NCT06352944

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 )

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jul 2024Jul 2026

First Submitted

Initial submission to the registry

April 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 3, 2024

Last Update Submit

April 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

procalcitoninDIAGNOSTIC_TEST

level of procalcitonin in bronchoalveolar lavage

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yasser F abdelrahem, professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

maram M amir, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 8, 2024

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share