Microbial InfectionNCT06759662
Association of Neutrophil- Lymphocyte Count Ratio and Microbial Infection in Hospitalized Patients
An observational study of Microbial Infection, run by Assiut University.
Trial summary
Microbial infection is one of leading cause of morbidity and mortality in the world. Bacteremia that result from microbial infection has mortality rate as high as 30% . Systemic infections that result from microbial infection is a generalized disease that progresses rapidly and can lead to high mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microbial Infection
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 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: All cases diagnosed with microbial infections at Assiut university hospitals.
Who may be able to join
- age more than 18 years old
- both sex
- conformed diagnosis with micorbial infection
Who cannot join
- Immunodeficiency patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Microbial infection is one of leading cause of morbidity and mortality in the world. Bacteremia that result from microbial infection has mortality rate as high as 30% . Systemic infections that result from microbial infection is a generalized disease that progresses rapidly and can lead to high mortality. This infection sets in from a progression of various pathogenic microorganisms that enter the bloodstream, reproduce and then release toxins and metabolites . Early diagnosis of microbial infection is essential for treatment. Culturing microorganisms is the most definitive way to confirm bacterial infections. Unfortunately, this gold standard is time consuming and may take from 24 to 48 hours and sometimes up to a week. A number of rapid initial indicators of microbial infection have been proposed, including C-reactive protein, neutrophil count, and white blood cell count. However, these criteria do not always reliably distinguish between severe bacterial, fungal, and viral infections . Therefore, the neutrophil-to-lymphocyte ratio (NLCR), a simple ratio between the number of neutrophils and lymphocytes measured in peripheral blood, has been proposed as a biomarker that combines two aspects of the immune system: the innate immune response, which is mainly driven by neutrophils, and adaptive immunity, supported by lymphocytes . This study aims to determine the diagnostic value of the neutrophil-to-lymphocyte ratio (NLCR) as an indicator of microbial infection, using complete blood count to determine the ratio in addition to culture and sensitivity according to the site of infection.
the aim of this study is to Investigating the association between neutrophil-lymphocyte count and the presence of microbial infection in the hospitalized patients.
Read the detailed description
Microbial infection is one of leading cause of morbidity and mortality in the world. Bacteremia that result from microbial infection has mortality rate as high as 30% . Systemic infections that result from microbial infection is a generalized disease that progresses rapidly and can lead to high mortality. This infection sets in from a progression of various pathogenic microorganisms that enter the bloodstream, reproduce and then release toxins and metabolites . Early diagnosis of microbial infection is essential for treatment. Culturing microorganisms is the most definitive way to confirm bacterial infections. Unfortunately, this gold standard is time consuming and may take from 24 to 48 hours and sometimes up to a week. A number of rapid initial indicators of microbial infection have been proposed, including C-reactive protein, neutrophil count, and white blood cell count. However, these criteria do not always reliably distinguish between severe bacterial, fungal, and viral infections . Therefore, the neutrophil-to-lymphocyte ratio (NLCR), a simple ratio between the number of neutrophils and lymphocytes measured in peripheral blood, has been proposed as a biomarker that combines two aspects of the immune system: the innate immune response, which is mainly driven by neutrophils, and adaptive immunity, supported by lymphocytes . This study aims to determine the diagnostic value of the neutrophil-to-lymphocyte ratio (NLCR) as an indicator of microbial infection, using complete blood count to determine the ratio in addition to culture and sensitivity according to the site of infection.
- Conditions
- Microbial Infection
- Keywords
- neutrophil- lymphocyte count ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| microbial infections cases | All cases diagnosed with microbial infections at Assiut university hospitals |
What is being measured
The primary outcome is the main question the study is designed to answer.
neutrophil-lymphocyte count ratio
neutrophil-lymphocyte count ratio in the hospitalized patients with microbial infection
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial InfectionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Hamed Abdelwahed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759662
- Sponsor's protocol ID
- N-L count ratio microbial inf
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Neutrophil- Lymphocyte Count Ratio and Microbial Infection in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT06759662
- Acronym / sponsor ID
- N-L count ratio microbial inf
- Conditions
- Microbial Infection
- Keywords
- neutrophil- lymphocyte count ratio
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 6 Jan 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.
Microbial infection is one of leading cause of morbidity and mortality in the world. Bacteremia that result from microbial infection has mortality rate as high as 30% . Systemic infections that result from microbial infection is a generalized disease that progresses rapidly and can lead to high mortality. This infection sets in from a progression of various pathogenic microorganisms that enter the bloodstream, reproduce and then release toxins and metabolites . Early diagnosis of microbial infection is essential for treatment. Culturing microorganisms is the most definitive way to confirm bacterial infections. Unfortunately, this gold standard is time consuming and may take from 24 to 48 hours and sometimes up to a week. A number of rapid initial indicators of microbial infection have been proposed, including C-reactive protein, neutrophil count, and white blood cell count. However, these criteria do not always reliably distinguish between severe bacterial, fungal, and viral infections . Therefore, the neutrophil-to-lymphocyte ratio (NLCR), a simple ratio between the number of neutrophils and lymphocytes measured in peripheral blood, has been proposed as a biomarker that combines two aspects of the immune system: the innate immune response, which is mainly driven by neutrophils, and adaptive immunity, supported by lymphocytes . This study aims to determine the diagnostic value of the neutrophil-to-lymphocyte ratio (NLCR) as an indicator of microbial infection, using complete blood count to determine the ratio in addition to culture and sensitivity according to the site of infection.
the aim of this study is to Investigating the association between neutrophil-lymphocyte count and the presence of microbial infection in the hospitalized patients.
Detailed description
Microbial infection is one of leading cause of morbidity and mortality in the world. Bacteremia that result from microbial infection has mortality rate as high as 30% . Systemic infections that result from microbial infection is a generalized disease that progresses rapidly and can lead to high mortality. This infection sets in from a progression of various pathogenic microorganisms that enter the bloodstream, reproduce and then release toxins and metabolites . Early diagnosis of microbial infection is essential for treatment. Culturing microorganisms is the most definitive way to confirm bacterial infections. Unfortunately, this gold standard is time consuming and may take from 24 to 48 hours and sometimes up to a week. A number of rapid initial indicators of microbial infection have been proposed, including C-reactive protein, neutrophil count, and white blood cell count. However, these criteria do not always reliably distinguish between severe bacterial, fungal, and viral infections . Therefore, the neutrophil-to-lymphocyte ratio (NLCR), a simple ratio between the number of neutrophils and lymphocytes measured in peripheral blood, has been proposed as a biomarker that combines two aspects of the immune system: the innate immune response, which is mainly driven by neutrophils, and adaptive immunity, supported by lymphocytes . This study aims to determine the diagnostic value of the neutrophil-to-lymphocyte ratio (NLCR) as an indicator of microbial infection, using complete blood count to determine the ratio in addition to culture and sensitivity according to the site of infection.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| microbial infections cases | – | –All cases diagnosed with microbial infections at Assiut university hospitals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases diagnosed with microbial infections at Assiut university hospitals.
Key inclusion criteria (3 listed)
- age more than 18 years old
- both sex
- conformed diagnosis with micorbial infection
Key exclusion criteria (1 listed)
- Immunodeficiency patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
neutrophil-lymphocyte count ratio
Time frame: baseline
neutrophil-lymphocyte count ratio in the hospitalized patients with microbial infection
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 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Infections
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Infection, run by Assiut University.
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 1 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: opening soon, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Asmaa Hamed Abdelwahed Mohamed, residant doctor (+201019844307, asmaa26hamed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neutrophil-lymphocyte count ratio (time frame: baseline). 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 6 Jan 2025.