Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2022
• Main ID: NCT02526004
• Date of registration: 10/08/2015
• Prospective Registration: No
• Primary sponsor: University College Cork
• Public title: Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified CFMATTERS
• Scientific title: Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified
• Date of first enrolment: October 1, 2013
• Target sample size: 223
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02526004
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment.
• Phase: N/A

Countries of recruitment

Ireland

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

- 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



Age minimum: 16 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Ceftazidime

Drug: Tobramycin

Primary Outcome(s)

The percentage change in recovery (post-exacerbation) FEV1 relative to the previous pre-exacerbation FEV1. [Time Frame: Time from enrollment into the study up to study close month 21]

Secondary Outcome(s)

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]

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]

The time to next pulmonary exacerbation [Time Frame: Time from pulmonary exacerbation day 0, to next pulmonary exacerbation 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]

Change in FEV1 [Time Frame: Time from enrollment in the study up to study close month 21]

Secondary ID(s)

UCC-CFMATTERS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Assistance Publique - Hôpitaux de Paris

European Union

University of Dundee

KU Leuven

Queen's University, Belfast

Teagasc

University of Washington

University Hospital Heidelberg

University of Paris 5 - Rene Descartes

Clininfo S.A.

Papworth Hospital NHS Foundation Trust

GABO:mi