Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02363764
Enrollment
175
Registered
2015-02-16
Start date
2015-01-31
Completion date
2016-10-31
Last updated
2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

respiratory sampling

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

Interventions

PROCEDURENasal swab

Will be obtained by the physiotherapist in: * Expectorating CF patients * Non-expectorating CF patients * Bronchoscopy CF patients

PROCEDURECough swab

Will be obtained by the physiotherapist in: * Expectorating CF patients * Non-expectorating CF patients * Bronchoscopy CF patients

PROCEDURESpontaneous expectorated sputum

Will be obtained by the physiotherapist in: \- Expectorating CF patients

Will be obtained by the physiotherapist in: * Non-expectorating CF patients * Bronchoscopy CF patients

PROCEDUREBronchoalveolar lavage

Will be obtained by the pulmonologist in: \- Bronchoscopy CF patients

OTHERQuestionnaire

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

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity, specificity, positive and negative predicted value2 yearsSensitivity, specificity, positive and negative predicted value of different sampling methods

Secondary

MeasureTime frameDescription
Preference of methodQuestionnaire: day of sampling, Analysis: 2 yearsIf no differences are observed between sampling methods, which method would be preferred by the patient?
Pain experienced with any methodQuestionnaire: day of sampling, Analysis: 2 yearsIs there any pain experienced? If so, how much? --\> VAS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026