Antimicrobial Resistance in Cystic Fibrosis (CF)
Antimicrobial Resistance in Sputum Obtained From Patients With Cystic Fibrosis (CF)
1 other identifier
observational
304
1 country
1
Brief Summary
People with cystic fibrosis (CF) often develop chronic pulmonary infections which are caused by a variety of organisms, the most predominant being Pseudomonas aeruginosa. Antibiotics are important in managing CF lung infections. Antibiotic use in CF was altered about ten years ago with the approval of inhaled tobramycin, an aminoglycoside which is effective in treating P. aeruginosa. A decade later, CF clinicians are increasingly concerned about the likelihood of induction of aminoglycoside-resistance with prolonged use of inhaled tobramycin to treat chronic P. aeruginosa airway infections. The goal of this study is to examine the current microbiology and susceptibility of organisms from CF sputum, correlate it with antibiotic use, and compare it with previous data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2006
Typical duration for all trials
1 active site
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
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 2, 2006
CompletedFirst Posted
Study publicly available on registry
August 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFebruary 10, 2009
February 1, 2009
August 2, 2006
February 6, 2009
Conditions
Keywords
Eligibility Criteria
Children and young adults with cystic fibrosis
You may qualify if:
- \> 6 years of age.
- Documented sweat chloride greater than 60 mEq/mL by quantitative pilocarpine iontophoresis test or homozygous for deltaF508 genetic mutation (or heterozygous for two well-characterized mutations) and one or more clinical features consistent with CF.
- Most recent FEV1 between 25% and 75% predicted when clinically stable; must be obtained at or within 3 months prior to study visit.
- P. aeruginosa present in the most recent sputum or throat culture obtained within 6 months prior to study visit.
- Able to expectorate sputum on a routine basis.
- Written informed consent provided.
You may not qualify if:
- Administration of any anti-pseudomonal antibiotics by any route within 14 days prior to study visit.
- Participation in a research protocol that potentially involves antibiotic treatment within 14 days prior to study visit.
- Requiring treatment with intravenous or inhaled anti-pseudomonal antibiotics at study visit.
- B. cepacia complex present in the most recent sputum or throat culture obtained within 6 months prior to study visit.
- Post lung transplantation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seattle Children's Hospitallead
- Cystic Fibrosis Foundationcollaborator
Study Sites (1)
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105, United States
Related Publications (1)
Burns JL, Emerson J, Stapp JR, Yim DL, Krzewinski J, Louden L, Ramsey BW, Clausen CR. Microbiology of sputum from patients at cystic fibrosis centers in the United States. Clin Infect Dis. 1998 Jul;27(1):158-63. doi: 10.1086/514631.
PMID: 9675470BACKGROUND
Biospecimen
Bacterial isolates
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jane L Burns, MD
University of Washington and Children's Hospital and Regional Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 2, 2006
First Posted
August 4, 2006
Study Start
March 1, 2006
Study Completion
June 1, 2008
Last Updated
February 10, 2009
Record last verified: 2009-02