Health Condition 1: A403- Sepsis due to Streptococcus pneumoniae
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Abbott India Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female less than 18 years of age at enrollment in the pediatric departments of study sites • Diagnosis of invasive pneumococcal disease (IPD), defined as isolation of Streptococcus pneumoniae on culture or detection of pneumococcal DNA by PCR from a normally sterile body site based on the clinical syndrome • For participants enrolled retrospectively: Availability of details of demographic characteristics, clinical symptoms, comorbidities, and disease progression from diagnosis to study enrollment, with a focus on the duration of illness, severity, and complications (the disease course will be captured until hospital discharge or until recovery). • For participants enrolled retrospectively: Availability of archived isolates and clinical data • For participants enrolled prospectively: Willingness to provide written informed consent by parent/legally authorized representative (LAR) and assent by participants greater than and equal to 7 years of age
Exclusion criteria
Exclusion criteria: • Patients with incomplete medical records and non-availability of adequate biological samples as per the Investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serotype distribution of S. pneumoniae in participantsTimepoint: Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Serotype distribution of S. pneumoniae in participants stratified by age groupTimepoint: Baseline;Incidence of spectrum of IPD and clinical complications (pneumonia, meningitis, septicemia, and others) among participants stratified by serotype of S. pneumoniae isolate(s)Timepoint: Baseline;Antimicrobial susceptibility of S. pneumoniae isolates stratified by serotypeTimepoint: Baseline;Proportion of participants with and without pneumococcal vaccinationTimepoint: Baseline;Serotype distribution of S. pneumoniae in participants stratified by vaccination status (vaccinated vs. nonvaccinated)Timepoint: Baseline;Spectrum of IPD and clinical complications (pneumonia, meningitis, septicemia, and others) in participants stratified by vaccination status (vaccinated vs. nonvaccinated)Timepoint: Baseline;Severity of IPD based on requirement of intensive care and/or ventilation support in participants stratified by vaccination status (vaccinated vs. nonvaccinated)Timepoint: Baseline | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Institute of Child Health
Outcome results
None listed