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

NCT02526004 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2025-04-10

No results posted yet for this study

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 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

Interventions

DRUG

Ceftazidime

DRUG

Tobramycin

Sponsors & Collaborators

  • Queen's University, Belfast

    collaborator OTHER
  • University of Paris 5 - Rene Descartes

    collaborator OTHER
  • University of Dundee

    collaborator OTHER
  • University of Washington

    collaborator OTHER
  • University Hospital Heidelberg

    collaborator OTHER
  • Teagasc

    collaborator INDUSTRY
  • Clininfo S.A.

    collaborator INDUSTRY
  • GABO:mi

    collaborator INDUSTRY
  • Papworth Hospital NHS Foundation Trust

    collaborator OTHER_GOV
  • KU Leuven

    collaborator OTHER
  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER
  • European Union

    collaborator OTHER
  • University College Cork

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-01
Primary Completion
2017-06-30
Completion
2018-06-30

Countries

  • Ireland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526004 on ClinicalTrials.gov