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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 September 2021
• Main ID: NCT03066453
• Date of registration: 23/02/2017
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Lille
• Public title: Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis TOBRAMUC
• Scientific 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.
• Date of first enrolment: June 13, 2017
• Target sample size: 23
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03066453
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Anne Prévotat, MD
• Affiliation: University Hospital, Lille

Key inclusion & exclusion 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



Age minimum: 8 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Nebcin

Drug: Tobi Inhalant Product

Primary Outcome(s)

Forced expiratory volume at one second (FEV1) by spirometry [Time Frame: 18 months of the cure]

Secondary Outcome(s)

Forced expiratory volume at one second (FEV1) by spirometry [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]

Visual Analog Scale [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 [Time Frame: baseline and between day 16 or day 22]

Secondary ID(s)

PHRC I 2013

2014_21

2014-003882-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors