| CTRI Number |
CTRI/2025/12/098968 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study evaluates children aged above 28 days to 14 years who were started on empirical antibiotics in view of suspected infection and later assessed for microbiological confirmation,clinical outcomes including septic shock. |
|
Scientific Title of Study
|
Adverse Clinical Outcomes Across Low Intermediate And High Phoenix Sepsis Score Risk Groups In Children With Suspected Infection - A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TP253123890 - 14/8/25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RENJINI M R |
| Designation |
DNB RESIDENT IN PEDIATRICS |
| Affiliation |
KIMS HEALTH TRIVANDRUM |
| Address |
DNB resident
Department of pediatrics
Kerala Institute of Medical Sciences
P B No 1
Anayara P O
Trivandrum
Kerala-695029
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9400535419 |
| Fax |
|
| Email |
renjinimr699@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DIVAKAR JOSE R R |
| Designation |
ASSOCIATE CONSULTANT PEDIATRIC CRITICAL CARE |
| Affiliation |
KIMS HEALTH TRIVANDRUM |
| Address |
Associate consultant pediatric critical care ( coguide)
Department of pediatrics
Kerala Institute of Medical Sciences, P B No.1, Anayara P O, Trivandrum, Kerala-695029
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9487461159 |
| Fax |
|
| Email |
drdivakarjoserr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RENJINI M R |
| Designation |
DNB PEDIATRIC RESIDENT |
| Affiliation |
KIMS HEALTH TRIVANDRUM |
| Address |
DNB pediatric resident
Department of pedaitrics
Kerala Institute of Medical Sciences, P B No.1, Anayara P O, Trivandrum, Kerala-695029
Thiruvananthapuram
KERALA
695029
India |
| Phone |
9400535419 |
| Fax |
|
| Email |
renjinimr699@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KIMS HEALTH TRIVANDRUM |
| Address |
Kerala Institute of Medical Sciences, P B No.1, Anayara P O, Trivandrum, Kerala-695029 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR RENJINI M R |
KIMS HEALTH TRIVANDRUM |
Department of pediatrics
Kerala Institute of Medical Sciences, P B No.1, Anayara P O, Trivandrum, Kerala-695029
Thiruvananthapuram
KERALA |
09400535419
renjinimr699@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
29.00 Day(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Any Child With Clinically Suspected Infection
A)Started On Empirical Antibiotic Therapy
And Or
B)Blood Culture PCR Done From Sterile Site (Blood CSF Pleural Fluid Peritoneal Fluid Bone Joint Fluid) |
|
| ExclusionCriteria |
| Details |
Children On DNR Or EOLC Care
Children Receiving Prophylactic Antibiotics Post Surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rate of adverse clinical outcome defined as the occurrence of any one of the following
Death
Invasive mechanical ventilation
Renal replacement therapy
Hospital stay more than 10 days |
Rate of adverse clinical outcome defined as the occurrence of any one of the following
Death
Invasive mechanical ventilation
Renal replacement therapy
Hospital stay more than 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of children with confirmed microbiological diagnosis among who receive antimicrobial drugs. |
1 week |
| Proportion of children with septic shock as per phoenix criteria among study population & their clinical outcomes |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
20/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
phoenix sepsis score will be applied using worst recorded parameters within first 24 hours to identify sepsis Based on the score they will be categorized into low intermediate and high risk groups clinical outcomes in each group will subsequently be compared understanding in this area can highlight discrepancies improve sepsis recognition and optimize resource use |