Clinical trial NCT06352944: Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children
Official title: Bronchoscopic Derived Bronchoalveolar Lavage Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-cystic Fibrosis Bronchiectasis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged from 6 to 18 years diagnosed with Non-cystic fibrosis bronchiectasis

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

Eligibility criteria: 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.

Primary outcomes:
measure: procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Yasser F abdelrahem, professor
role: STUDY_DIRECTOR
References: