Surveillance of Invasive Pneumococcal Disease (IPD) in Indian Children: A Multicentric, Ambispective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 202
- 试验地点
- 7
- 主要终点
- Serotype distribution of S. pneumoniae in participants
研究概览
简要总结
• Eligible children with confirmed diagnosis of IPD as per routine clinical practice (culture-positive on automated method or confirmed using qualitative reverse transcription-polymerase chain reaction (RT-PCR)) will be recruited in the study.
• Eligible children will be enrolled prospectively and retrospectively.
• Written informed consent will be obtained from parent/legally authorized representative (LAR) for prospectively-enrolled participants.
• Assent will be obtained from prospectively-enrolled participants greater than and equal to 7 years of age
• Anonymized data will be used for all participants.
• Information on demographic data, comorbidities/congenital abnormalities, vaccination status, antimicrobial susceptibility (and classification thereof as susceptible, intermediate, or resistant, if available), etc. will be recorded, for prospectively-enrolled participants and for participants enrolled retrospectively.
• Prospectively-enrolled participants will undergo treatment as per routine clinical practice.
• Treatment details (including antibiotic administration, if any, after antimicrobial susceptibility testing) will be retrieved from medical records of prospectively- and retrospectively-enrolled participants.
• Information on complications (pneumonia, meningitis, septicemia, and others) and disease course (until hospital discharge or until recovery) will be retrieved from medical records for prospectively- and retrospectively-enrolled participants.
• Samples, pneumococcal isolates, and DNA from confirmed isolates will be stored at site laboratories according to standard operating procedures (SOPs) and routine clinical practice.
• Samples, pneumococcal isolates, or DNA from confirmed isolates will be transported from site laboratories to Kempegowda Institute of Medical Sciences (KIMS), Bangalore, for the identification of pneumococcal serotypes by molecular typing.
• All inter-laboratory transfers (as required) will be done on a periodic basis according to biosafety guidelines and as per SOPs: bacterial cultures will be stored at the sites, if required, as glycerol stocks at –80ºC. These will be streaked on bacterial plates, allowed to grow overnight, sealed appropriately, and then transported on cold packs.
• Serotyping of isolates will be performed at the central laboratory (KIMS, Bangalore). Well-established primer-probe sets (as per CDC protocols) will be used for identifying the serotypes 1, 3, 4, 5, 6A/B, 7F, 7C, 8, 9V, 10A, 11A, 12F, 14, 15A, 15B/C, 16F, 17F, 18, 19A, 19F, 20, 22F, 23F, 31, 33, 34, 35B, 35F, and/or additional serotypes, as possible. Oligonucleotide sequences and cycling conditions will be adapted from published protocols (CDC, Atlanta).
• Results will be shared by KIMS, Bangalore, within 15 working days from receipt of samples.
• All data will be retrieved from medical records of patients.
• The data will be analyzed using appropriate statistical methods (as described in Section 10.2).
• An interim report will be prepared after all outcome measures are analyzed for a total of at least 50 isolates.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •• 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.
排除标准
- •Patients with incomplete medical records and non-availability of adequate biological samples as per the Investigator’s discretion.
结局指标
主要结局
Serotype distribution of S. pneumoniae in participants
时间窗: Baseline
次要结局
- Serotype distribution of S. pneumoniae in participants stratified by age group(Baseline)
- Incidence of spectrum of IPD and clinical complications (pneumonia, meningitis, septicemia, and others) among participants stratified by serotype of S. pneumoniae isolate(s)(Baseline)
- Antimicrobial susceptibility of S. pneumoniae isolates stratified by serotype(Baseline)
- Proportion of participants with and without pneumococcal vaccination(Baseline)
- Serotype distribution of S. pneumoniae in participants stratified by vaccination status (vaccinated vs. nonvaccinated)(Baseline)
- Spectrum of IPD and clinical complications (pneumonia, meningitis, septicemia, and others) in participants stratified by vaccination status (vaccinated vs. nonvaccinated)(Baseline)
- Severity of IPD based on requirement of intensive care and/or ventilation support in participants stratified by vaccination status (vaccinated vs. nonvaccinated)(Baseline)
研究者
Dr Monjori Mitra
Institute of Child Health