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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363764
• Other study ID #: B.U.N. 143201422976
• Status: Completed
• Phase: N/A
• First received: January 30, 2015
• Last updated: October 2, 2016
• Start date: January 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Procedure:
• Nasal swab
Will be obtained by the physiotherapist in: Expectorating CF patients Non-expectorating CF patients Bronchoscopy CF patients
• Cough swab
Will be obtained by the physiotherapist in: Expectorating CF patients Non-expectorating CF patients Bronchoscopy CF patients
• Spontaneous expectorated sputum
Will be obtained by the physiotherapist in: - Expectorating CF patients
• Induced sputum
Will be obtained by the physiotherapist in: Non-expectorating CF patients Bronchoscopy CF patients
• Bronchoalveolar lavage
Will be obtained by the pulmonologist in: - Bronchoscopy CF patients

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity, positive and negative predicted value	Sensitivity, specificity, positive and negative predicted value of different sampling methods	2 years	No
Secondary	Preference of method	If no differences are observed between sampling methods, which method would be preferred by the patient?	Questionnaire: day of sampling, Analysis: 2 years	No
Secondary	Pain experienced with any method	Is there any pain experienced? If so, how much? --> VAS	Questionnaire: day of sampling, Analysis: 2 years	No