| CTRI Number |
CTRI/2024/09/073225 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Ambispective |
| Study Design |
Other |
|
Public Title of Study
|
Cost-effectiveness, utilization pattern and adverse effect of anti-tuberculosis medicines (Bedaquiline and Delamanid) in children and adolescent multi drug-resistant patients. |
|
Scientific Title of Study
|
Cost-effectiveness, drug utilization study and safety of bedaquiline and delamanid based regimen in pediatric and adolescent MDR-TB patients in a tertiary care hospital. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patel Jaykumar Rameshbhai |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Surat |
| Address |
Department of Pharmacology, Government Medical College, New
Civil Hospital Campus, Majura Gate, Surat
Surat
GUJARAT
395001
India |
| Phone |
7046382151 |
| Fax |
|
| Email |
jayrpatel0054@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetna Patel |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Surat |
| Address |
Department of Pharmacology, Government Medical College, New
Civil Hospital Campus, Majura Gate, Surat
Surat
GUJARAT
395001
India |
| Phone |
7990618600 |
| Fax |
|
| Email |
drchetnapatel2012@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Patel Jaykumar Rameshbhai |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Surat |
| Address |
Department of Pharmacology, Government Medical College, New
Civil Hospital Campus, Majura Gate, Surat
Surat
GUJARAT
395001
India |
| Phone |
7046382151 |
| Fax |
|
| Email |
jayrpatel0054@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 22, 1st Floor, Old OPD Building, New Civil Hospital, Majura Gate, Surat 395001
|
|
|
Primary Sponsor
|
| Name |
Patel Jaykumar Rameshbhai |
| Address |
Department of Pharmacology, Government Medical College, New
Civil Hospital, Majura Gate, Surat 395001
|
| Type of Sponsor |
Other [Self] |
|
|
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 Jaykumar Patel |
New Civil Hospital, Surat |
Medical Records Room,
Room no. 22, 1st Floor,
Old OPD Building, New
Civil Hospital, Majura
Gate, Surat 395001
Surat
GUJARAT |
7046382151
jayrpatel0054@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Review Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z870||Personal history of diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Data of confirmed cases of MDR- TB admitted in the respiratory medicine department. |
|
| ExclusionCriteria |
| Details |
a)Case Records with inadequate details
b)Drug resistant TB with people with antiretroviral
therapy (ART)
c)Patients below age of 6 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study the pharmaco-economic variables (cost effectiveness, cost
minimization, cost-utility and cost-benefit)
2. Evaluation of prescription for DUS by WHO prescribing core indicators.
3. Assessment of causality, preventability and severity of adverse drug reactions (ADRs).
• Causality assessment of ADRs by using WHO-UMC criteria
• Severity Assessment by using Modified Hartwig & Siegel Scale
• Preventability of ADRs by using Modified Schumock & Thornton Scale
|
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the correlation of demographic data like socioeconomic status, area, gender and resistance pattern of anti-TB drugs |
1 Year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/09/2024 |
| 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="1"
Months="3"
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
|
An observational study has been designed
as per STROBE guidelines. Institutional Ethics Committee (IEC) approval has been
obtained, and the data collection will be started after the approval of the CTRI.
Data will be collected according to the inclusion and exclusion criteria and
recorded in the case record form. The data will be analyzed for - Pharmacoeconomics study
- Drug utilization study (DUS)
- The assessment of causality,
preventability and severity of ADRs
Pharmacoeconomics study will
be assessed by
1. Cost
effectiveness analysis (CEA): In CEA drug acquisition cost (DTC and
Central Drug Store) will be considered.
Table 1: CEA
|
|
Cost of
therapy
(INR)
|
Effectiveness
(%)
|
CEA
|
|
Regimen
A
|
|
|
|
|
Regimen
B
|
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Regimen
C
|
|
|
|
Total cost of a
treatment option = mean cost per defined daily dosage (DDD) × duration of
therapy
Effectiveness of a treatment option (in
natural unit) = sum of all criterion rating
(where criterion rating =
criterion value × assigned weight)
Table 2: Decision analysis of effectiveness of multi drug
resistant antitubercular drug:
|
|
Regimen A
|
Regimen B
|
Regimen
C
|
|
Criteria
|
Value(%)
|
Assigned weight
|
Criteria rating
|
Value(%)
|
Assigned weight
|
Criteria rating
|
Value
(%)
|
Assigned
weight
|
Criteria
rating
|
|
Efficacy
|
|
|
|
|
|
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|
|
|
|
Tolerability
|
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Frequency
of administration
|
|
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Bioavailability
|
|
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|
|
|
|
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Sum
of criteria rating
(effectiveness)
|
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2. Cost
minimization analysis: Cost minimization analysis measure the
Monetary
value.
3. Cost
utility analysis: Cost utility analysis measure the QALY
(Quality Adjusted Life Year).
4. Cost
benefit analysis: Cost benefit analysis measure the Disability-adjusted
life years (DALYs). Drug utilization study (DUS)
will be carried out by using WHO prescribing core indicators and facility
indicators.
·
WHO prescribing core
indicators:
Ø Average number of medicines prescribed per
encounter
Ø Percentage of medicines prescribed by generic
name
Ø Percentage of encounters with an antibiotic
prescribed
Ø Percentage of encounters with an injection
prescribed
Ø Percentage of medicine prescribed from an
essential medicine list or formulary.
Ø Average drug cost per encounter.
·
Facility indicators:
Ø Availability
of copy of essential drug list or formulary
Ø Availability
of key drugs The assessment of causality,
preventability and severity of ADRs will be done by
using - WHO-UMC causality assessment criteria
- Modified Schumock & Thornton scale
- Modified Hartwig & Seigel scale
Data will be analyzed by descriptive
statistics and appropriate tests with SPSS software’s 20th version (which is
freely available).
|