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

NCT ID: NCT02363764

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 175 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-10-31

Brief 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. 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

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

Conditions

Cystic Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Expectorating CF patients

(=able to expectorate sputum spontaneously)

1. Nasal swab

2. Cough swab

3. Spontaneous expectorated sputum

4. Questionnaire

Nasal swab

Intervention Type: PROCEDURE

Will be obtained by the physiotherapist in:

• Expectorating CF patients
• Non-expectorating CF patients
• Bronchoscopy CF patients

Cough swab

Intervention Type: PROCEDURE

Will be obtained by the physiotherapist in:

• Expectorating CF patients
• Non-expectorating CF patients
• Bronchoscopy CF patients

Spontaneous expectorated sputum

Intervention Type: PROCEDURE

Will be obtained by the physiotherapist in:

• Expectorating CF patients

Questionnaire

Intervention Type: OTHER

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

Nasal swab

Intervention Type: PROCEDURE

Will be obtained by the physiotherapist in:

• Expectorating CF patients
• Non-expectorating CF patients
• Bronchoscopy CF patients

Cough swab

Intervention Type: PROCEDURE

Will be obtained by the physiotherapist in:

• Expectorating CF patients
• Non-expectorating CF patients
• Bronchoscopy CF patients

Induced sputum

Intervention Type: PROCEDURE

Will be obtained by the physiotherapist in:

• Non-expectorating CF patients
• Bronchoscopy CF patients

Questionnaire

Intervention Type: OTHER

Completing questionnaire on acceptability of different sampling methods by patients \>6 years of age

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)

Nasal swab

Intervention Type: PROCEDURE

Will be obtained by the physiotherapist in:

• Expectorating CF patients
• Non-expectorating CF patients
• Bronchoscopy CF patients

Cough swab

Intervention Type: PROCEDURE

Will be obtained by the physiotherapist in:

• Expectorating CF patients
• Non-expectorating CF patients
• Bronchoscopy CF patients

Induced sputum

Intervention Type: PROCEDURE

Will be obtained by the physiotherapist in:

• Non-expectorating CF patients
• Bronchoscopy CF patients

Bronchoalveolar lavage

Intervention Type: PROCEDURE

Will be obtained by the pulmonologist in:

• Bronchoscopy CF patients

Interventions

Nasal swab

Will be obtained by the physiotherapist in:

• Expectorating CF patients
• Non-expectorating CF patients
• Bronchoscopy CF patients

Intervention Type: PROCEDURE

Cough swab

Will be obtained by the physiotherapist in:

• Expectorating CF patients
• Non-expectorating CF patients
• Bronchoscopy CF patients

Intervention Type: PROCEDURE

Spontaneous expectorated sputum

Will be obtained by the physiotherapist in:

• Expectorating CF patients

Intervention Type: PROCEDURE

Induced sputum

Will be obtained by the physiotherapist in:

• Non-expectorating CF patients
• Bronchoscopy CF patients

Intervention Type: PROCEDURE

Bronchoalveolar lavage

Will be obtained by the pulmonologist in:

• Bronchoscopy CF patients

Intervention Type: PROCEDURE

Questionnaire

Completing questionnaire on acceptability of different sampling methods by patients \>6 years of age

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Hanneke Eyns

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Malfroot, MD, PhD

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel - Cystic Fibrosis Clinic

Other Identifiers

B.U.N. 143201422976

Identifier Type: -

Identifier Source: org_study_id