Community-Acquired Pneumonia Diagnosis Through Integrating Novel Microbiological Techniques.

NCT ID: NCT06259110

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-25

Study Completion Date

2025-01-01

Brief Summary

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To evaluate novel microbiological techniques for enhanced Pathogen Identification, assess the speed and efficiency of the integrated approach in providing timely diagnostic results, aiming to reduce the turnaround time for CAP diagnosis and subsequently improve patient outcomes and evaluate the clinical impact of enhanced precision in CAP diagnosis on treatment decisions, including the potential for targeted and more effective antimicrobial therapy based on accurate pathogen identification.

Detailed Description

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Community-acquired pneumonia (CAP) is the term used to describe an acute infection of the lungs that develops outside the hospital setting in a patient who has not been recently hospitalized.

Community-acquired pneumonia (CAP) is one of the most common infectious diseases and is a significant cause of mortality and morbidity globally despite preventative measures aimed at combating CAP.

These measures include pneumococcal vaccination of at-risk groups, yearly vaccinations for seasonal influenza viruses and since 2021, SARS-CoV-2 vaccination.

Understanding the etiology of CAP is crucial for accurate empirical antibiotic treatment, updating treatment guidelines, and future vaccine cost-benefit analyses. Currently, microbiological testing for CAP patients does not identify the etiology of most cases.

In contrast, molecular biology techniques, are rapid and sensitive for the diagnosis of pathogens. Furthermore, a multitude of nascent technologies, including multiplex real-time PCR; that detect multiple respiratory pathogens including both bacteria and viruses from a single respiratory tract sample and microarray methodologies, have become accessible for employment in clinical settings.

Improved diagnostics may change the management of CAP infections ,prompt identification of the appropriate organism would allow antibiotic de-escalation, which would decrease cost, adverse drug effects and antibiotic resistance pressure. These clinical interventions potentially translate to a reduced length of stay and financial savings for the patient, as well as an improved therapeutic outcome.

Conditions

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Community-acquired Pneumonia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Multiplex PCR

multiplex PCR is a molecular biology technique that detect multiple respiratory pathogens including both bacteria and viruses from a single respiratory tract sample

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All patients with clinical diagnosis of pneumonia among both sexes
* Age \>18 years Old.

Exclusion Criteria

* Age \<18 years old.
* Patients who refuse to participate in the study.
* patient who acquire infection after hospital admission within 48 hours.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Areej Osama Ali Mohammed Saleh

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Areej Saleh

Role: CONTACT

+201007728031

References

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Metlay JP, Waterer GW, Long AC, Anzueto A, Brozek J, Crothers K, Cooley LA, Dean NC, Fine MJ, Flanders SA, Griffin MR, Metersky ML, Musher DM, Restrepo MI, Whitney CG. Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67. doi: 10.1164/rccm.201908-1581ST.

Reference Type BACKGROUND
PMID: 31573350 (View on PubMed)

Koo SH, Jiang B, Lim PQ, La MV, Tan TY. Development of a rapid multiplex PCR assay for the detection of common pathogens associated with community-acquired pneumonia. Trans R Soc Trop Med Hyg. 2021 Dec 2;115(12):1450-1455. doi: 10.1093/trstmh/trab079.

Reference Type BACKGROUND
PMID: 34017992 (View on PubMed)

Naucler P, Henriques-Normark B, Hedlund J, Galanis I, Granath F, Ortqvist A. The changing epidemiology of community-acquired pneumonia: nationwide register-based study in Sweden. J Intern Med. 2019 Dec;286(6):689-701. doi: 10.1111/joim.12956. Epub 2019 Aug 13.

Reference Type BACKGROUND
PMID: 31278792 (View on PubMed)

Demars Y, Brahier T, Rotzinger DC, Brouillet R, Jaton K, Opota O, Boillat-Blanco N. Utility of Polymerase Chain Reaction in Nasopharyngeal Swabs for Identifying Respiratory Bacteria Causing Community-Acquired Pneumonia. Microbiol Spectr. 2022 Jun 29;10(3):e0037922. doi: 10.1128/spectrum.00379-22. Epub 2022 May 18.

Reference Type BACKGROUND
PMID: 35583335 (View on PubMed)

Nik Zuraina NMN, Mohamad S, Hasan H, Goni MD, Suraiya S. Diagnostic performance of an in-house multiplex PCR assay and the retrospective surveillance of bacterial respiratory pathogens at a teaching hospital, Kelantan, Malaysia. Pathog Glob Health. 2023 Feb;117(1):63-75. doi: 10.1080/20477724.2022.2028378. Epub 2022 Mar 25.

Reference Type BACKGROUND
PMID: 35331083 (View on PubMed)

Hu L, Zhang S, Song W, Dong F, Xie Z, Chen X, Liu M, Cui B, Zhang Y, Zhang R, Wang Q. A sensitive mass spectrometry-based method to identify common respiratory pathogens in children. Microbiol Spectr. 2023 Sep 27;11(5):e0185823. doi: 10.1128/spectrum.01858-23. Online ahead of print.

Reference Type BACKGROUND
PMID: 37754782 (View on PubMed)

Related Links

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Other Identifiers

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CAP microbiological diagnosis

Identifier Type: -

Identifier Source: org_study_id

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