- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06259110
Community-Acquired Pneumonia Diagnosis Through Integrating Novel Microbiological Techniques.
Revolutionizing Community-Acquired Pneumonia Diagnosis Through Integrating Novel Microbiological Techniques for Enhanced Precision
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Areej Saleh
- Phone Number: +201007728031
- Email: areejosama@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
. Evaluation of Novel Microbiological Techniques
Time Frame: baseline
|
Measure sensitivity and specificity of novel microbiological techniques, such as rapid molecular tests, in identifying pathogens associated with CAP.
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAP microbiological diagnosis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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