Association Between Plasma D Dimer in Adult CAP and Sever... | NCT07199530

Studies
Association Between Plasma D Dimer in Adult CAP and Severity of Inflammatory Response and Survival

NCT07199530

Sponsor

Ain Shams University

Status

Recruiting

Last Update Posted

Feb 24, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

D-dimer

Interventions

Blood Product

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2025Actual

Primary Completion Date

Mar 2026Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Sep 22, 2025

First Submission Date that Met QC Criteria

Sep 22, 2025

First Posted Date

Sep 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2026

Last Update Posted Date

Feb 24, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

hieba gamal ezz-elragal awad, Assistant professor, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational study aims to investigate the association between elevated plasma D-dimer levels and the inflammatory response, as well as its impact on survival in adult patients with community-acquired pneumonia.

the study participants will be subjected to sampling for D-dimer and calculation of CURB-65 score. this aims to find the relation between them

Detailed Description

Community-acquired pneumonia (CAP) is a common and potentially life-threatening infection that affects millions of individuals worldwide each year.

D-dimer is a fibrin degradation product that is elevated in many conditions associated with inflammation and coagulation activation, including pneumonia.

This is an observational study including a minimum of 50 patients with CAP

Patients who will be admitted to the Chest department, or coming to the outpatient clinic at Ain-Shams University Hospitals with CAP, and have the following inclusions:

age ≥18 years
diagnosis of CAP based on clinical symptoms, laboratory findings, and radiological evidence.
Did not have any clinical or radiological signs suggesting COVID-19 pneumonia Exclusion criteria Patients with a history of coagulation disorders, cancer, or other chronic diseases, or refusal to participate.

All patients will be subjected to the following: -

Full medical history, demographics
Thorough clinical examination.
laboratory values (including white blood cell count, CRP, and D-dimer), With pre and post sample known precautions (8).
Radiological findings (CXR).
Severity of illness (based on the CURB-65 score).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
only one group which will include patients with CAP to take a blood sample for D-dimer			Other: Blood Product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood Product	Other	blood sample for D-dimer	only one group which will include patients with CAP to take a blood sample for D-dimer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
find the correlation between plasma D-dimer level and the severity of CAP	measuring D-dimer level (< 500 µg/L consider negative) on admission and correlating this with CAP severity.	in 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who will be admitted to the Chest department, or coming to the outpatient clinic at Ain-Shams University Hospitals with CAP, and have the following inclusions:
1. age ≥18 years
2. diagnosis of CAP based on clinical symptoms, laboratory findings, and radiological evidence.

Exclusion Criteria:

Patients with a history of coagulation disorders, cancer, or other chronic diseases, or refusal to participate.
patients who have any clinical or radiological signs suggesting COVID-19 pneumonia.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

the participant is those patients with CAP WHO will meet the inclusion criteria previously mentioned

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hieba Gamal Ezzelregal	Contact	+201002041611		hiebagamal24@med.asu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University hospitals	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

to save patients DATA

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided