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

University Hospital, Lille

Status and phase: Terminated; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: Tobi Inhalant Product; Drug: Nebcin

Study type: Interventional

Funder types: Other

Identifiers

NCT03066453

PHRC I 2013 (Other Identifier)

2014_21

2014-003882-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Standard cure

Experimental group

Description:

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

Treatment:

Drug: Tobi Inhalant Product

Drug: Nebcin

Short cure

Experimental group

Description:

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

Treatment:

Drug: Tobi Inhalant Product

Drug: Nebcin