Cystic FibrosisCFMATTERSNCT02526004
Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified
A study testing Ceftazidime and Tobramycin in people with Cystic Fibrosis, run by University College Cork at 1 site in Ireland.
Trial summary
Antimicrobial resistance is a significant challenge facing global healthcare. The unnecessary use of antibiotics is a key driver in the development of antibiotic resistance. Cystic Fibrosis (CF) represents a unique disease model to study bacterial resistance and to explore therapeutic strategies for same, as chronic… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Ceftazidime and Tobramycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2013to 30 Jun 2018
- Phase
- Interventional
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written and informed consent, and assent where required.
- Age 16 years or older at enrolment
- Diagnosis of CF by standard sweat test and/or genetic analysis
- Persistent pulmonary Pseudomonas aeruginosa colonization confirmed on at least 2 occasions in the preceding 12 months
- Screening FEV1 predicted of >25%
- Able to perform spirometry reproducibly prior to enrolment
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- Able to expectorate and provide a sputum sample at least once daily
- ≥1 non-elective course of intravenous antibiotics in the preceding year
- Able to understand and comply with protocol requirements, restrictions and instructions and likely to complete the study as planned, as judged by the investigator
Who cannot join
- Life expectancy less than 6 months
- They are a solid organ transplant recipient
- Have a requirement for immunosuppression ≥10mg corticosteroids per day
- Previous positive culture of non-tuberculosis mycobacteria species M.avium, M.abscessus or M.intracellulare within the last 12 months or undergoing active therapy
- Positive culture of any Burkholderia cepacia species within the last 12 months or undergoing active therapy
- Allergic bronchopulmonary aspergillosis on treatment
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- Known allergies to more than 3 different classes of antibiotics, and intolerance or allergy to tobramycin.
- Liver portal hypertension, determined by identification of oesophageal varices
- Advanced kidney disease requiring a dose reduction of ceftazidime or contraindicating aminoglycosides
- History of any illness that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
- If patient undergoes a pulmonary exacerbation before the Microbiome analysis is reviewed by the Consensus Treatment Panel and i.v. antibiotics are administered. In this case, a repeat sputum will be sent for analysis 4 weeks after end of antibiotic treatment.
- Pregnant or breast-feeding at time of eligible pulmonary exacerbation
Trial locations and contacts
1 site in 1 country.
About this study
Antimicrobial resistance is a significant challenge facing global healthcare. The unnecessary use of antibiotics is a key driver in the development of antibiotic resistance. Cystic Fibrosis (CF) represents a unique disease model to study bacterial resistance and to explore therapeutic strategies for same, as chronic lung infection overlaps with acute lung exacerbation's caused by a multitude of organisms. With time, chronic polymicrobial infection develops, with the most dominant infecting organism being Pseudomonas aeruginosa. In acute CF infections, empiric intravenous antibiotics are usually given for two weeks. Recurrent infections and treatments result in increasing antimicrobial resistance, and alterations in pathogen host interactions in the lung and gut flora. Next-generation DNA sequencing technology now offers DNA-based personalised diagnostics and treatment strategies. Enhancing our knowledge of the microbiome allows the use of stratified targeted antibacterial therapy that can be compared with standard empirical antibacterial therapy currently used. Cystic Fibrosis Microbiome-determined Antimicrobial Therapy Trial in Exacerbations: Results Stratified (CFMATTERS) will provide a randomized multi-centre controlled trial of microbiome-derived antimicrobial treatments versus current empirical therapy.
- Conditions
- Cystic Fibrosis
- Being tested
- Ceftazidime, Tobramycin
- Keywords
- Cystic Fibrosis, Microbiome, Stratified Antibacterial therapy, Resistance, Pathogen Host Interaction
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftazidimeDrug
TobramycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard Empiric Treatment | Active comparator | Ceftazidime or Aztreonam (in case of Ceftazidime allergy) and Tobramycin Receives: Drug: Ceftazidime; Drug: Tobramycin |
| Microbiome Guided Treatment | Experimental | Ceftazidime or Aztreonam (in case of Ceftazidime allergy) and Tobramycin and 3rd Antibiotic based on the Microbiome analysis Receives: Drug: Ceftazidime; Drug: Tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change in recovery (post-exacerbation) FEV1 relative to the previous pre-exacerbation FEV1.
Measured: Time from enrollment to 14 days post initiation of IV antibiotics for elligible exacerbation.
Secondary outcomes (6)
The time to next pulmonary exacerbation
Measured: Time from pulmonary exacerbation day 0, to next pulmonary exacerbation up to study close month 21
The improvement in symptom burden by day 7 as determined by Cystic Fibrosis Respiratory Symptom Diary (CFRSD)
As determined by Cystic Fibrosis Respiratory Symptom Diary (CFRSD)
Measured: Time from pulmonary exacerbation day 0 to day 7 of pulmonary exacerbation
The improvement in health related quality of life at day 28 post treatment and at 3 months as determined by the Cystic Fibrosis Questionnaire Revised (CFQR)
As determined by the Cystic Fibrosis Questionnaire Revised (CFQR)
Measured: Time from pulmonary exacerbation day 0 to day 28 and month 3 post study treatment
Total number of i.v. antibiotic days (home or in hospital) from time of randomisation in the trial
Measured: Time from enrollment in the study up to study close month 21
Change in FEV1
Measured: Time from enrollment in the study up to study close month 21
Total number of exacerbations post trial treatment
Measured: Time from pulmonary exacerbation day 0 to study close month 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start1 Oct 2013
- Primary completion30 Jun 2017
- Study completion30 Jun 2018
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Belfast, University of Paris 5 - Rene Descartes, University of Dundee, University of Washington, University Hospital Heidelberg, Teagasc, Clininfo S.A., GABO:mi, Papworth Hospital NHS Foundation Trust, KU Leuven, Assistance Publique - Hôpitaux de Paris, European Union
- Responsible party
- Principal investigator, Barry Plant, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526004
- Sponsor's protocol ID
- UCC-CFMATTERS
- Acronym
- CFMATTERS
- Status last verified
- Apr 2025
- First submitted
- 10 Aug 2015
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified
- ClinicalTrials.gov ID
- NCT02526004
- Acronym / sponsor ID
- CFMATTERS / UCC-CFMATTERS
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Microbiome, Stratified Antibacterial therapy, Resistance, Pathogen Host Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Queen's University, Belfast, University of Paris 5 - Rene Descartes, University of Dundee, University of Washington, University Hospital Heidelberg, Teagasc, Clininfo S.A., GABO:mi, Papworth Hospital NHS Foundation Trust, KU Leuven, Assistance Publique - Hôpitaux de Paris, European Union
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 18 Aug 2015 (estimated)
- 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.
Antimicrobial resistance is a significant challenge facing global healthcare. The unnecessary use of antibiotics is a key driver in the development of antibiotic resistance. Cystic Fibrosis (CF) represents a unique disease model to study bacterial resistance and to explore therapeutic strategies for same, as chronic lung infection overlaps with acute lung exacerbation's caused by a multitude of organisms. With time, chronic polymicrobial infection develops, with the most dominant infecting organism being Pseudomonas aeruginosa. In acute CF infections, empiric intravenous antibiotics are usually given for two weeks. Recurrent infections and treatments result in increasing antimicrobial resistance, and alterations in pathogen host interactions in the lung and gut flora. Next-generation DNA sequencing technology now offers DNA-based personalised diagnostics and treatment strategies. Enhancing our knowledge of the microbiome allows the use of stratified targeted antibacterial therapy that can be compared with standard empirical antibacterial therapy currently used. Cystic Fibrosis Microbiome-determined Antimicrobial Therapy Trial in Exacerbations: Results Stratified (CFMATTERS) will provide a randomized multi-centre controlled trial of microbiome-derived antimicrobial treatments versus current empirical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Empiric Treatment | Active comparator | Drug: Ceftazidime, Drug: TobramycinCeftazidime or Aztreonam (in case of Ceftazidime allergy) and Tobramycin |
| Microbiome Guided Treatment | Experimental | Drug: Ceftazidime, Drug: TobramycinCeftazidime or Aztreonam (in case of Ceftazidime allergy) and Tobramycin and 3rd Antibiotic based on the Microbiome analysis |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Written and informed consent, and assent where required.
- Age 16 years or older at enrolment
- Diagnosis of CF by standard sweat test and/or genetic analysis
- Persistent pulmonary Pseudomonas aeruginosa colonization confirmed on at least 2 occasions in the preceding 12 months
- Screening FEV1 predicted of >25%
Key exclusion criteria (12 listed)
- Life expectancy less than 6 months
- They are a solid organ transplant recipient
- Have a requirement for immunosuppression ≥10mg corticosteroids per day
- Previous positive culture of non-tuberculosis mycobacteria species M.avium, M.abscessus or M.intracellulare within the last 12 months or undergoing active therapy
- Positive culture of any Burkholderia cepacia species within the last 12 months or undergoing active therapy
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 |
|---|---|---|
| Ceftazidime | Drug | Microbiome Guided Treatment, Standard Empiric Treatment |
| Tobramycin | Drug | Microbiome Guided Treatment, Standard Empiric Treatment |
Primary outcome
The percentage change in recovery (post-exacerbation) FEV1 relative to the previous pre-exacerbation FEV1.
Time frame: Time from enrollment to 14 days post initiation of IV antibiotics for elligible exacerbation.
6 secondary outcomes
The time to next pulmonary exacerbation
Time frame: Time from pulmonary exacerbation day 0, to next pulmonary exacerbation up to study close month 21
The improvement in symptom burden by day 7 as determined by Cystic Fibrosis Respiratory Symptom Diary (CFRSD)
Time frame: Time from pulmonary exacerbation day 0 to day 7 of pulmonary exacerbation
The improvement in health related quality of life at day 28 post treatment and at 3 months as determined by the Cystic Fibrosis Questionnaire Revised (CFQR)
Time frame: Time from pulmonary exacerbation day 0 to day 28 and month 3 post study treatment
Total number of i.v. antibiotic days (home or in hospital) from time of randomisation in the trial
Time frame: Time from enrollment in the study up to study close month 21
Change in FEV1
Time frame: Time from enrollment in the study up to study close month 21
Total number of exacerbations post trial treatment
Time frame: Time from pulmonary exacerbation day 0 to study close month 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceftazidime and Tobramycin in people with Cystic Fibrosis, run by University College Cork at 1 site in Ireland.
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 9 inclusion and 12 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: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The percentage change in recovery (post-exacerbation) FEV1 relative to the previous pre-exacerbation FEV1. (time frame: Time from enrollment to 14 days post initiation of IV antibiotics for elligible exacerbation.). 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 10 Apr 2025.