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NCT06352944 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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