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

April 15, 2024 updated by: Maram Mohamed Amir Fathy, Assiut University

Bronchoscopic Derived Bronchoalveolar Lavage 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 )

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children aged from 6 to 18 years diagnosed with Non-cystic fibrosis bronchiectasis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Yasser F abdelrahem, professor, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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