NCT06259110

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

February 25, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

January 22, 2024

Last Update Submit

February 6, 2024

Conditions

Keywords

Microbiological techniquesMultiplex PCRCommunity-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

  • . 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

Interventions

Multiplex PCRDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with clinical diagnosis of pneumonia who acquire infection outside hospital setting

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 31573350BACKGROUND
  • 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.

    PMID: 34017992BACKGROUND
  • 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.

    PMID: 31278792BACKGROUND
  • 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.

    PMID: 35583335BACKGROUND
  • 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.

    PMID: 35331083BACKGROUND
  • 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.

    PMID: 37754782BACKGROUND

Related Links

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

January 22, 2024

First Posted

February 14, 2024

Study Start

February 25, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

February 14, 2024

Record last verified: 2024-02