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

NCT02363764 | Completed DMC

• 1 other identifier: B.U.N. 143201422976
• Study Type: observational
• Target: 175
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis

Keywords

respiratory sampling

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity, positive and negative predicted value

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

  2 years

Secondary Outcomes (2)

• Preference of method

  Questionnaire: day of sampling, Analysis: 2 years

• Pain experienced with any method

  Questionnaire: day of sampling, Analysis: 2 years

Study Arms (3)

Expectorating CF patients

(=able to expectorate sputum spontaneously) 1. Nasal swab 2. Cough swab 3. Spontaneous expectorated sputum 4. Questionnaire

Procedure: Nasal swab; Procedure: Cough swab; Procedure: Spontaneous expectorated sputum; Other: Questionnaire

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; Procedure: Cough swab; Procedure: Induced sputum; Other: Questionnaire

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; Procedure: Cough swab; Procedure: Induced sputum; Procedure: Bronchoalveolar lavage

Interventions

Nasal swab PROCEDURE

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

Bronchoscopy CF patients; Expectorating CF patients; Non-expectorating CF patients

Cough swab PROCEDURE

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

Bronchoscopy CF patients; Expectorating CF patients; Non-expectorating CF patients

Spontaneous expectorated sputum PROCEDURE

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

Expectorating CF patients

Induced sputum PROCEDURE

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

Bronchoscopy CF patients; Non-expectorating CF patients

Bronchoalveolar lavage PROCEDURE

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

Bronchoscopy CF patients

Questionnaire OTHER

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

Expectorating CF patients; Non-expectorating CF patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CF patients

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Bronchoalveolar Lavage; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anne Malfroot, MD, PhD

  Universitair Ziekenhuis Brussel - Cystic Fibrosis Clinic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 16, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share