Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children

Non-cystic Fibrosis Bronchiectasis Clinical Trial

Official title:

Bronchoscopic Derived Bronchoalveolar Lavage Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06352944
• Other study ID #: AssiutMD
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: maram M amir, lecturer
• Phone: 01014808876
• Email: maramamir1994[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers (functional and radiological severity )

Description:

• The severity of bronchiectasis will be assessed using forced expiratory volume in 1s (FEV1), and bronchiectasis severity scores which included bronchiectasis severity index (BSI) , FEV1, chronic colonization, extension of lobes and dyspnea which were performed to assess non-CF bronchiectasis patients.

BSI score

• This score incorporates 9 variables. The total score is calculated by summing the scores for each variable and can range from 0 to 26 points. According to the overall score, patients are classified into three classes: patients with low BSI score (0---4 points), intermediate BSI score (5---8 points), high BSI score (≥9 points)

• chest X ray and HRCT of the chest: to assess the radiological severity of bronchiectasis using the radiological findings will be measured by assessing the most recent chest X ray and HRCT of the chest performed in the last six months using Bhalla score(10)

• Culture and sensitivity from bronchoalveolar lavage for isolation of pseudomonas aeruginosa and any other organism.

• Sputum procalcitonin level was measured in BAL samples using bronchoscopy.

• Bronchoscopy: would be undertaken when the children were in a stable clinical condition as part of their annual review

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Children of both sex

2. Children aged from 6-17 years old.

3. Documented diagnosis of non-CF bronchiectasis by confirmed bronchiectasis findings using high-resolution computed tomographic (HRCT) lung scanning, and clinical symptoms consistent with bronchiectasis with a negative sweat test

Exclusion Criteria:

1. Age less than 6 years or more than 17 years.

2. Children Diagnosed with cystic fibrosis bronchiectasis with confirmed positive sweat chloride test(6).

3. If there was a history of a recent exacerbation during the previous month preceding the study.

Related Conditions & MeSH terms

• Bronchiectasis
• Fibrosis
• Non-cystic Fibrosis Bronchiectasis

Intervention

Diagnostic Test:
• procalcitonin
level of procalcitonin in bronchoalveolar lavage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children	comparison between procalcitonin level in Bronchoalveolar lavage and other markers of severity of bronchiectasis	2 years