Clinical trial NCT06779175: Analysis of Single Respiratory Viral Infections Versus Co-infections: Prevalence and ICU Needs in Hospitalized Adults
Official title: Analysis of Single Respiratory Viral Infections Versus Co-infections in the Post-pandemic Era: Prevalence and ICU Needs in Hospitalized Adults
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Respiratory Tract Infections
Virus Diseases
Coinfection
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients over 18 years of age who are hospitalized, have symptoms of respiratory tract infection, and have a positive result for a respiratory tract virus detected by PCR. Patients with SARS-CoV-2 PCR-positive symptoms who require antiviral treatment will be classified as cases of COVID-19.

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Single and Co-infections in Respiratory Viral Infections
timeFrame: On 12 January 2025, the retrospective analysis of patients was started. The study is expected to be completed within 3 months.
Secondary outcomes:
measure: Risk Factors and Rates of ICU Admission and Mortality in Respiratory Viral Infections
timeFrame: On 12 January 2025, the retrospective analysis of patients was started. The study is expected to be completed within 3 months.
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Özlem Güler, Assist. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.