D-dimerNCT07199530
Association Between Plasma D Dimer in Adult CAP and Severity of Inflammatory Response and Survival
An observational study of D-dimer, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- D-dimer
- What is being tested?
- Blood Product
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Mar 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the participant is those patients with CAP WHO will meet the inclusion criteria previously mentioned
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University hospitals
Cairo
Hieba gamal Ezzelregal, +201002041611, hiebagamal24@med.asu.edu.eg
About this study
Official title: Association Between Elevated Plasma D-dimer in Adult Community-acquired Pneumonia Patients and Severity of Inflammatory Response and Survival
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
Read the 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).
- Conditions
- D-dimer
- Being tested
- Blood Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood ProductOther
blood sample for D-dimer
| Study group | Role | What they receive |
|---|---|---|
| only one group which will include patients with CAP to take a blood sample for D-dimer | Not described Receives: Other: Blood Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: in 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start23 Mar 2025
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D-dimerStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hieba gamal ezz-elragal awad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199530
- Sponsor's protocol ID
- FAMSU R 135/2025
- Status last verified
- Feb 2026
- First submitted
- 22 Sep 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to save patients DATA
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Elevated Plasma D-dimer in Adult Community-acquired Pneumonia Patients and Severity of Inflammatory Response and Survival
- ClinicalTrials.gov ID
- NCT07199530
- Acronym / sponsor ID
- FAMSU R 135/2025
- Conditions
- D-dimer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 23 Mar 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| only one group which will include patients with CAP to take a blood sample for D-dimer | – | Other: Blood Product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the participant is those patients with CAP WHO will meet the inclusion criteria previously mentioned
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Productblood sample for D-dimer | Other | only one group which will include patients with CAP to take a blood sample for D-dimer |
Primary outcome
find the correlation between plasma D-dimer level and the severity of CAP
Time frame: in 6 months
measuring D-dimer level (< 500 µg/L consider negative) on admission and correlating this with CAP severity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No. to save patients DATA
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of D-dimer, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hieba Gamal Ezzelregal (+201002041611, hiebagamal24@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
find the correlation between plasma D-dimer level and the severity of CAP (time frame: in 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.