Serotype Distribution and Antimicrobial Susceptibility of Streptococcus pneumoniae Associated with Invasive Pneumococcal Disease among Children in Japan

JRCT ID: jRCT1030210333

Registered date:22/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Invasive Pneumococcal Disease
• Date of first enrollment: 26/11/2021
• Target sample size: 200
• Study type: Observational

Outcome(s)

• Primary Outcome: Count and percentage of pneumococcal serotypes detected in pediatric IPD patients and the summary of IPD cases
• Secondary Outcome: Productivity loss among parents/caregivers of patients diagnosed with IPD

Key inclusion & exclusion criteria

• Age minimum: >= 2month old
• Age maximum: < 18age old
• Gender: Both

Include criteria

1. Patient age is between 2 months and17 years
2. Patient has S. pneumoniae positive culture from normally sterile sites (i.e., blood or cerebrospinal, synovial, pleural or pericardial fluid or bone)
3. Parents/legally acceptable representatives (LAR) is willing and able to give informed consent for participation in the study

Exclude criteria

1. Patient has S. pneumoniae positive ear discharge culture related to acute otitis media without bacteremia or S. pneumoniae positive cerebrospinal fluid
2. Patient has S. pneumoniae positive sputum culture related to pneumococcal pneumonia without bacteremia or S. pneumoniae positive cerebrospinal fluid
3. Patient has S. pneumoniae positive culture obtained from the nasopharynx without bacteremia or S. pneumoniae positive cerebrospinal fluid

Related Information

• Primary Sponsor: Abe Machiko