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

Phase 3

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standard cure	Tobi Inhalant Product	Antibiotic IV (Nebcin) 14 days and 14 days of tobramycin IV associated with one or more other antibiotic (s) IV in routine care
Short cure	Tobi Inhalant Product	antibiotic IV (Nebcin)14 days but with only 5 days of tobramycin IV followed 9 days of inhaled tobramycin (Tobi Inhalant Product) associated with one or more other antibiotic (s) IV in routine care
Standard cure	Nebcin	Antibiotic IV (Nebcin) 14 days and 14 days of tobramycin IV associated with one or more other antibiotic (s) IV in routine care
Short cure	Nebcin	antibiotic IV (Nebcin)14 days but with only 5 days of tobramycin IV followed 9 days of inhaled tobramycin (Tobi Inhalant Product) associated with one or more other antibiotic (s) IV in routine care

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume at one second (FEV1) by spirometry	18 months of the cure	measure of dyspnea

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale	baseline and between day 16 or day 22	measure of dyspnea, condition of patient, bronchial congestion
Number of pulmonary exacerbations and those leading to hospitalization	during 18 months
number of participants with Bronchial congestion	baseline and between day 16 or day 22
Occurrence of the first exacerbation after the cure	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
Forced expiratory volume at one second (FEV1) by spirometry	baseline and between day 16 or day 22	measure of dyspnea

Locations (7): CRCM mixte - CH de Dunkerque
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Dunkerque, France
CRCM mixte - CHU de Caen Hôpital Côte de Nacre
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Caen, France
CRCM pédiatrique - CHU d'Amiens Hôpital Nord
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Amiens, France
CRCM mixte - CH de Lens
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Lens, France
CRCM adulte - CHRU de Lille Hôpital Calmette
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Lille, France
CRCM pédiatrique - CHRU de Lille Hôpital Jeanne de Flandres
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Lille, France
CRCM mixte - CHU de Rouen Hôpital Charles Nicolle
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Rouen, France