Acute lower respiratory tract infections (J20-J22) treated in outpatient care caused by RSV, SARS-CoV-2, and other respiratory viruses. J20-J22
Conditions
Interventions
Group 1: • All infants and young children aged < 2 years from the city or district of Würzburg who, during the observation period, present to a participating pediatric practice because of an acute res
at least one acute respiratory symptom, e.g. cough, rhinorrhea/rhinitis, pharyngitis, respiratory distress) and are diagnosed in the practice with an acute lower respiratory tract infection (LRTI) are
stridor / wheezing / grunting
abnormal auscultatory findings such as crackles, rhonchi, crepitations
reduced ventilation, tachypnea
dyspnea, newly occurring apneic episodes, oxygen saturation < 96%.
• In a sample of these children (those presenting to the practice on a predefined weekday), detailed information on disease course i
Sponsors
Universitätsklinikum Würzburg
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: For basic documentation of all registered, potentially eligible outpatient practice LRTI patients - Infants <2 YOA visiting a pediatric practice during the defined RSV Season - AND Patient residence in Würzburg City or County - AND (anamnestic, parent-reported) acute respiratory tract infection (fever plus at least 1 ARI symptom (e.g. cough, coryza/rhinitis, pharyngitis, breathing difficulty) with symptom onset during the last 7 days before the practice visit - AND at least 1 LRTI sign/symptom/diagnosis observed by the pediatrician during the practice visit / auscultation (e.g. retractions [“Einziehungen”] / nasal flaring [“Nasenflügeln”]; stridor/ wheezing/ grunting [“Pfeifen/Giemen/Stöhnen”]; auscultation results, e.g. rales, rhonchi, crackles [“Rasselgeräusche”, ”Brummen”, “Knistern”], insufficient ventilation [“Minderbelüftung”]; tachypnea (age <2 months: =60 breaths/min; age 2 to <6 months: =50 breaths/min, age 6 months to <2 years: =40 breaths/min); dyspnea, apneic episodes (new onset), oxygen saturation <96%). For patients participating in respiratory sampling - AND Written informed consent for “respiratory sampling” For patients participating in extended study documentation - AND Written informed consent for “extended study documentation”
Exclusion criteria
Exclusion criteria: - Patients previously enrolled, if ARI symptoms occur <14 days after recovery from the previous LRTI - Parents with insufficient knowledge of German language or considered unable or unwilling to comply with the study rules
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Estimated incidence of infants <2 YOA with LRTI (overall / RSV-associated / associated with SARS-CoV-2 or other analyzed viral pathogens) in the population <2 YOA in Würzburg City and County (outpatient diagnosed, pediatric-practice population) •Estimated incidence of infants <2 YOA with LRTI (overall / RSV-associated / associated with SARS-CoV-2 or other analyzed viral pathogens) in Würzburg City and County (including data from hospital substudy) •Estimated incidence of infants <2 YOA hospitalized due to LRTI (with documented RSV infection / documented infection with SARS.CoV-2 or other selected viral pathogens) in the population <2 YOA in Würzburg City and County (outpatient diagnosed, pediatric-practice population) •Estimated incidence of infants <2 YOA hospitalized due to LRTI (RSV / SARS-CoV-2 and other analyzed viral pathogens) overall (including directly hospitalized children with LRTI) in Würzburg City and County (including data from hospital substudy) •Proportion of hospitalizations for LRTI due to RSV (from all enrolled LRTI-RSV) and for LRTI due to SARS-CoV-2 and other respiratory viruses (from all enrolled LRTI due to other viral pathogens) in infants <2 YOA treated in the participating practices in Würzburg City and County) | — |
Secondary
| Measure | Time frame |
|---|---|
| The number and proportions of patients (from all enrolled outpatient study participants 38.0°C, and maximum temperature recorded • Duration of disease with flu-like illness (Whitley et al. 2001) • Occurrence (yes/no) of specific diagnoses and complications • Outcome (alive without sequelae, alive with sequelae, deceased) • Outcome regarding recurrent/persisting wheezing and other potential respiratory sequelae after 1, 3, and 12 months (to cover “acute”, “long” and “post” viral infection Exploratory endpoints The proportions of potentially eligible patients from the overall study population and from the participating practices’ population • Number of recorded/screened/enrolled children with laboratory-confirmed viral LRTI, proportion of the overall study population and proportion from the participating practices’ population < 2 YOA • Number of recorded/screened/enrolled children with laboratory-confirmed RSV LRTI, proportion of the overall study population and proportion from the participating practices’ population < 2 YOA The proportions of patients (from all enrolled outpatient participants <2 YOA) or Mean (SD)/Median (IQR), respectively, regarding: • Occurrence (and duration) of healthcare resource utilizations related to LRTI episode (physician consultations, ED, hospitalization, PICU) • Parent days lost for work • Quality of Life (PedsQL Family Impact ModuleTM) of parents/caregivers of infants (<2 years of age) during LRTI due to RSV / other analyzed viral pathogens, collected at Month 1 • Assessment of illness severity by parents by CARIFs (parents/caregivers) at Day 0, Day 3 and Day 6 • Occurrence of viral co-detections • Occurrence and duration of pharmacological treatment for LRTI (including antiviral / antibiotic treatment) • Assessment of the clinical pathway for LRTI (including Physician consultations related to ARI episode / Emergency Department/ Stationary hospitalization /Duration of hospitalization/ PICU / duration of PICU) | — |
Countries
Germany
Contacts
Public ContactJohannes Liese
Universitätsklinikum Würzburg
Outcome results
None listed