id.DRIVE pilot study to assess the detection of RSV, hMPV and PIV when using multi-specimen collection compared to a single nasopharyngeal swab

Study type

• Study topic:
  Disease /health condition

  Medical procedure
• Study topic, other:
  Diagnosis methods
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Method development or testing
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Respiratory pathogen panel

  Infection
• Additional medical condition(s):
  (Severe) Acute Respiratory Infection ((S)ARI), parainfluenza virus, respiratory syncytial virus, human metapneumovirus

Population studied

• Short description of the study population:
  Hospitalised (S)ARI patients, (S)ARI patients at emergency departments, (S)ARI patients in general practitioner practices
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  1074

Study design details

• Study design:
  Prospective cohort
• Main study objective:
  To assess the detection rates (%) of Respiratory Syncytial Virus (RSV), human Metapneumovirus (hMPV) and Parainfluenzavirus (PIV) in adult (S)ARI patients (≥18 years), when using multi-specimen collection (oropharyngeal swab, saliva, sputum and blood) compared to a single nasopharyngeal swab, overall and by additional specimen type.
• Setting:
  Multi-setting (450 hospitalised study participants + 624 study participants recruited from emergency departments and general practitioner practices).
• Comparators:
  Detection rates in different specimen types
• Outcomes:
  (S)ARI associated with RSV and/or PIV and/or hMPV
• Data analysis plan:
  The analysis are mainly descriptive in nature. Demographic and clinical characteristics of the patients will be described both overall and by respiratory pathogen positivity or other stratifications. Euler diagrams will be used to visually represent the overlap in pathogen detection across specimen types. Positive laboratory results for each respiratory pathogen of interest will be reported by specimen type. This includes nasopharyngeal swabs, saliva, blood, and sputum. Serology is considered positive for recent infection if a fourfold or greater rise in virus-specific IgG antibodies is observed between paired samples. For each specimen type, the percentage of positive diagnoses will be calculated by dividing the number of patients in whom the pathogen was detected using that specimen (alone or in combination) by the total number of included patients.