NCT06779175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 12, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

January 12, 2025

Last Update Submit

July 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Single and Co-infections in Respiratory Viral Infections

    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.

Secondary Outcomes (1)

  • Risk Factors and Rates of ICU Admission and Mortality in Respiratory Viral Infections

    On 12 January 2025, the retrospective analysis of patients was started. The study is expected to be completed within 3 months.

Study Arms (2)

Viral respiratory infection

Symptomatic and verified viral upper respiratory tract infections in hospitalized patients

Viral respiratory co-infection

Inpatients who are symptomatic and infected with more than one respiratory virus simultaneously

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 38213216BACKGROUND
  • 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.

    PMID: 34866560BACKGROUND
  • 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.

    PMID: 38138118BACKGROUND

MeSH Terms

Conditions

Respiratory Tract InfectionsVirus DiseasesCoinfection

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Özlem Güler, Assist. Prof

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor M.D.

Study Record Dates

First Submitted

January 12, 2025

First Posted

January 16, 2025

Study Start

January 12, 2025

Primary Completion

July 7, 2025

Study Completion

July 7, 2025

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations