The Challenge of Obtaining Qualitative Bacterial Cultures in Non-expectorating Cystic Fibrosis Patients

October 2, 2016 updated by: Hanneke Eyns, Universitair Ziekenhuis Brussel
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

I. 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:

  1. Nasal swab obtained by the physiotherapyst (PT)
  2. Patient rinses his mouth with water, followed by autogenic drainage
  3. Cough swab obtained by the PT

  4. 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
  5. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

CF patients

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • CF patients who underwent lung transplantation
  • Denial of participation to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Expectorating CF patients

(=able to expectorate sputum spontaneously)

  1. Nasal swab
  2. Cough swab
  3. Spontaneous expectorated sputum
  4. Questionnaire
Procedure: Nasal swab

Will be obtained by the physiotherapist in:

  • Expectorating CF patients
  • Non-expectorating CF patients
  • Bronchoscopy CF patients
Procedure: Cough swab

Will be obtained by the physiotherapist in:

  • Expectorating CF patients
  • Non-expectorating CF patients
  • Bronchoscopy CF patients
Procedure: Spontaneous expectorated sputum

Will be obtained by the physiotherapist in:

- Expectorating CF patients

Other: Questionnaire
Completing questionnaire on acceptability of different sampling methods by patients >6 years of age
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
Procedure: Nasal swab

Will be obtained by the physiotherapist in:

  • Expectorating CF patients
  • Non-expectorating CF patients
  • Bronchoscopy CF patients
Procedure: Cough swab

Will be obtained by the physiotherapist in:

  • Expectorating CF patients
  • Non-expectorating CF patients
  • Bronchoscopy CF patients
Other: Questionnaire
Completing questionnaire on acceptability of different sampling methods by patients >6 years of age
Procedure: Induced sputum

Will be obtained by the physiotherapist in:

  • Non-expectorating CF patients
  • Bronchoscopy CF patients
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)
Procedure: Nasal swab

Will be obtained by the physiotherapist in:

  • Expectorating CF patients
  • Non-expectorating CF patients
  • Bronchoscopy CF patients
Procedure: Cough swab

Will be obtained by the physiotherapist in:

  • Expectorating CF patients
  • Non-expectorating CF patients
  • Bronchoscopy CF patients
Procedure: Induced sputum

Will be obtained by the physiotherapist in:

  • Non-expectorating CF patients
  • Bronchoscopy CF patients
Procedure: Bronchoalveolar lavage

Will be obtained by the pulmonologist in:

- Bronchoscopy CF patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity, positive and negative predicted value
Time Frame: 2 years
Sensitivity, specificity, positive and negative predicted value of different sampling methods
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preference of method
Time Frame: Questionnaire: day of sampling, Analysis: 2 years
If no differences are observed between sampling methods, which method would be preferred by the patient?
Questionnaire: day of sampling, Analysis: 2 years
Pain experienced with any method
Time Frame: Questionnaire: day of sampling, Analysis: 2 years
Is there any pain experienced? If so, how much? --> VAS
Questionnaire: day of sampling, Analysis: 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitair Ziekenhuis Brussel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anne Malfroot, MD, PhD, Universitair Ziekenhuis Brussel - Cystic Fibrosis Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B.U.N. 143201422976

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data will be analysed and shared as an original article, individual data will only be available upon motivated request

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

Clinical Trials on Nasal swab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings