| CTRI Number |
CTRI/2025/10/095840 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Development of Antimicrobial Stewardship program in rural hospitals |
|
Scientific Title of Study
|
Development of Customized Antimicrobial Stewardship Program for Rural Hospitals using Hub and Spoke model in districts of West Bengal -a health system implementation research. |
| Trial Acronym |
Hub & Spoke |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debjit Chakraborty |
| Designation |
Scientist E |
| Affiliation |
ICMR - National Institute for Research in Bacterial Infections |
| Address |
Division of Epidemiology, ICMR- NIRBI, NIRBI -II Building, Room No -106
P-33, CIT Road, Scheme XM, Beliaghata, Kolkata -700010
Kolkata
WEST BENGAL
700010
India |
| Phone |
08296875975 |
| Fax |
|
| Email |
drdebjitepi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debjit Chakraborty |
| Designation |
Scientist E |
| Affiliation |
ICMR - National Institute for Research in Bacterial Infections |
| Address |
Division of Epidemiology, ICMR- NIRBI, NIRBI -II building, Room No -106
P-33, CIT Road, Scheme XM, Beliaghata, Kolkata -700010
Kolkata
WEST BENGAL
700010
India |
| Phone |
08296875975 |
| Fax |
|
| Email |
drdebjitepi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debjit Chakraborty |
| Designation |
Scientist E |
| Affiliation |
ICMR - National Institute for Research in Bacterial Infections |
| Address |
Division of Epidemiology, ICMR- NIRBI, NIRBI- II Building, Room No. 106
P-33, CIT Road, Scheme XM, Beliaghata, Kolkata -700010
Kolkata
WEST BENGAL
700010
India |
| Phone |
08296875975 |
| Fax |
|
| Email |
drdebjitepi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research · V. Ramalingaswami Bhawan, P.O. Box No. 4911 · Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911 · Ansari Nagar, New Delhi - 110029, |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Debjit Chakraborty |
ICMR – National Institute for Research in Bacterial Infections |
Division of Epidemiology, NIRBI -II Building, Room No 106, P-33, Scheme XM, CIT Road, Beliaghata, Kolkata – 700010
Kolkata
WEST BENGAL |
08296875975
drdebjitepi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC BMHR, ICMR NIRBI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B95-B97||Bacterial and viral infectious agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Customized Antimicrobial Stewardship intervention in rural hospitals |
Package of Intervention:
1.Formation of a RH level AMSP Committee
2.Periodic training of Physician, Nurses, Pharmacist, LT facilitated by Medical College on Rational Antimicrobial and other AMSP indicators
3.Period assessment of Antibiotic Consumption and culture of samples (urine,stool, blood, throat swab, NP Swab, sputum) for Local Antibiogram of common pathogen.
4.Point of Care test- Urine Dip stick test / Typhi dot (where applicable)
5.Making Guidelines in easy calender or tabloid format
6.Periodic prescription (OPD, IPD) evaluation guidance by AMSP Committee and a Medical College based Consensus Committee
The healthcare providers in the intervention rural hospitals will be given the AMSP intervention mentioned. Doctors will be given training on rational antibiotic prescription and prescription audit mechanism.
Nurses will be trained on antibiotic time out, sample sending and infection control practices.
Lab Technicians will be trained on sample collection, POCT test and sending samples for cultures in proper condition.
Pharmacist will be involved in maintaining antibiotic consumption. |
| Comparator Agent |
Standard care |
Standard care at rural hospital. Data (Prescription) will be collected from control arm rural hospitals for assessing standard practices in antibiotic uses and infection control for common infections by doctors |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Diseases as follows: Acute Undifferentiated Febrile illness, Urinary Tract Infection, Acute Respiratory Infections, Acute Diarrhoeal Disaeses |
|
| ExclusionCriteria |
| Details |
Unable or Unwilling to provide consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Indicators:
. 1.Antibiotic prescribing rate (APR) - number of prescriptions that included at least one antibiotic/total number of prescriptions × 100
2. Multiple antibiotics prescribing rate (MPR ) - number of prescriptions that included at least two antibiotics /total number of prescriptions that included at least one antibiotic × 100.
3.Parenteral antibiotics prescribing rate (PAPR) - number of prescriptions that included at one injectable antibiotic /total number of prescriptions that included at least one antibiotic × 100.
(European Surveillance of Antibiotic Consumption)
4.Antibiotic prescribed as per WHO AWaRe classification - Access to Watch Ratio
|
Pre and Post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The difference in DDD per 1000 inpatient days (ATC-DDD) |
Pre and Post intervention |
|
|
Target Sample Size
|
Total Sample Size="3132"
Sample Size from India="3132"
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)
|
03/11/2025 |
| 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)
|
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
|
Rationale: Primary care health facilities do not have microbiological diagnostic services and neither any antimicrobial stewardship programs (AMSP) yet a huge proportion of rural population takes empirical antibiotic from these settings. Novelty: Novelty lies in its approach to establish customized AMSP in Rural Hospitals by linking it to District Medical Colleges through Hub and Spoke Model. Objectives: Primary objectives: 1. To generate the baseline data in terms of key AMSP indicators in selected rural hospitals (RH) of two districts of West Bengal 2. To develop and implement customized AMSP intervention in selected RH through the Hub and Spoke Model 3. To evaluate the effectiveness of customized AMSP intervention in RH against control Arm (existing system in RH) Secondary objective: 1 To identify barriers & facilitators of customized AMSP intervention through Hub and Spoke Model. Methods: In this Health System Implementation Research through two arm cluster randomized intervention, 6 Rural Hospitals will be selected from 2 districts each (Total 12 RH). 3 RH in each districts will be termed as intervention arm and linked to Medical Colleges and remaining will be control arm.(Standard Practice). Package of AMSP Intervention will include formulation of committee, periodic training of Physician, Nurses, culture and antibiogram, use of point of care test etc. Prescriptions will be evaluated pre and post intervention (1 year) for its effectiveness in terms rational antibiotic prescription indicators. Expected outcome: 1. Determining the effectiveness of customized AMSP interventions through Hub and Spoke model for rationalizing antibiotic usage in primary care settings. |