NCT01306279

Brief Summary

Given the treatment burden and excess morbidity and mortality associated with acute infective exacerbations in cystic fibrosis, a clear understanding of the mechanisms involved in the origins of an infective exacerbation and the response to antibiotics is vital to improving long-term outcomes in CF. This study will examine 3 areas of interest in CF exacerbations.

  1. 1.Bacterial biodiversity and its clinical significance
  2. 2.The role of bacteria which are able to rapidly mutate (hypermutators)
  3. 3.Inter-bacterial communication and its role in infective exacerbations

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

February 28, 2011

Last Update Submit

March 17, 2016

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisInfectionPulmonary exacerbationHypermutatorsBacterial diversityQuorum sensing

Study Arms (1)

Cystic Fibrosis, infection

Cystic Fibrosis patients with an infective exacerbation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with Cystic Fibrosis attending to commence intravenous antibiotics for a pulmonary exacerbation of CF

You may qualify if:

  • Confirmed diagnosis of Cystic Fibrosis
  • Chronic Pseudomonas aeruginosa
  • Symptoms and signs of infective exacerbation

You may not qualify if:

  • age under 16
  • unable to give consent or patients with significant mental health problems
  • co-existent active allergic bronchopulmonary aspergillosis requiring a change in steroid or antifungal therapy
  • a previous participant in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cystic Fibrosis, NHLI, Imperial College,

London, London, SW3 6NP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum

MeSH Terms

Conditions

Cystic FibrosisInfections

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Margaret Hodson, MD MSc FRCP

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 1, 2011

Study Start

February 1, 2011

Primary Completion

August 1, 2012

Last Updated

March 21, 2016

Record last verified: 2013-03

Locations

GB(1)