| CTRI Number |
CTRI/2022/11/047361 [Registered on: 16/11/2022] Trial Registered Prospectively |
| Last Modified On: |
31/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational cohort study and quasi-experimental study |
| Study Design |
Other |
|
Public Title of Study
|
Program of enhanced infection control and prevention (IPC) guided by active and passive surveillance for carbapenem- and colistin-resistant Gram-negative organisms |
|
Scientific Title of Study
|
Global Action in Healthcare Network (GAIHN) - Antimicrobial Resistance, India, Enhanced infection control and prevention driven by targeted surveillance |
| Trial Acronym |
GAIHN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShaoli Basu |
| Designation |
Associate Consultant |
| Affiliation |
P. D. Hinduja Hospital and Medical Research Centre |
| Address |
P. D. Hinduja Hospital and Medical Research Centre
Veer Savarkar Marg, Mahim
Mumbai
Veer Savarkar Marg, Mahim
Mumbai,400016
Mumbai
MAHARASHTRA
400016,
India |
| Phone |
9819177726 |
| Fax |
|
| Email |
dr_shaoli.basu@hindujahospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShaoli Basu |
| Designation |
Associate Consultant |
| Affiliation |
P. D. Hinduja Hospital and Medical Research Centre |
| Address |
P. D. Hinduja Hospital and Medical Research Centre
Veer Savarkar Marg, Mahim
Mumbai
Veer Savarkar Marg, Mahim
Mumbai,400016
MAHARASHTRA
400016,
India |
| Phone |
9819177726 |
| Fax |
|
| Email |
dr_shaoli.basu@hindujahospital.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShaoli Basu |
| Designation |
Associate Consultant |
| Affiliation |
P. D. Hinduja Hospital and Medical Research Centre |
| Address |
P. D. Hinduja Hospital and Medical Research Centre
Veer Savarkar Marg, Mahim
Mumbai
Veer Savarkar Marg, Mahim
Mumbai,400016
MAHARASHTRA
400016,
India |
| Phone |
9819177726 |
| Fax |
|
| Email |
dr_shaoli.basu@hindujahospital.com |
|
|
Source of Monetary or Material Support
|
| US Centers for Disease Control and Prevention (US CDC) |
|
|
Primary Sponsor
|
| Name |
US Centers for Disease Control and Prevention |
| Address |
USA |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMahadevan Kumar |
Bharati Vidyapeeth (DTU)Medical College andHospital,Pune |
Pune-Satara Rd, Dhankawadi
Pune, 411043
Pune
MAHARASHTRA |
9423155569
mahadevan.kumar@bharatividyapeeth.edu |
| DrRajesh Karyakarte |
BJ Government Medical College |
Jai Prakash Narayan Road
Pune, 411001
Pune
MAHARASHTRA |
8999903678
karyakarte@hotmail.com |
| DrShahzad Mirza |
Dr. D. Y. Patil Medical College, Hospital & Research Centre |
Sant Tukaram Nagar
Pimpri-Chinchwad, 411018
Pune
MAHARASHTRA |
7507372372
shahzad.mirza@dpu.edu.in |
| DrSmita Sarma |
Medanta - The Medicity Hospital |
CH Baktawar Singh Road, Sector 38, Gurugram, Haryana 122001
Gurgaon
HARYANA |
9868723089
smita.sarma@medanta.org |
| DrShaoli Basu |
P. D. Hinduja Hospital and Medical Research Centre |
Veer Savarkar Marg, Mahim
Mumbai, 400016
Mumbai
MAHARASHTRA |
9819177726
dr_shaoli.basu@hindujahospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Medical College Institutional Ethics Committee |
Approved |
| Ethics Committee BJ Medical College and Sassoon General Hospital |
Approved |
| Ethics Committee Dr.D Y Patil Vidyapeeth Pune |
Approved |
| P. D. Hinduja Hospital and Medical Research Centre,Institutional Ethics Committee |
Approved |
| The Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Component 1 (passive surveillance)
Passive surveillance will occur for cultures sent from designated wards. All GN isolates found to be CRO by local standard of care AST may be included.
Component 2 (active surveillance)
Patients will be considered for inclusion in active surveillance who are identified as part of a contact investigation for an index case of a critical CRO or possible nosocomial transmission event or are admitted to a ward designated for universal active surveillance.
Component 3 (case investigation):Patients who have an isolate that is a critical CRO (rare or novel resistance mechanism or resistance to treatment) or identified as being part of possible nosocomial transmission will be included. Inpatient contacts identified through case investigation will be included.
Component 4 (enhanced IPC)
Individual patients will not be included in enhanced IPC. Wards selected for enhanced IPC will include ICUs and wards where critical CRO detection or nosocomial transmission is occurring. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
• Species not considered to be of concern for IPC activities
• Age < 12 years
• Patient declines to participate in study activities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
CRO, CP-CRO, and CR-CRO per 1,000 patient days.
prevalence of CRO, CP-CRO, and CR-CRO colonization at admission.
Changes in thefrequency of CRO, CP-CRO, and CR-CRO |
six monthly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in technical capacity in bacteriology laboratories to detect and characterize CRO, CP-CRO, and CR-CRO |
Baseline and endline |
|
|
Target Sample Size
|
Total Sample Size="9600"
Sample Size from India="9600"
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)
|
02/01/2023 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Purpose of the study is to implement a program of enhanced infection control and prevention guided by active and passive surveillance for carbapenem and colistin resistant Gram-negative organism. |