Acute Phase Reactant in Non-COVID-19 Bacterial Pneumonia | NCT05926089

Studies
Acute Phase Reactant in Non-COVID-19 Bacterial Pneumonia

NCT05926089

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jul 14, 2023Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Pneumonia
Acute-Phase Reaction

Interventions

Blood sampling

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

May 30, 2021Actual

First Submitted Date

Jun 28, 2023

First Submission Date that Met QC Criteria

Jun 28, 2023

First Posted Date

Jul 3, 2023Actual

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

Jul 12, 2023

Last Update Posted Date

Jul 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eman Kamal Ibrahim Hassan, Assistant Professor of pulmonology, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 study is a cross-sectional study, was conducted at Chest department of Kasr Al-ainy Hospital, Cairo university during the period between October 2020 and April 2021.

The aim of the work was to evaluate levels of acute phase reactants(APR) in Non-COVID-19 bacterial pneumonia, and to correlate between levels of APR and the disease severity.

Detailed Description

51 patients were included in our study, diagnosed as Non-COVID pneumonia

Inclusion criteria:

PCR(polymerase chain reaction) negative for COVID.
All patients of both sexes with pneumonia .

Exclusion criteria:

Non pulmonary infections.
Post surgery patients.
Renal patients.
hepatic patients.
Cardiac patients.
Recent pulmonary embolism.

Methodology in details:

All patients were subjected to:

Full history with emphasis on:
- Epidemiological features (age, gender).
- Risk factors (smoking, DM).
- Clinical presentation (cough, Fever and duration of illness).
Clinical examination (local chest examination).
Laboratory investigations: venous blood samples were taken to measure APR

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

Retention

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sampling	Diagnostic Test	blood sampling to measure APR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
measurement of APR levels in non-Covid-19 pneumonia	assessment of the level of APR and its relation to disease severity	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COVID-19 negative bacterial pneumonia

Exclusion Criteria:

COVID-19 positive
other non-pulmonary infections

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

All patients( 51 patients diagnosed as non-COVID19 Pneumonia) were subjected to:

Full historywith emphasis on:
- Epidemiological features .
- Risk factors (smoking, DM).
- Clinical presentation (cough, Fever and duration of ilness).
Clinical examination (local chest examination).
Laboratory investigations: venous blood samples were taken for:• Complete blood picture, differential leucocytic count and platelets count, ESR ,CRP, d-dimer and ferritin

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr alainy school of medicine		Cairo		11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia
D000210	Acute-Phase Reaction

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided

Description

• Complete blood picture, differential leucocytic count and platelets count: Done by The newly developed automated hematology analyzer (Sysmex, Kobe, Japan) enumerates and classifies blood cells by a combination of direct current detection and flow cytometry. (Daves et al., 2015).