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

Primary Purpose

Cystic Fibrosis

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Tobi Inhalant Product
Nebcin
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, tobramycin, antibiotic courses, FEV1

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard cure

Short cure

Arm Description

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

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

Outcomes

Primary Outcome Measures

Forced expiratory volume at one second (FEV1) by spirometry
measure of dyspnea

Secondary Outcome Measures

Forced expiratory volume at one second (FEV1) by spirometry
measure of dyspnea
Visual Analog Scale
measure of dyspnea, condition of patient, bronchial congestion
number of participants with Bronchial congestion
Sputum sample culture
a descriptive analysis of Pseudomonas aeruginosa, and the other bacteria in the bacterial flora of sputum
Occurrence of the first exacerbation after the cure
Number of pulmonary exacerbations and those leading to hospitalization

Full Information

First Posted
February 23, 2017
Last Updated
August 30, 2021
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03066453
Brief Title
Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
new treatment that changes the management of the disease
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
January 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, tobramycin, antibiotic courses, FEV1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard cure
Arm Type
Experimental
Arm Description
Antibiotic IV (Nebcin) 14 days and 14 days of tobramycin IV associated with one or more other antibiotic (s) IV in routine care
Arm Title
Short cure
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Tobi Inhalant Product
Intervention Description
inhaled tobramycin 300 mg twice per day
Intervention Type
Drug
Intervention Name(s)
Nebcin
Intervention Description
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)
Primary Outcome Measure Information:
Title
Forced expiratory volume at one second (FEV1) by spirometry
Description
measure of dyspnea
Time Frame
18 months of the cure
Secondary Outcome Measure Information:
Title
Forced expiratory volume at one second (FEV1) by spirometry
Description
measure of dyspnea
Time Frame
baseline and between day 16 or day 22
Title
Visual Analog Scale
Description
measure of dyspnea, condition of patient, bronchial congestion
Time Frame
baseline and between day 16 or day 22
Title
number of participants with Bronchial congestion
Time Frame
baseline and between day 16 or day 22
Title
Sputum sample culture
Description
a descriptive analysis of Pseudomonas aeruginosa, and the other bacteria in the bacterial flora of sputum
Time Frame
baseline and between day 16 or day 22
Title
Occurrence of the first exacerbation after the cure
Time Frame
during 18 months
Title
Number of pulmonary exacerbations and those leading to hospitalization
Time Frame
during 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Prévotat, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRCM pédiatrique - CHU d'Amiens Hôpital Nord
City
Amiens
Country
France
Facility Name
CRCM mixte - CHU de Caen Hôpital Côte de Nacre
City
Caen
Country
France
Facility Name
CRCM mixte - CH de Dunkerque
City
Dunkerque
Country
France
Facility Name
CRCM mixte - CH de Lens
City
Lens
Country
France
Facility Name
CRCM adulte - CHRU de Lille Hôpital Calmette
City
Lille
Country
France
Facility Name
CRCM pédiatrique - CHRU de Lille Hôpital Jeanne de Flandres
City
Lille
Country
France
Facility Name
CRCM mixte - CHU de Rouen Hôpital Charles Nicolle
City
Rouen
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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