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NCT Number: NCT02363764

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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:

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal Swab

Procedure

Will be obtained by the physiotherapist in:

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

Cough swab

Procedure

Will be obtained by the physiotherapist in:

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

Spontaneous expectorated sputum

Procedure

Will be obtained by the physiotherapist in:

  • Expectorating CF patients

Induced sputum

Procedure

Will be obtained by the physiotherapist in:

  • Non-expectorating CF patients
  • Bronchoscopy CF patients

Bronchoalveolar lavage

Procedure

Will be obtained by the pulmonologist in:

  • Bronchoscopy CF patients

Questionnaire

Other

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

Primary outcomes

  1. Sensitivity, specificity, positive and negative predicted value

    Time frame: 2 years

    Sensitivity, specificity, positive and negative predicted value of different sampling methods

Secondary outcomes

  1. 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?

  2. Pain experienced with any method

    Time frame: Questionnaire: day of sampling, Analysis: 2 years

    Is there any pain experienced? If so, how much? --> VAS

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 16, 2015
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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