Multiplex Respiratory PCR Results in Diabetic Pneumonia Cases (PCR)

The Use of Multiplex Respiratory Polymerase Chain Reaction Test in Patient With Diabetes Mellitus Who Have a Newly Diagnosed of Community-acquired Pneumonia

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.

Study Overview

• Status: Completed
• Conditions: Multiplex Respiratory PCR Results in Diabetic Pneumonia Cases
• Intervention / Treatment: Diagnostic test: multiplex respiratory polymerase chain reaction test

Detailed Description

A total of 151 adults diagnosed with CAP were enrolled. Group 1 composed of patients who had diabetes (n=42) and group 2 consisted of patients who did not have diabetes (n=109). Demographic and clinical data of the subjects were collected and compared statistically.

The multiplex respiratory PCR test positivity of group 1 was statistically higher than group 2 (p=0.004). The most identified nasopharyngeal pathogen was SARSCoV2 in group 1, whereas in group 2, the most prevalent agent was Streptococcus pneumoniae (p=0.002, p=0.628). Furthermore, the amount of procalcitonin, CRP, neutrophil counts and the ratio of neutrophil-to-lymphocyte ratio (NLR) and CRP-to-lymphocyte (CLR) ratio on admission were statistically higher in group 1 than groups 2 (p=0.012, p=0.002, p<<0.001, p=0.001, p=0.001).

Diabetic patients are at greater risk for developing CAP. Therefore, early detection and prompt treatment is crucial for diabetic patients with CAP to avoid morbidity and mortality. Multiplex respiratory PCR test is an important method for identifying the causative agent of CAP rapidly.

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34768
    • Hisar Intercontinental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-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. -

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hisar Intercontinental Hospital
• Investigators: Study Director: Yakup Tomak, Hisar Intercontinental Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: pneumonia, multiplex respiratory PCR test
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: HisarOD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No