Retrospective Observational Multicenter Study on the Burden of Hospitalized Patients With Respiratory Tract Infection

NCT07691216 | Not Yet Recruiting

• 1 other identifier: W26.018
• Study Type: observational
• Target: 70,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This multicenter retrospective real-world data study will evaluate the burden of respiratory tract infection (RTI)-related hospitalizations in up to 10 Dutch hospitals between 2018 and 2026. The study aims to quantify:

• Hospitalization rates
• Healthcare resource utilization (LOS, ICU admissions, readmissions)
• Clinical outcomes (including mortality)
• Direct healthcare costs
• Pathogen-specific burden (e.g., RSV, influenza, SARS-CoV-2) Using linked hospital, laboratory, and administrative data, outcomes will be analyzed by age group, comorbidities, pathogen, and respiratory season. The expected cohort size is approximately 60,000-70,000 patients. The results will provide evidence to support Dutch public health policy, including RSV immunization strategies, healthcare capacity planning, and antimicrobial stewardship.

Conditions

Respiratory Tract Infections (RTI)

Outcome Measures

Primary Outcomes (1)

• Number of RTI-related hospitalisations

  hospitalisation registered under any primary or secondary RTI ICD-10 code

  April 2018 - July 2026

Secondary Outcomes (3)

• ICU admission rate

  April 2018 - July 2026

• ICU length of stay

  April 2018 - July 2026

• In-hospital all-cause mortality rate;

  April 2018 - July 2026

Other Outcomes (4)

• Microbiological testing rate

  April 2018 - July 2026

• Healthcare resource utilization (HCRU) 30 days post-admission

  April 2018 - July 2026

• Direct healthcare costs per RTI-related hospitalisation

  April 2018 - July 2026

Interventions

Respiratory tract infection hospitalisation OTHER

Hospitalisation with a primary or secondary ICD-10 diagnosis of respiratory tract infection (RTI), including infections caused by RSV, influenza, SARS-CoV-2, and other viral or bacterial pathogens, identified through routine administrative and laboratory data.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of all ages (paediatric and adult) admitted to Dutch hospitals with a primary or secondary ICD-10 diagnosis of respiratory tract infection (RTI) during the period April 2018 through July 2026. Patients are identified through routinely collected administrative data (DBC) from up to 10 participating Dutch hospitals, representing a mix of academic, large peripheral, and smaller peripheral centres.

You may qualify if:

• All patients with any care activity during a hospitalisation registered under any primary or secondary RTI ICD-10 code; hospital admission beginning within April 2018 - July 2026.

You may not qualify if:

• Patients who have formally objected to the use of their hospital data for scientific research.

Sponsors & Collaborators

• LOGEX: lead

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 8, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share