| CTRI Number |
CTRI/2024/06/068904 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Implementation and Evaluation of an Evidence Based Comprehensive Antimicrobial Stewardship Interventions in Blood Cancer Patients |
|
Scientific Title of Study
|
Implementation and Evaluation of an Evidence Based Comprehensive Antimicrobial Stewardship Interventions in Haematological Malignancy Patients |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avvaru Deepthi |
| Designation |
Research Scholar |
| Affiliation |
Kasturba Medical College |
| Address |
Room number 13, Department of Infectious Diseases, Kasturba Medical College
Udupi
KARNATAKA
576104
India |
| Phone |
9834672662 |
| Fax |
|
| Email |
deepthi.kmcmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muralidhar Varma |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Infectious Diseases, Kasturba Medical College
Udupi
KARNATAKA
576104
India |
| Phone |
9845069639 |
| Fax |
|
| Email |
muralidhar.varma@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muralidhar Varma |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Room number 13, Department of Infectious Diseases, Kasturba Medical College
Udupi
KARNATAKA
576104
India |
| Phone |
9845069639 |
| Fax |
|
| Email |
muralidhar.varma@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi-576104, India |
|
|
Primary Sponsor
|
| Name |
Avvaru Deepthi |
| Address |
Department of Infectious Diseases, Kasturba Medical College, Manipal |
| 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 Muralidhar Varma |
Kasturba Hospital |
Room number 13, Department of Infectious Diseases, Kasturba Medical College, Manipal
Udupi
KARNATAKA |
9845069639
muralidhar.varma@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE and KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| KMC & KH IEC Complete |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C81||Hodgkin lymphoma, (2) ICD-10 Condition: C82||Follicular lymphoma, (3) ICD-10 Condition: C83||Non-follicular lymphoma, (4) ICD-10 Condition: C84||Mature T/NK-cell lymphomas, (5) ICD-10 Condition: C85||Other specified and unspecified types of non-Hodgkin lymphoma, (6) ICD-10 Condition: C86||Other specified types of T/NK-celllymphoma, (7) ICD-10 Condition: C88||Malignant immunoproliferative diseases and certain other B-cell lymphomas, (8) ICD-10 Condition: C90||Multiple myeloma and malignant plasma cell neoplasms, (9) ICD-10 Condition: C91||Lymphoid leukemia, (10) ICD-10 Condition: C92||Myeloid leukemia, (11) ICD-10 Condition: C93||Monocytic leukemia, (12) ICD-10 Condition: C94||Other leukemias of specified celltype, (13) ICD-10 Condition: C95||Leukemia of unspecified cell type, (14) ICD-10 Condition: C96||Other and unspecified malignant neoplasms of lymphoid, hematopoietic and related tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antibiotic policy specific to HM patients |
Developed antibiotic policy will help in improving inappropriateness of antibiotic therapy (for 1 year) |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
All adults ≥18 years of age diagnosed with HM on antibiotic.
Prescribers involved with antibiotic prescription in the treatment of HM patients.
Prescribers involved with antibiotic prescription in the treatment of HM patients, multidisciplinary (AMS) team
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Prescribers not involved with HM patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To optimise antibiotic therapy through Antimicrobial Stewardship Intervention among Haematological Malignancy patients. |
After 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prospective audit & feedback by clinical pharmacist will aid in assessing & reducing potentially inappropriate therapy which will improve outcomes.
|
After 6 months of intervention |
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="6"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Cancer patients in India, exhibit a high prevalence to first line antibiotics. Blood stream infections are commonly reported in patients with haematological malignancies. Data is limited regarding epidemiological and antimicrobial resistance pattern among haematological malignancies patients in India. To avoid unnecessary use of broad-spectrum antimicrobials for unspecified durations, it is strongly advised to implement a risk-based strategy. Prudent utilisation of antimicrobials, monitoring resistance patterns through surveillance and engaging an active multidisciplinary are essential for reducing antimicrobial resistance and clinical outcomes. |