Clinical trial NCT06459713: Multiplex Respiratory PCR Results in Diabetic Pneumonia Cases
Official title: The Use of Multiplex Respiratory Polymerase Chain Reaction Test in Patient With Diabetes Mellitus Who Have a Newly Diagnosed of Community-acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiplex Respiratory PCR Results in Diabetic Pneumonia Cases
Keywords: pneumonia, multiplex respiratory PCR test
Lead sponsor: Hisar Intercontinental Hospital
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
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. -

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: September 2021 and June 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Hisar Intercontinental Hospital
Study officials:
affiliation: Hisar Intercontinental Hospital
name: Yakup Tomak
role: STUDY_DIRECTOR
References: