| CTRI Number |
CTRI/2024/07/071126 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Retrospective Study Based On Antibiotic Consumption And Its Susceptibility In Neonates |
|
Scientific Title of Study
|
Antibiotic Consumption And Its Susceptibility Pattern In Neonates: A Retrospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Wiona Denita Moras |
| Designation |
Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences ,Paneer, Deralakatte, Mangaluru-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8296493463 |
| Fax |
|
| Email |
wionamoras@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Dept. of Pharmacy Practice
NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte, Mangaluru-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udayv@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Pavaman Sindgikar |
| Designation |
Professor and Head |
| Affiliation |
Justice KS Hegde Charitable Hospital |
| Address |
Dept. of Paediatrics
Justice KS Hegde Charitable Hospital
K.S. Hegde Medical Academy
Deralakatte, Mangaluru – 575 018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9741511245 |
| Fax |
|
| Email |
seemapavaman@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, NITTE(Deemed to be University),Paneer,Deralakatte, Mangaluru, Karnataka 575018
|
| Justice KS Hegde Charitable Hospital,Deralakatte, Mangaluru, Karnataka 575018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Seema Pavaman Sindgikar |
Justice K S Hegde Charitable hospital |
Department of Pediatrics
Justice KS Hegde Charitable Hospital, Deralakatte, Mangaluru 575018 Karnataka
Dakshina Kannada
KARNATAKA |
9741511245
seemapavaman@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A408||Other streptococcal sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Participants less than 1 month of age who have been admitted in NICU for the following diagnosis,
receiving IV antibiotics for a minimum of 5 days
Suspected neonatal sepsis
Proven or confirmed neonatal sepsis
Pneumonia
Meningitis
Necrotizing enterocolitis
Surgical site infection
Osteomyelitis
Septic arthritis
Umbilical sepsis
All participants who were treated in the last 2 years (2020- 2021)in Justice KS Hedge Hospital.
Participants with clear information and response to antibiotic therapy will be incorporated into
the study |
|
| ExclusionCriteria |
| Details |
Participants who were discharged against medical advice.
Participants whose culture sensitivity test is not done |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Calculate Antimicrobial Consumption using AMC Tool |
8 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Choice of empirical antibiotic therapy initiated in participants |
8 months |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
03/08/2024 |
| 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="0"
Months="8"
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
|
INTRODUCTION
The neonatal period is the first 4 weeks of a child’s life. Neonates are most susceptible to infectious agents due to the low immune system. Neonatal sepsis is one of the most common causes of neonatal mortality and morbidity. Antibiotics are the commonest drugs used in the NICU. Virtually all extremely low birth weight infants receive antibiotics and for all other birth weight groups admitted to the NICU, majority are treated with antibiotics AMC Tool computes antimicrobial consumption data provided as numbers of packages into numbers of DDD using the ATC/DDD index.
OBJECTIVE
To calculate antimicrobial consumption using AMC (antimicrobial consumption) tool
To analyze the antibiotic susceptibility patterns among neonates.
JUSTIFICATION OF THE STUDY
There is an increase in antibiotic resistance because of the improper culture sensitivity test and if the culture sensitivity test is not done properly there will be an impact on neonates which might lead to the failure of treatment, morbidity mortality. AMC tool will help to evaluate the consumption and resistance pattern in neonates in an effective way. In developing nations, bloodstream infections are a leading cause of illness in paediatric patients. However, there is an increase in both the amount of antimicrobial medication resistance and the appearance of causative agents. METHODOLOGY
A retrospective study in neonates who had consumed antibiotics and who have attended the inpatient units in paediatrics for the last 3 years at Justice K.S Hedge charitable hospital in age group less than 1 month along with their culture sensitivity report will be enrolled in the study. A structured data collection form using AMC tool was used to collect data. Based on inclusion criteria Neonates <1 month of age who have been admitted in NICU for the following diagnosis such as Suspected neonatal sepsis, Proven or confirmed neonatal sepsis, Pneumonia, Meningitis, Necrotizing enterocolitis, Surgical site infection, Osteomyelitis, Septic arthritis, Umbilical sepsis, along with their clear information and response to antibiotic therapy will be incorporated into the study
STATISTICAL ANALYSIS
The data will be entered in Ms excel and analysed using SPSS [V29.0]. The quantitative data will be expressed as mean ± SD and qualitative data using frequency [%]. Data will also be represented graphs or diagrams.
OUTCOME MEASURES
This study will give overview of bacteriological profile, resistance pattern, sensitivity pattern in neonate patients and choice of empirical antibiotic therapy initiated in neonates.
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