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

Cystic Fibrosis Clinical Trial

— TOBRAMUC  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03066453
• Other study ID #: 2014_21
• Secondary ID: 2014-003882-10PH
• Status: Terminated
• Phase: Phase 3
• Start date: June 13, 2017
• Est. completion date: January 16, 2020

Study information

• Verified date: August 2021
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Tobi Inhalant Product
inhaled tobramycin 300 mg twice per day
• 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)

Locations

Country	Name	City	State
France	CRCM pédiatrique - CHU d'Amiens Hôpital Nord	Amiens
France	CRCM mixte - CHU de Caen Hôpital Côte de Nacre	Caen
France	CRCM mixte - CH de Dunkerque	Dunkerque
France	CRCM mixte - CH de Lens	Lens
France	CRCM adulte - CHRU de Lille Hôpital Calmette	Lille
France	CRCM pédiatrique - CHRU de Lille Hôpital Jeanne de Flandres	Lille
France	CRCM mixte - CHU de Rouen Hôpital Charles Nicolle	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume at one second (FEV1) by spirometry	measure of dyspnea	18 months of the cure
Secondary	Forced expiratory volume at one second (FEV1) by spirometry	measure of dyspnea	baseline and between day 16 or day 22
Secondary	Visual Analog Scale	measure of dyspnea, condition of patient, bronchial congestion	baseline and between day 16 or day 22
Secondary	number of participants with Bronchial congestion		baseline and between day 16 or day 22
Secondary	Sputum sample culture	a descriptive analysis of Pseudomonas aeruginosa, and the other bacteria in the bacterial flora of sputum	baseline and between day 16 or day 22
Secondary	Occurrence of the first exacerbation after the cure		during 18 months
Secondary	Number of pulmonary exacerbations and those leading to hospitalization		during 18 months