NCT00954018

Brief Summary

Scientist have begun to realize that many types of bacteria often live together as a complex community, and the investigators wish to apply that idea to the bacteria in the respiratory system of people with Cystic Fibrosis (CF). It is possible that the survival of the many millions of bacteria in the CF lung depends on the production of special chemicals that might be made only by very few types of bacteria. If that is true, medicines that interfere with those chemicals could treat the lung infections that cause trouble for nearly all people with CF. The investigators wish to study the production of several potentially critical chemicals by the respiratory bacteria and to examine the effect of those chemicals on the makeup of the entire community of bacteria. To detect all the bacteria in that community, the investigators will use new methods that use bacterial genetic information and can detect hundreds of different types of bacteria in respiratory samples of individual CF patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2017

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

8.3 years

First QC Date

August 5, 2009

Last Update Submit

February 13, 2023

Conditions

Study Arms (3)

Cystic Fibrosis patient during outpatient clinic visit

Cystic Fibrosis patients during hospitalization

CF patients about to have sinus surgery and bronchoscopy

Eligibility Criteria

Age2 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cystic fibrosis patients will be contacted during clinical care visits and inpatient hospitalizations.

You may qualify if:

  • confirmed diagnosis of Cystic Fibrosis
  • to 55 years of age

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hosptital, Boston

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

throat swabs or sputum

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

August 1, 2009

Primary Completion

November 10, 2017

Study Completion

November 10, 2017

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations