- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06779175
Analysis of Single Respiratory Viral Infections Versus Co-infections: Prevalence and ICU Needs in Hospitalized Adults
Analysis of Single Respiratory Viral Infections Versus Co-infections in the Post-pandemic Era: Prevalence and ICU Needs in Hospitalized Adults
The objective of our study is to investigate the prevalence of viral respiratory infections in inpatients following the end of the pandemic. Additionally, the prevalence of patients co-infected with multiple viruses simultaneously will be assessed.
In the secondary part of the study, the development of respiratory tract infections, the need for intensive care, and mortality rates within seven days will also be evaluated, and risk factors for patients with a more severe clinical course will be statistically calculated.
Study Overview
Status
Detailed Description
This study aims to determine the prevalence of viral respiratory agents in hospitalized patients post-COVID-19 and to examine the clinical course of respiratory viral co-infections, which are expected to be more severe.
This study will be conducted retrospectively at Kocaeli University Hospital between May 2023, considered the end date of the pandemic, and January 2024. Patients over 18 years of age will be included, and data will be accessed through the hospital automation system. Patients with SARS-CoV-2 PCR-positive symptoms and those expected to use molnupiravir due to the need for treatment will be considered as COVID-19. Respiratory tract agents will be detected by multiplex PCR from symptomatic inpatients. All patients with influenza will also receive oseltamivir. The distribution of viruses, the need for intensive care hospitalization, and whether they cause death within seven days, as well as the prevalence, clinical course, and risk factors of viral co-infections expected to be clinically more severe in the literature, will also be examined
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kocaeli, Turkey
- Kocaeli University
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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:
- Patients over 18 years of age
- Patients admitted to our clinic or consulted to infectious diseases from other inpatient services.
- Patients diagnosed with upper or lower respiratory tract infections due to viral agents
Exclusion Criteria:
- Patients infected with bacterial agents will not be included in the study.
- Patients admitted from the outpatient clinic were not included in the study plan.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Viral respiratory infection
Symptomatic and verified viral upper respiratory tract infections in hospitalized patients
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Viral respiratory co-infection
Inpatients who are symptomatic and infected with more than one respiratory virus simultaneously
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of Single and Co-infections in Respiratory Viral Infections
Time Frame: On 12 January 2025, the retrospective analysis of patients was started. The study is expected to be completed within 3 months.
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Objective: To determine the prevalence of single respiratory viral infections and co-infections in hospitalized adults after COVID-19 pandemic. Assessment Tool: Hospital automation system for patient demographic and clinical data, and multiplex PCR testing for pathogen detection. Unit of Measure: Percentage of patients with each viral infections |
On 12 January 2025, the retrospective analysis of patients was started. The study is expected to be completed within 3 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Risk Factors and Rates of ICU Admission and Mortality in Respiratory Viral Infections
Time Frame: On 12 January 2025, the retrospective analysis of patients was started. The study is expected to be completed within 3 months.
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Objective: To assess the risk factors for ICU admission and seven-day mortality in patients with respiratory viral infections Assessment Tool: Patient records for ICU admission and mortality data, combined with statistical analysis to identify risk factors. Unit of Measure: Odds ratios for ICU admission and mortality. |
On 12 January 2025, the retrospective analysis of patients was started. The study is expected to be completed within 3 months.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Özlem Güler, Assist. Prof, Kocaeli University
Publications and helpful links
General Publications
- Shan N, Zheng Z. A Case of Nosocomial Coinfection of SARS-CoV-2 and Influenza A Virus in a Hospitalized Patient with Acute Myocardial Infarction. Clin Lab. 2024 Jan 1;70(1). doi: 10.7754/Clin.Lab.2023.230735.
- Kanji JN, Zelyas N, Pabbaraju K, Granger D, Wong A, Murphy SA, Buss E, MacDonald C, Berenger BM, Diggle MA, Marshall NC, Conly JM, Tipples G. Respiratory virus coinfections with severe acute respiratory coronavirus virus 2 (SARS-CoV-2) continue to be rare one year into the coronavirus disease 2019 (COVID-19) pandemic in Alberta, Canada (June 2020-May 2021). Infect Control Hosp Epidemiol. 2023 May;44(5):805-808. doi: 10.1017/ice.2021.495. Epub 2021 Dec 6.
- Mochan E, Sego TJ. Mathematical Modeling of the Lethal Synergism of Coinfecting Pathogens in Respiratory Viral Infections: A Review. Microorganisms. 2023 Dec 13;11(12):2974. doi: 10.3390/microorganisms11122974.
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOKAEK-2024/05.17 2024/140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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