NCT05701605

Brief Summary

The current work aims to:

  1. 1.Measure the levels of Neutrophil CD64 Receptor, Monocyte Human Leukocyte Antigen-DR (mHLA-DR), and Triggering Receptor Expressed on Myeloid Cells 1 (TREM-1) in children suffering from pneumonia.
  2. 2.Compare these levels to their levels in healthy control children.
  3. 3.Analyze the cut-off point, sensitivity, specificity, and area under the ROC curve of these biomarkers to test their abilities to early differentiate children with pneumonia from healthy control children.
  4. 4.Conclude or reject their possible use as diagnostic and/or prognostic markers in pediatric pneumonia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

December 17, 2022

Last Update Submit

January 25, 2023

Conditions

Pneumonia in Children

Outcome Measures

Primary Outcomes (3)

  • Measure the level of Neutrophil CD64 Receptor

    a peripheral blood neutrophil CD64

    Baseline

  • Measure the level of Monocyte Human Leukocyte Antigen-DR (mHLA-DR)

    an immune function-related biomarker

    Baseline

  • Measure the level of Triggering Receptor Expressed on Myeloid Cells 1 (TREM-1)

    an inflammatory receptor that causes inflammation after exposure to extracellular fungi and bacterial pathogens

    Baseline

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

60 infant and child aged 1 month to 5 years with pneumonia and 60 normal infant and child of comparable age and sex as control.

You may qualify if:

  • Children more than one month and till age of 5 years
  • Clinical diagnosis of CAP.

You may not qualify if:

  • \) All pediatric patients with comorbidities and diagnosed with CAP as: severe sepsis\& localized infections e.g., endocarditis, empyema\& autoimmune diseases\& liver cirrhosis\& children receiving immunosuppressive therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • El-Sayed Khalil, Prof

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Yasser Farouk, Assist prof

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Khalid Mohany, Assist prof

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nahla Sameh

CONTACT

01096362551nahlasameh8115@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2022

First Posted

January 27, 2023

Study Start

July 1, 2023

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

January 27, 2023

Record last verified: 2023-01