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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-13

Study Completion Date

2020-01-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard cure

Antibiotic IV (Nebcin) 14 days and 14 days of tobramycin IV associated with one or more other antibiotic (s) IV in routine care

Group Type EXPERIMENTAL

Tobi Inhalant Product

Intervention Type DRUG

inhaled tobramycin 300 mg twice per day

Nebcin

Intervention Type DRUG

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)

Short cure

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

Group Type EXPERIMENTAL

Tobi Inhalant Product

Intervention Type DRUG

inhaled tobramycin 300 mg twice per day

Nebcin

Intervention Type DRUG

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)

Interventions

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Tobi Inhalant Product

inhaled tobramycin 300 mg twice per day

Intervention Type DRUG

Nebcin

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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No