| CTRI Number |
CTRI/2019/08/020938 [Registered on: 28/08/2019] Trial Registered Prospectively |
| Last Modified On: |
04/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on cost of antibiotic therapy |
|
Scientific Title of Study
|
A study to evaluate the implications of cost burden on anti-microbial resistance(AMR) using data analytics techniques. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashant Chandra |
| Designation |
Research Scholar |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room no: 05, Department of Pharmacy Practice, Manipal college of Pharmaceutical Sciences,Kasturba Hospital, Madhav nagar-576104
Udupi
KARNATAKA
576104
India |
| Phone |
08202922403 |
| Fax |
|
| Email |
prashantpharmacy@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh V |
| Designation |
Assistant Professor (Selection Grade) |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room no: 03, Department of Pharmacy Practice, Manipal college of Pharmaceutical Sciences,Kasturba Hospital, Madhav nagar-576104
Udupi
KARNATAKA
576104
India |
| Phone |
08202922403 |
| Fax |
|
| Email |
rajesh.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh V |
| Designation |
Assistant Professor (Selection Grade) |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room no: 03, Department of Pharmacy Practice, Manipal college of Pharmaceutical Sciences,Kasturba Hospital, Madhav nagar-576104
Hassan
KARNATAKA
576104
India |
| Phone |
08202922403 |
| Fax |
|
| Email |
rajesh.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room no: 207,2nd floor, Department of Microbiology Critical care Laboratory, Kasturba hospital, Madhav nagar, Manipal-576104 |
|
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Primary Sponsor
|
| Name |
Not Applicable |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Prashant Chandra |
Kasturba Hospital |
Room no:2, Department of Microbiology, Kasturba Hospital, Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8075575121
prashantpharmacy@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A418||Other specified sepsis, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Both Community acquired and hospital Acquired Infection Patients, Both Gram positive and Gram Negative Infections, Multiple infections and/or multiple site of infections, Direct cost
|
|
| ExclusionCriteria |
| Details |
Incomplete susceptibility data, Incomplete financial data, Indirect cost
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Difference in total spending to treat an infection and length of stay between three groups.
Resistant bacterial species which caused the additional cost burden and LOS in patients.
|
Every 6 months the cost expenditure and length of stay will be analysed using data analytics techniques. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Total antibiotic use and resistance pattern will be observed. |
Every 6 months the pattern of bacterial resistance will be observed. |
|
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Target Sample Size
|
Total Sample Size="1320"
Sample Size from India="1320"
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)
|
02/09/2019 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
The paper will be published in a well reputed scopus indexed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The main objective of the study is to: To study the impact of AMR on attributable cost and length of stay (LOS) in hospitalized patient. To develop predictive model for the outcomes in patients with Antimicrobial resistant infection. To assess the correlation between the antibiotic’s usage and bacterial resistance pattern in a tertiary care hospital setting.Total sample size would be 1320. Patient will be divided into 3 categories: Susceptible, Resistance, and multi-resistant group and the outcome of interest will be compared using various machine learning algorithms.
Currently recruited 142 patients.
|