Community-Acquired Pneumonia Diagnosis Through Integrating Novel Microbiological Techniques.

Community-acquired Pneumonia Clinical Trial

Official title:

Revolutionizing Community-Acquired Pneumonia Diagnosis Through Integrating Novel Microbiological Techniques for Enhanced Precision

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06259110
• Other study ID #: CAP microbiological diagnosis
• Status: Not yet recruiting
• Start date: February 25, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Areej Saleh
• Phone: +201007728031
• Email: areejosama[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	. Evaluation of Novel Microbiological Techniques	Measure sensitivity and specificity of novel microbiological techniques, such as rapid molecular tests, in identifying pathogens associated with CAP.	baseline

External Links

•   Dilemma-of-community-acquired-pneumonia