Cystic FibrosisPhase 3TOBRAMUCNCT03066453
Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis
A Phase 3 study testing Tobi Inhalant Product and Nebcin in people with Cystic Fibrosis, run by University Hospital, Lille at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Tobi Inhalant Product and Nebcin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 7 sitesFrance
- Study dates
- 13 Jun 2017to 16 Jan 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CRCM pédiatrique - CHU d'Amiens Hôpital Nord
Amiens
CRCM mixte - CHU de Caen Hôpital Côte de Nacre
Caen
CRCM mixte - CH de Dunkerque
Dunkirk
CRCM mixte - CH de Lens
Lens
CRCM adulte - CHRU de Lille Hôpital Calmette
Lille
CRCM pédiatrique - CHRU de Lille Hôpital Jeanne de Flandres
Lille
CRCM mixte - CHU de Rouen Hôpital Charles Nicolle
Rouen
About this study
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.
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Tobi Inhalant Product, Nebcin
- Keywords
- cystic fibrosis, tobramycin, antibiotic courses, FEV1
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobi Inhalant ProductDrug
inhaled tobramycin 300 mg twice per day
NebcinDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Standard cure | Experimental | Antibiotic IV (Nebcin) 14 days and 14 days of tobramycin IV associated with one or more other antibiotic (s) IV in routine care Receives: Drug: Tobi Inhalant Product; Drug: Nebcin |
| Short cure | Experimental | 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 Receives: Drug: Tobi Inhalant Product; Drug: Nebcin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume at one second (FEV1) by spirometry
measure of dyspnea
Measured: 18 months of the cure
Secondary outcomes (6)
Forced expiratory volume at one second (FEV1) by spirometry
measure of dyspnea
Measured: baseline and between day 16 or day 22
Visual Analog Scale
measure of dyspnea, condition of patient, bronchial congestion
Measured: baseline and between day 16 or day 22
number of participants with Bronchial congestion
Measured: baseline and between day 16 or day 22
Sputum sample culture
a descriptive analysis of Pseudomonas aeruginosa, and the other bacteria in the bacterial flora of sputum
Measured: baseline and between day 16 or day 22
Occurrence of the first exacerbation after the cure
Measured: during 18 months
Number of pulmonary exacerbations and those leading to hospitalization
Measured: during 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start13 Jun 2017
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Why it stopped: new treatment that changes the management of the disease
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Prévotat, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066453
- Sponsor's protocol ID
- 2014_21
- Other IDs
- 2014-003882-10, PHRC I 2013, 2014
- Acronym
- TOBRAMUC
- Status last verified
- Aug 2021
- First submitted
- 23 Feb 2017
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03066453
- Acronym / sponsor ID
- TOBRAMUC / 2014_21
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, tobramycin, antibiotic courses, FEV1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: new treatment that changes the management of the disease
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard cure | Experimental | Drug: Tobi Inhalant Product, Drug: NebcinAntibiotic IV (Nebcin) 14 days and 14 days of tobramycin IV associated with one or more other antibiotic (s) IV in routine care |
| Short cure | Experimental | Drug: Tobi Inhalant Product, Drug: Nebcinantibiotic 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 |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobi Inhalant Productinhaled tobramycin 300 mg twice per day | Drug | Short cure, Standard cure |
| Nebcin10 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) | Drug | Short cure, Standard cure |
Primary outcome
Forced expiratory volume at one second (FEV1) by spirometry
Time frame: 18 months of the cure
measure of dyspnea
6 secondary outcomes
Forced expiratory volume at one second (FEV1) by spirometry
Time frame: baseline and between day 16 or day 22
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
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
Results and safety
The study was stopped early (reason given: new treatment that changes the management of the disease). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Prévotat, MD principal investigator
University Hospital, Lille
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tobi Inhalant Product and Nebcin in people with Cystic Fibrosis, run by University Hospital, Lille at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: new treatment that changes the management of the disease). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume at one second (FEV1) by spirometry (time frame: 18 months of the cure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.