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NCT Number: NCT06352944

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

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 )

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children of both sex
  • Children aged from 6-17 years old.
  • 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

  • Age less than 6 years or more than 17 years.
  • Children Diagnosed with cystic fibrosis bronchiectasis with confirmed positive sweat chloride test(6).
  • If there was a history of a recent exacerbation during the previous month preceding the study.

Treatment and study plan

procalcitonin

Diagnostic Test

level of procalcitonin in bronchoalveolar lavage

Primary outcomes

  1. procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children

    Time frame: 2 years

    comparison between procalcitonin level in Bronchoalveolar lavage and other markers of severity of bronchiectasis

Study contacts

Contact information is provided by the study sponsor or research team.

maram M amir, lecturer

CONTACT

[email protected]

01014808876

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 8, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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