NCT06459713

Brief Summary

Multiplex respiratory polymerase chain reaction (PCR) test has gained wide acceptance as an alternative to conventional culture methods for the detection of the causative agent of community-acquired pneumonia (CAP). The aim of this study is to evaluate the positivity and to determine the causative agent of CAP using multiplex respiratory PCR test in patients with diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 31, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
Last Updated

June 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

May 31, 2024

Last Update Submit

May 31, 2024

Conditions

Keywords

pneumonia, multiplex respiratory PCR test

Outcome Measures

Primary Outcomes (1)

  • Diabetic patients are at greater risk for developing CAP. Multiplex respiratory PCR test is an important method for identifying the causative agent of CAP rapidly.

    September 2021 and June 2023

Study Arms (2)

Multiplex respiratory PCR test results of the groups

This single center retrospective observational study was conducted in Hisar Hospital Intercontinental between September 2021 and June 2023

Diagnostic Test: multiplex respiratory polymerase chain reaction test

we evaluated the importance of respiratory PCR in CAP

Subjects who had an infection other than pneumonia, and had a diagnosis of malignancy, transferred to intensive care unit and pregnant women were excluded.

Diagnostic Test: multiplex respiratory polymerase chain reaction test

Interventions

According to our hospital policy, nasopharyngeal swab samples are collected by the clinicians and transported to the Clinical Microbiology Laboratory of the hospital in 10 minutes. The samples are analyzed in 2 hours and the samples were measured by Thermo Fisher / Applied Biosystems Quant Studio-5 for reverse transcription-polymerase chain reaction (RT-PCR) testing to detect multiplex respiratory agents

Multiplex respiratory PCR test results of the groupswe evaluated the importance of respiratory PCR in CAP

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

After the exclusion criteria applied, remaining 151 patients were enrolled in the study. Of the 151 subjects, 42 (27.8%) who were followed up with the confirmed diagnosis of type 2 diabetes mellitus constituted group 1 and 109 (72.2%) ones who did not have a diagnosis of type 2 diabetes mellitus named as group 2. -

You may qualify if:

  • In this study, a population of 190 people over the age of 18 were searched in terms of suitability for this work , who diagnosed with CAP after admission to the Department of Chest Diseases by using a multiplex respiratory PCR test.

You may not qualify if:

  • Subjects who had an infection other than pneumonia, and had a diagnosis of malignancy, transferred to intensive care unit and pregnant women were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hisar Intercontinental Hospital

Istanbul, 34768, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal swab samples

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yakup Tomak

    Hisar Intercontinental Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Biochemistry

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 14, 2024

Study Start

April 1, 2024

Primary Completion

May 15, 2024

Study Completion

May 30, 2024

Last Updated

June 14, 2024

Record last verified: 2024-05

Locations