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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
inhaled tobramycin 300 mg twice per day
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)
CRCM pédiatrique - CHU d'Amiens Hôpital Nord
Amiens, France
CRCM mixte - CHU de Caen Hôpital Côte de Nacre
Caen, France
CRCM mixte - CH de Dunkerque
Dunkirk, France
CRCM mixte - CH de Lens
Lens, France
Forced expiratory volume at one second (FEV1) by spirometry
measure of dyspnea
Time frame: 18 months of the cure
Forced expiratory volume at one second (FEV1) by spirometry
measure of dyspnea
Time frame: baseline and between day 16 or day 22
Visual Analog Scale
measure of dyspnea, condition of patient, bronchial congestion
Time frame: baseline and between day 16 or day 22
number of participants with Bronchial congestion
Time frame: baseline and between day 16 or day 22
Sputum sample culture
a descriptive analysis of Pseudomonas aeruginosa, and the other bacteria in the bacterial flora of sputum
Time frame: baseline and between day 16 or day 22
Occurrence of the first exacerbation after the cure
Time frame: during 18 months
Number of pulmonary exacerbations and those leading to hospitalization
Time frame: during 18 months
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CRCM adulte - CHRU de Lille Hôpital Calmette
Lille, France
CRCM pédiatrique - CHRU de Lille Hôpital Jeanne de Flandres
Lille, France
CRCM mixte - CHU de Rouen Hôpital Charles Nicolle
Rouen, France