A Study to Investigate Cystic Fibrosis Pulmonary Exacerbations and the Lung Microbiome

NCT05088447 | Terminated

• 1 other identifier: 32509
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The present application proposes to study the role the composition of the pediatric CF airway microbiota plays in frequent pulmonary exacerbations in pediatric CF patients. In order to accomplish this goal the dynamics of the composition of the CF airway microbiota in two distinct subsets of pediatric patients with CF will be characterized, those with frequent pulmonary exacerbations and clinically stable children. Clinical measures of pulmonary function, patient reported symptoms, sleep quality, and antibiotic usage will be recorded, and these findings will be correlated with the lung microbiota data. This strategy promises to identify the key characteristics of the pediatric CF microbiota, which can in turn be used as noninvasive markers to identify those patients at a higher risk for experiencing repeated pulmonary exacerbations.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in lung microbiome profile

  Lung microbiome in Cystic Fibrosis pulmonary exacerbations

  Baseline - 3 years

Study Arms (2)

Stable Disease

15 control "stable disease" participants

Frequent Exacerbation Cohort

15 experimental "frequent exacerbation cohort"

Eligibility Criteria

• Age: Up to 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

For the "Pulmonary Exacerbation Cohort," recruitment will be of cystic fibrosis pediatric patients with 3 or more hospital admissions with an admitting diagnosis of pulmonary exacerbation, requiring IV antibiotics, within the 12 month period prior to study enrollment, irrespective of race or ethnicity. This cohort will be matched with a "Clinically Stable Disease Cohort" which is matched by age, gender and CF genotype, irrespective of race or ethnicity. Ages recruited will be children, adolescents and young adults with Cystic Fibrosis from age 0-22 years.

You may qualify if:

• Diagnosis of CF (: a. One or more clinical features of CF AND (b or c); b. Sweat chloride \> 60 mEq/L; c. Two known CF mutations)
• or more admissions with an admitting diagnosis of pulmonary exacerbation, requiring IV antibiotics, within the 12 month period prior to study enrollment.
• Clinically Stable Disease Cohort
• Diagnosis of CF (: a. One or more clinical features of CF AND (b or c); b. Sweat chloride \> 60 mEq/L; c. Two known CF mutations)
• Age and gender matched to Pulmonary Exacerbation Cohort
• No hospitalizations with an admitting diagnosis of pulmonary exacerbation, within the 12 month period prior to study enrollment.

You may not qualify if:

• History of intolerance or inability to tolerate the induced sputum protocol.
• History of organ transplantation.
• Any patient that in discretion of the investigators is not suitable.
• Any clinically unstable participants.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Cystic Fibrosis Clinic, LPCH

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Michael Tracy, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: October 22, 2021
• Study Start: February 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

US (1)