Clinical trial NCT03066453: Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis
Official title: Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis, tobramycin, antibiotic courses, FEV1
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 23
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Forced expiratory volume at one second (FEV1) by spirometry
timeFrame: 18 months of the cure
Secondary outcomes:
measure: Forced expiratory volume at one second (FEV1) by spirometry
timeFrame: baseline and between day 16 or day 22
measure: Visual Analog Scale
timeFrame: baseline and between day 16 or day 22
measure: number of participants with Bronchial congestion
timeFrame: baseline and between day 16 or day 22
measure: Sputum sample culture
timeFrame: baseline and between day 16 or day 22
measure: Occurrence of the first exacerbation after the cure
timeFrame: during 18 months
measure: Number of pulmonary exacerbations and those leading to hospitalization
timeFrame: during 18 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CRCM pédiatrique - CHU d'Amiens Hôpital Nord
city: Caen
country: France
facility: CRCM mixte - CHU de Caen Hôpital Côte de Nacre
city: Dunkerque
country: France
facility: CRCM mixte - CH de Dunkerque
city: Lens
country: France
facility: CRCM mixte - CH de Lens
city: Lille
country: France
facility: CRCM adulte - CHRU de Lille Hôpital Calmette
city: Lille
country: France
facility: CRCM pédiatrique - CHRU de Lille Hôpital Jeanne de Flandres
city: Rouen
country: France
facility: CRCM mixte - CHU de Rouen Hôpital Charles Nicolle
Study officials:
affiliation: University Hospital, Lille
name: Anne Prévotat, MD
role: PRINCIPAL_INVESTIGATOR
References: