Form: Inhalation vapour, solution
Pharmaceutical form of the placebo: Inhalation vapour, liquid
Sponsors
Laboratoire Erempharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients aged > 12 months, with cystic fibrosis (genetical study or TdS > 60 meq/l). - primo colonization by Pseudomonas aeruginosa and receiving antibiotic treatment according consensus conference. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - inhaled antibiotic treatment during previous 28 days before study - Concommittent traitement or during previous 28 days of folowwing antiobiotic: Ticarcilline, Ticarcilline + clavulanic Acid, Piperacilline, Piperacilline + Tazobactam, Ceftazidime, Cefepime, Meropeneme, Aztreonam, Colistine, Rifampicine, Cefotaxime, Imipeneme, Gentamicine, Tobramycine, Amikacine, Norfloxacine, Ciprofloxacine, Fosfomycine - chronical or occasional colonisation by Pseudomonas aeruginosa - intolerability, toxicity or hypersensitivity to inhaled tobramycin - renal failure, hypoacusis - VEMS = 30% - acute exacerbation needing immediate parenteral antibiotic treatment (primo infection), pregnancy, feeding, against indications in the treatment or medical xplorations - hypersensibility to an aminoside
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess bactericidal efficacy on Pseudomonas aeruginosa of inhaled Tobramycin Erempharma® administered for 28 days : 300 mg per day (2 inhalations of 150 mg each) by Aeroneb. ;Secondary Objective: - To assess inhibitor ratio of inhaled tobramycin on P. aeruginosa in patients (C/CMI) and modifications during treatment - To assess safety of inhaled tobramycin - Evaluer l’impact des aérosols sur la flore bactérienne de l’expectoration - To assess microbiological impact on staphylococcus aureus in cas of associated colonization - To assess the improvement of P. aeruginosa bacterial charge during follow-up ;Primary end point(s): Mesurement of Pseudomonas aeruginosa rate in bronchial secretions (eradication or decrease more than 2 log10 will be considered as significant for the patient). | — |
Countries
France
Outcome results
None listed