Cystic FibrosisNCT00360503
Antimicrobial Resistance in Cystic Fibrosis (CF)
An observational study of Cystic Fibrosis, run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children and young adults with cystic fibrosis
Who may be able to join
- > 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
About this study
Official title: Antimicrobial Resistance in Sputum Obtained From Patients With Cystic Fibrosis (CF)
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.
Read the detailed description
Aminoglycosides are one of the mainstays of antibiotic therapy in CF. They are administered parenterally in synergistic combinations with β-lactam antibiotics for acute exacerbations and used by inhalation as single agents for chronic maintenance therapy. It is well known in CF and other chronic infections that chronic use of antibiotics results in resistance. Thus, the increasing use of aminoglycosides could have dramatically changed the microbiological epidemiology of CF, since it was last examined a decade ago. It will be important to determine the current prevalence of antibiotic resistance in CF pathogens. Current antimicrobial strategies may also be contributing to the increased rate of isolation of novel and difficult to treat organisms, including intrinsically antibiotic-resistant bacteria. These issues are important both for CF clinicians and for researchers developing new antimicrobials to be used in CF.
To determine if the prevalence of P. aeruginosa resistance and the prevalence of other CF pathogens has changed over the past ten years, this multi-center cross-sectional study will enroll a contemporary cohort of patients with CF and will compare their sputum microbiology and susceptibility data with corresponding baseline data from an historical cohort consisting of patients enrolled in the prior phase 3 trials of inhaled tobramycin, conducted by PathoGenesis Corporation. (A Phase III Placebo Controlled Clinical Trial (PC-TNDS-002) to Study the Safety and Efficacy of Tobramycin in Inhalation in Patients with Cystic Fibrosis). The data set from the phase 3 trials which will be used for this research project will be anonymous.
This current study will be coordinated by the CF research team at CHRMC and aims to enroll 520 patients at approximately 50 participating sites across the United States. The contemporary cohort will include patients with CF who are ages 6 years and older and able to expectorate sputum. Patients will be enrolled from many of the same CF centers that participated in the phase 3 trials of inhaled tobramycin, and eligibility criteria will be similar to those used in the phase 3 trials. Subjects enrolled in the contemporary cohort will have a single study visit to obtain a sputum sample that will be sent to a central laboratory for culture and susceptibility testing.
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Antibiotic resistance, Microbiology
- Medical subject headings
- Cystic Fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startMar 2006
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Investigators
- Jane L Burns, MD, Principal investigator, University of Washington and Children's Hospital and Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360503
- Sponsor's protocol ID
- BURNS04A0
- Status last verified
- Feb 2009
- First submitted
- 2 Aug 2006
- Last updated
- 10 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9675470
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Resistance in Sputum Obtained From Patients With Cystic Fibrosis (CF)
- ClinicalTrials.gov ID
- NCT00360503
- Acronym / sponsor ID
- BURNS04A0
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Antibiotic resistance, Microbiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Mar 2006
- Study completion
- Jun 2008 (actual)
- First posted
- 4 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aminoglycosides are one of the mainstays of antibiotic therapy in CF. They are administered parenterally in synergistic combinations with β-lactam antibiotics for acute exacerbations and used by inhalation as single agents for chronic maintenance therapy. It is well known in CF and other chronic infections that chronic use of antibiotics results in resistance. Thus, the increasing use of aminoglycosides could have dramatically changed the microbiological epidemiology of CF, since it was last examined a decade ago. It will be important to determine the current prevalence of antibiotic resistance in CF pathogens. Current antimicrobial strategies may also be contributing to the increased rate of isolation of novel and difficult to treat organisms, including intrinsically antibiotic-resistant bacteria. These issues are important both for CF clinicians and for researchers developing new antimicrobials to be used in CF.
To determine if the prevalence of P. aeruginosa resistance and the prevalence of other CF pathogens has changed over the past ten years, this multi-center cross-sectional study will enroll a contemporary cohort of patients with CF and will compare their sputum microbiology and susceptibility data with corresponding baseline data from an historical cohort consisting of patients enrolled in the prior phase 3 trials of inhaled tobramycin, conducted by PathoGenesis Corporation. (A Phase III Placebo Controlled Clinical Trial (PC-TNDS-002) to Study the Safety and Efficacy of Tobramycin in Inhalation in Patients with Cystic Fibrosis). The data set from the phase 3 trials which will be used for this research project will be anonymous.
This current study will be coordinated by the CF research team at CHRMC and aims to enroll 520 patients at approximately 50 participating sites across the United States. The contemporary cohort will include patients with CF who are ages 6 years and older and able to expectorate sputum. Patients will be enrolled from many of the same CF centers that participated in the phase 3 trials of inhaled tobramycin, and eligibility criteria will be similar to those used in the phase 3 trials. Subjects enrolled in the contemporary cohort will have a single study visit to obtain a sputum sample that will be sent to a central laboratory for culture and susceptibility testing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and young adults with cystic fibrosis
Key inclusion criteria (6 listed)
- > 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2009.
- Background: PubMed 9675470Burns 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane L Burns, MD principal investigator
University of Washington and Children's Hospital and Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00360503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2009.