Cystic FibrosisNCT02363764
The Challenge of Obtaining Qualitative Bacterial Cultures in Non-expectorating Cystic Fibrosis Patients
An observational study of Cystic Fibrosis, run by Universitair Ziekenhuis Brussel.
Trial summary
Accurate identification of lower respiratory tract pathogens is standard of care in the management of CF patients and it is therefore recommended to perform regular bacterial cultures, at least once a year, but some even recommend monthly cultures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Nasal swab, Cough swab and Spontaneous expectorated sputum
- Type of treatment
- Surgery or procedure
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Oct 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CF patients
Who may be able to join
- Both expectorating and non-expectorating CF patients with confirmed diagnosis (sweat test / genotyping)
- All ages
- Attending the UZ Brussel CF Clinic
- Written informed consent from each participant and/or his parents or legal guardian
Who cannot join
- CF patients who underwent lung transplantation
- Denial of participation to the study
About this study
Accurate identification of lower respiratory tract pathogens is standard of care in the management of CF patients and it is therefore recommended to perform regular bacterial cultures, at least once a year, but some even recommend monthly cultures. This can be done through different methods, of which sputum and bronchoalveolar lavage (BAL) are the gold standard. However, BAL is an invasive method, not designated to repeat monthly. Therefore, the diagnosis of lower respiratory tract infections can be challenging in the non-expectorating CF patient. Other methods, such as induced sputum (IS), cough swabs and nasal swabs, have been developed to obtain bacterial cultures in these patients. Studies have investigated the reliability of these different sampling methods, however, with controversial conclusions.
Read the detailed description
- Protocol design:
The current protocol is designed to compare:
- Group 1: nasal swab, cough swab and spontaneous expectorated sputum in expectorating CF patients
- Group 2: nasal swab, cough swab and induced sputum in non-expectorating CF patients
- Group 3: nasal swab, cough swab, induced sputum and BAL in both expectorating and non-expectorating CF patients requiring clinically indicated bronchoscopy
II. Flow chart:
- Nasal swab obtained by the physiotherapyst (PT)
- Patient rinses his mouth with water, followed by autogenic drainage
- Cough swab obtained by the PT
- Obtainment of 3rd (4th) sample:
- Group 1: Sputum sample voluntary expectorated by the patient
- Group 2 and 3: Induced sputum sample --> voluntary coughed up and expectorated by the patient after inhalation of 4ml of HS OR
- Group 3: BAL -->obtained by the pulmonologist during bronchoscopy
- Filling out questionnaire on acceptability of the different sampling methods by patients >6 years of age (not in Group 3)
III. Analysis of the samples:
(Induced) Sputum samples, cough and nasal swabs are aseptically collected in the appropriate disposable and are immediately sent to the Laboratory for Microbiology and Infection Control of the Universitair Ziekenhuis Brussel, where analyses are carried out within 24h post-sampling.
These analyses include:
- Culture and identification of respiratory pathogens on selective and non-selective media
- Each type of colony will be identified by MALDI-TOF mass spectrometry, completed by other identification tests if needed
- When appropriate, susceptibility tests will be performed on the isolated bacteria
IV. Statistical analysis:
- Determination of sensitivity, specificity, positive predicted value, negative predicted value of the different sampling methods
- Preference for one method over another: crosstabs, Chi-square test
- Pain experienced with any method (Yes/No): Student's t-test
- VAS-scale pain per method: ANOVA
- Conditions
- Cystic Fibrosis
- Being tested
- Nasal swab, Cough swab, Spontaneous expectorated sputum, Induced sputum, Bronchoalveolar lavage
- Keywords
- respiratory sampling
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal swabProcedure or surgery
Will be obtained by the physiotherapist in:
- Expectorating CF patients
- Non-expectorating CF patients
- Bronchoscopy CF patients
Cough swabProcedure or surgery
Will be obtained by the physiotherapist in:
- Expectorating CF patients
- Non-expectorating CF patients
- Bronchoscopy CF patients
Spontaneous expectorated sputumProcedure or surgery
Will be obtained by the physiotherapist in:
- Expectorating CF patients
Induced sputumProcedure or surgery
Will be obtained by the physiotherapist in:
- Non-expectorating CF patients
- Bronchoscopy CF patients
Bronchoalveolar lavageProcedure or surgery
Will be obtained by the pulmonologist in:
- Bronchoscopy CF patients
QuestionnaireOther
Completing questionnaire on acceptability of different sampling methods by patients >6 years of age
| Study group | Role | What they receive |
|---|---|---|
| Expectorating CF patients | (=able to expectorate sputum spontaneously)
1. Nasal swab
2. Cough swab
3. Spontaneous expectorated sputum
4. Questionnaire Receives: Procedure: Nasal swab; Procedure: Cough swab; Procedure: Spontaneous expectorated sputum; Other: Questionnaire | |
| Non-expectorating CF patients | (=unable to expectorate sputum spontaneously)
1. Nasal swab
2. Cough swab
3. Induced sputum after inhalation of hypertonic saline (NaCl 6%)
4. Questionnaire Receives: Procedure: Nasal swab; Procedure: Cough swab; Procedure: Induced sputum; Other: Questionnaire | |
| Bronchoscopy CF patients | (=undergoing clinically indicated bronchoscopy)
1. Nasal swab
2. Cough swab
3. Induced sputum after inhalation of hypertonic saline (NaCl 6%)
4. Bronchoalveolar lavage (BAL) Receives: Procedure: Nasal swab; Procedure: Cough swab; Procedure: Induced sputum; Procedure: Bronchoalveolar lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, positive and negative predicted value
Sensitivity, specificity, positive and negative predicted value of different sampling methods
Measured: 2 years
Secondary outcomes (2)
Preference of method
If no differences are observed between sampling methods, which method would be preferred by the patient?
Measured: Questionnaire: day of sampling, Analysis: 2 years
Pain experienced with any method
Is there any pain experienced? If so, how much? --> VAS
Measured: Questionnaire: day of sampling, Analysis: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanneke Eyns, Universitair Ziekenhuis Brussel
- Investigators
- Anne Malfroot, MD, PhD, Study director, Universitair Ziekenhuis Brussel - Cystic Fibrosis Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363764
- Sponsor's protocol ID
- B.U.N. 143201422976
- Status last verified
- Oct 2016
- First submitted
- 30 Jan 2015
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: All data will be analysed and shared as an original article, individual data will only be available upon motivated request
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Challenge of Obtaining Qualitative Bacterial Cultures in Non-expectorating Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT02363764
- Acronym / sponsor ID
- B.U.N. 143201422976
- Conditions
- Cystic Fibrosis
- Keywords
- respiratory sampling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Feb 2015 (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.
Accurate identification of lower respiratory tract pathogens is standard of care in the management of CF patients and it is therefore recommended to perform regular bacterial cultures, at least once a year, but some even recommend monthly cultures. This can be done through different methods, of which sputum and bronchoalveolar lavage (BAL) are the gold standard. However, BAL is an invasive method, not designated to repeat monthly. Therefore, the diagnosis of lower respiratory tract infections can be challenging in the non-expectorating CF patient. Other methods, such as induced sputum (IS), cough swabs and nasal swabs, have been developed to obtain bacterial cultures in these patients. Studies have investigated the reliability of these different sampling methods, however, with controversial conclusions.
Detailed description
- Protocol design:
The current protocol is designed to compare:
- Group 1: nasal swab, cough swab and spontaneous expectorated sputum in expectorating CF patients
- Group 2: nasal swab, cough swab and induced sputum in non-expectorating CF patients
- Group 3: nasal swab, cough swab, induced sputum and BAL in both expectorating and non-expectorating CF patients requiring clinically indicated bronchoscopy
II. Flow chart:
- Nasal swab obtained by the physiotherapyst (PT)
- Patient rinses his mouth with water, followed by autogenic drainage
- Cough swab obtained by the PT
- Obtainment of 3rd (4th) sample:
- Group 1: Sputum sample voluntary expectorated by the patient
- Group 2 and 3: Induced sputum sample --> voluntary coughed up and expectorated by the patient after inhalation of 4ml of HS OR
- Group 3: BAL -->obtained by the pulmonologist during bronchoscopy
- Filling out questionnaire on acceptability of the different sampling methods by patients >6 years of age (not in Group 3)
III. Analysis of the samples:
(Induced) Sputum samples, cough and nasal swabs are aseptically collected in the appropriate disposable and are immediately sent to the Laboratory for Microbiology and Infection Control of the Universitair Ziekenhuis Brussel, where analyses are carried out within 24h post-sampling.
These analyses include:
- Culture and identification of respiratory pathogens on selective and non-selective media
- Each type of colony will be identified by MALDI-TOF mass spectrometry, completed by other identification tests if needed
- When appropriate, susceptibility tests will be performed on the isolated bacteria
IV. Statistical analysis:
- Determination of sensitivity, specificity, positive predicted value, negative predicted value of the different sampling methods
- Preference for one method over another: crosstabs, Chi-square test
- Pain experienced with any method (Yes/No): Student's t-test
- VAS-scale pain per method: ANOVA
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expectorating CF patients | – | Procedure: Nasal swab, Procedure: Cough swab, Procedure: Spontaneous expectorated sputum, Other: Questionnaire(=able to expectorate sputum spontaneously) 1. Nasal swab 2. Cough swab 3. Spontaneous expectorated sputum 4. Questionnaire |
| Non-expectorating CF patients | – | Procedure: Nasal swab, Procedure: Cough swab, Procedure: Induced sputum, Other: Questionnaire(=unable to expectorate sputum spontaneously) 1. Nasal swab 2. Cough swab 3. Induced sputum after inhalation of hypertonic saline (NaCl 6%) 4. Questionnaire |
| Bronchoscopy CF patients | – | Procedure: Nasal swab, Procedure: Cough swab, Procedure: Induced sputum, Procedure: Bronchoalveolar lavage(=undergoing clinically indicated bronchoscopy) 1. Nasal swab 2. Cough swab 3. Induced sputum after inhalation of hypertonic saline (NaCl 6%) 4. Bronchoalveolar lavage (BAL) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CF patients
Key inclusion criteria (4 listed)
- Both expectorating and non-expectorating CF patients with confirmed diagnosis (sweat test / genotyping)
- All ages
- Attending the UZ Brussel CF Clinic
- Written informed consent from each participant and/or his parents or legal guardian
Key exclusion criteria (2 listed)
- CF patients who underwent lung transplantation
- Denial of participation to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal swabWill be obtained by the physiotherapist in: * Expectorating CF patients * Non-expectorating CF patients * Bronchoscopy CF patients | Procedure or surgery | Bronchoscopy CF patients, Expectorating CF patients, Non-expectorating CF patients |
| Cough swabWill be obtained by the physiotherapist in: * Expectorating CF patients * Non-expectorating CF patients * Bronchoscopy CF patients | Procedure or surgery | Bronchoscopy CF patients, Expectorating CF patients, Non-expectorating CF patients |
| Spontaneous expectorated sputumWill be obtained by the physiotherapist in: - Expectorating CF patients | Procedure or surgery | Expectorating CF patients |
| Induced sputumWill be obtained by the physiotherapist in: * Non-expectorating CF patients * Bronchoscopy CF patients | Procedure or surgery | Bronchoscopy CF patients, Non-expectorating CF patients |
| Bronchoalveolar lavageWill be obtained by the pulmonologist in: - Bronchoscopy CF patients | Procedure or surgery | Bronchoscopy CF patients |
| QuestionnaireCompleting questionnaire on acceptability of different sampling methods by patients >6 years of age | Other | Expectorating CF patients, Non-expectorating CF patients |
Primary outcome
Sensitivity, specificity, positive and negative predicted value
Time frame: 2 years
Sensitivity, specificity, positive and negative predicted value of different sampling methods
2 secondary outcomes
Preference of method
Time frame: Questionnaire: day of sampling, Analysis: 2 years
Pain experienced with any method
Time frame: Questionnaire: day of sampling, Analysis: 2 years
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 4 Oct 2016.
- Individual participant dataSharing planned: No. All data will be analysed and shared as an original article, individual data will only be available upon motivated request
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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.
Anne Malfroot, MD, PhD study director
Universitair Ziekenhuis Brussel - Cystic Fibrosis Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Universitair Ziekenhuis Brussel.
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 4 inclusion and 2 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 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Sensitivity, specificity, positive and negative predicted value (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2016.