| CTRI Number |
CTRI/2019/10/021721 [Registered on: 18/10/2019] Trial Registered Prospectively |
| Last Modified On: |
17/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Rate of multidrug resistance to antimicrobial drugs in paediatric neurointensive care patients |
|
Scientific Title of Study
|
A prospective observational cohort study to determine rate of Multidrug resistance to antimicrobial drugs in paediatric neurointensive care patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swapnil Patel |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Neuroanaesthesia Office, 7th floor , CNC, AIIMS
Room 707, Office of Neuroanaesthesia
New Delhi
DELHI
110029
India |
| Phone |
9582086707 |
| Fax |
|
| Email |
swapnil_doc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hemanshu Prabhakar |
| Designation |
Proffesor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
7th floor, CNC, AIIMS
7th floor, CNC , AIIMS
New Delhi
DELHI
110049
India |
| Phone |
9582086707 |
| Fax |
|
| Email |
prabhakaraiims@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Swapnil Patel |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Neuroanesthesia office, 7th floor, CNC, AIIMS
Neuroanesthesia office, 7th floor, CNC, AIIMS
New Delhi
DELHI
110049
India |
| Phone |
9582086707 |
| Fax |
|
| Email |
swapnil_doc@yahoo.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences |
| Address |
Ansari nagar , new delhi |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Swapnil Patel |
AIIMS |
Neurosurgical ICU, First floor, CNC
New Delhi
DELHI |
9582086707
swapnil_doc@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z163||Resistance to other antimicrobialdrugs, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Age:1-18 years
2. All elective and emergency intracranial and spine surgeries |
|
| ExclusionCriteria |
| Details |
1. Age: >18 yrs
2. Non consenting patients
3. Patients with high risk of MDRO colonisation:
antibiotic exposure history (within last 3 months)
presence of underlying diseases,
previous surgery (within last 1 month)
exposure to other MDRO colonized patients,
patients transferred from other facilities known to have a high prevalence of MDRO carriage,
history of recent hospital or nursing home stays |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To determine Rate of Multidrug resistance to antimicrobial drugs |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine organisms and risk factors leading to Multidrug resistance |
One year |
|
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/01/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
INTRODUCTION:The global rise in use of antibiotics has led to development of resistant bacteria and increasing costs in healthcare. 1Paediatric patients are a high risk population subgroup for acquiring Healthcare Associated infections.Our aim is To measure burden of antimicrobial resistance in paediatric neurointensive care patients. MATERIALS &METHODS:This prospective observational cohort study will enroll all operative neurosurgical pediatric patients aged between 1-18 year admitted in neurointensive care unit during one year period after approval from institutional ethics committee. Daily monitoring of risk factors, including devices, mechanical ventilation, laboratory indices, cultures, sensitivities, length of NSICU stay, and their final outcome, either discharge or death, will be recorded.The data collection will be done on a predesigned proforma. The specific HAI-type will be diagnosed according to clinical and laboratory criteria set by Centers for Disease Control and Prevention. Clinical samples for microbiological culture comprise of blood, urine, pus, CSF and endotracheal aspirates and will be sent once infection is suspected according to clinical criteria set by CDC. REVIEW OF LITERATURE:In a prospective study conducted in 2016 by El-Nawawy et al the incidence of Paediatric Intensive care unit-acquired episodes in was found to be 13.63(n=36/264episodes),which was equivalent to15.6 cases/1,000 patient days.
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