Department of Pediatrics, Dayanand Medical College and Hospital
Tagore Nagar, Civil Lines, Ludhiana-141001, Punjab Ludhiana PUNJAB
7888365923
dr.gurpreetsingh@yahoo.in
Dr Alikana Deepak Kumar
Government Medical College and Government General Hospital, Cantonment Vizianagaram
Department of Paediatrics, Government Medical College and Government General Hospital, Cantonment Vizianagaram-535003, Andhra Pradesh, India Vizianagaram ANDHRA PRADESH
9866603224
dradeepakkumarresearch@gmail.com
Dr Monjori Mitra
Institute of Child Health
Room Number-113, Department of Paediatrics, Institute of Child Health
11, Dr. Biresh Guha Street
Kolkata-700017 Kolkata WEST BENGAL
9831075734
monjorimr@gmail.com
Dr Prashanth SN
JSS Hospital, Mysuru
Department of Pediatrics, JSS Hospital ,Mahatma Gandhi Road, Mysuru, Karnataka, Pin- 570029 Mysore KARNATAKA
9886553398
prashanthsnped@yahoo.co.in
Dr Nikhil Pathak
Kamalnayan Bajaj Hospital
Department of Paediatrics, Kamalnayan Bajaj Hospital, Gut.No.43, Satara Parisar, Beed Bypass, Chha. Sambhajinagar -431010, Maharashtra Aurangabad MAHARASHTRA
9823086820
nikhilpathak26@gmail.com
Dr Ashish Bavdekar
KEM Hospital Research Centre, Pune
Department of Paediatrics, KEM Hospital Research Centre, TDH Building 3rd Floor,Sardar Moodliar Road, Rasta Peth-Pune-411011,Maharashtra Pune MAHARASHTRA
9822056174
ashish.bavdekar1@gmail.com
Dr K L Ravi Kumar
Kempegowda Institute of Medical Sciences, Bangalore
Department of Paediatrics, Kempegowda Institute of Medical Sciences, Banashankari 2nd stage, Bangalore -560070, Karnataka Bangalore KARNATAKA
0988022995
klravikumar@gmail.com
Details of Ethics Committee
No of Ethics Committees= 7
Name of Committee
Approval Status
Drug Trial Ethics Committee, Dayanand Medical College and Hospital
Submittted/Under Review
Ethics Committee, Kamalnayan Bajaj Hospital
Submittted/Under Review
IEC, Government Medical College
Submittted/Under Review
Institutional Ethics Committee, Institute of Child Health
Approved
Institutional Ethics Committee, JSS Medical College
Submittted/Under Review
KEM Hospital Research Centre Ethics Committee
Submittted/Under Review
KIMS Institutional Ethics Committee
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: A403||Sepsis due to Streptococcus pneumoniae,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Nil
Nil
Inclusion Criteria
Age From
1.00 Day(s)
Age To
17.00 Year(s)
Gender
Both
Details
• 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
ExclusionCriteria
Details
• Patients with incomplete medical records and non-availability of adequate biological samples as per the Investigator’s discretion
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Serotype distribution of S. pneumoniae in participants
Baseline
Secondary Outcome
Outcome
TimePoints
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
Target Sample Size
Total Sample Size="202" Sample Size from India="202" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
31/10/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
• 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.