| CTRI Number |
CTRI/2024/08/073091 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of mathematical tool for predicting probable outcome in patients with severe bacterial infections in paediatric ICU |
|
Scientific Title of Study
|
Development of prognostic model for paediatric patients with Gram-negative infections undergoing antibiotic therapy in paediatric ICU |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishnakumar Athavil |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room no:16, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education,Madhav Nagar, Manipal
Udupi
KARNATAKA
-576104
India |
| Phone |
9633906201 |
| Fax |
|
| Email |
krishnakumar.mcopsmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VijayanarayanaK |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room no:16, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education,Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448255124 |
| Fax |
|
| Email |
vijayanarayana.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr VijayanarayanaK |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room no:16, Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education,Madhav Nagar, Manipal
KARNATAKA
576104
India |
| Phone |
9448255124 |
| Fax |
|
| Email |
vijayanarayana.k@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital and Kasturba Medical College, Manipal. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suneel C Mundkur |
Kasturba Hospital |
Department of pediatrics, pediatric intensive care unit, room no 1, near pediatric triage, second floor, Women and Children block.
Udupi
KARNATAKA |
9845150802
suneel.mundkur@manipal.edu |
| Krishnakumar Athavil |
Kasturba Medical College and Kasturba Hospital |
Department of Pediatrics, Pediatric Intensive Care Unit1, Near pediatric triage, second floor, Women and Children block, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9633906201
krishnakumar.mcopsmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B999||Unspecified infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
28.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
The study includes patients admitted to Paediatric ICU with Gram-negative
infections, aged between 28 days and 18 years, and patients with a creatinine clearance (ClCr) above
50mL/min and receiving antibiotics Inj. Ceftriaxone and Inj. Amikacin either alone or in combinations for
over 48 hours |
|
| ExclusionCriteria |
| Details |
The patients undergoing treatment with extracorporeal membrane oxygenation
(ECMO) or renal replacement therapy (RRT). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A prognostic model will be developed for predicting outcome of pediatric patients with Gram-negative infections |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Estimated serum antibiotic levels and antibiotic susceptibility profiles correlating with clinical outcomes, will help clinicians optimise antibiotic regimens for pediatric patients. |
3 years |
|
|
Target Sample Size
|
Total Sample Size="271"
Sample Size from India="271"
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)
|
01/10/2024 |
| 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="3"
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
|
The prospective observational study will be carried out at the Pediatric intensive care unit of the Department of Pediatrics, Kasturba Hospital, Manipal Karnataka. The study aims to develop a prognostic model for predicting the outcome of patients with Gram-negative infections undergoing antibiotic therapy. the study will include pediatric patients with culture-positive Gram-negative infections undergoing antibiotic therapy for more than 48 hours in the Pediatric ICU. The patients will be followed up till discharge or death. Serum antibiotic levels, estimated for trough and peak levels, and the antibiotic susceptibility profiles will be correlated with clinical outcomes. The patient clinical characteristics and various risk factors for outcome will be identified. Considering serum drug levels, antibiotic susceptibility profiles, and various risk factors identified as prognostic factors, a prognostic model will be developed using logistic regression. Objectives: A. To estimate the serum drug levels of antibiotics used for Gram-negative infections in PICU. B. To correlate antibiotic susceptibility test reports with serum antibiotic levels and clinical outcomes. C. To develop a prognostic model for paediatric patients with Gram-negative infections undergoing antibiotic therapy in paediatric ICU Primary outcome: A prognostic model will be developed for predicting outcome of pediatric patients with Gram-negative infections |