Multiplex Respiratory PCR Results in Diabetic Pneumonia CasesPCRNCT06459713
Multiplex Respiratory PCR Results in Diabetic Pneumonia Cases
An observational study of Multiplex Respiratory PCR Results in Diabetic Pneumonia Cases, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiplex Respiratory PCR Results in Diabetic Pneumonia Cases
- What is being tested?
- multiplex respiratory polymerase chain reaction test
- How many people
- 151 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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. -
Who may be able to join
- 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.
Who cannot join
- Subjects who had an infection other than pneumonia, and had a diagnosis of malignancy, transferred to intensive care unit and pregnant women were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hisar Intercontinental Hospital
Istanbul, 34768
About this study
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
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.
Read the 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.
- Being tested
- multiplex respiratory polymerase chain reaction test
- Keywords
- pneumonia, multiplex respiratory PCR test
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiplex respiratory polymerase chain reaction testDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: multiplex respiratory polymerase chain reaction test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: September 2021 and June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Apr 2024
- Primary completion15 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiplex Respiratory PCR Results in Diabetic Pneumonia CasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bekir Sami Uyanık, Hisar Intercontinental Hospital
- Investigators
- Yakup Tomak, Study director, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459713
- Sponsor's protocol ID
- HisarOD
- Acronym
- PCR
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06459713
- Acronym / sponsor ID
- PCR / HisarOD
- Keywords
- pneumonia, multiplex respiratory PCR test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiplex respiratory PCR test results of the groups | – | Diagnostic Test: multiplex respiratory polymerase chain reaction testThis single center retrospective observational study was conducted in Hisar Hospital Intercontinental between September 2021 and June 2023 |
| we evaluated the importance of respiratory PCR in CAP | – | Diagnostic Test: multiplex respiratory polymerase chain reaction testSubjects who had an infection other than pneumonia, and had a diagnosis of malignancy, transferred to intensive care unit and pregnant women were excluded. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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. -
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects who had an infection other than pneumonia, and had a diagnosis of malignancy, transferred to intensive care unit and pregnant women were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multiplex respiratory polymerase chain reaction testAccording 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 | Diagnostic test | Multiplex respiratory PCR test results of the groups, we evaluated the importance of respiratory PCR in CAP |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yakup Tomak study director
Hisar Intercontinental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiplex Respiratory PCR Results in Diabetic Pneumonia Cases, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: September 2021 and June 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.