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

Not yet recruiting

• Conditions: Non-cystic Fibrosis Bronchiectasis

• Registration Number: NCT06352944
• Lead Sponsor: Assiut University

Brief 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 )

Detailed 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

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-08
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Study Start: 2024-07
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children	2 years	comparison between procalcitonin level in Bronchoalveolar lavage and other markers of severity of bronchiectasis