- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06459713
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
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34768
- Hisar Intercontinental Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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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
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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.
|
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 |
|---|---|
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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.
Time Frame: September 2021 and June 2023
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September 2021 and June 2023
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yakup Tomak, Hisar Intercontinental Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HisarOD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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