| CTRI Number |
CTRI/2024/01/061498 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Surveillance network for infections contracted in health settings |
|
Scientific Title of Study
|
A Clinically-Oriented Antimicrobial Resistance Surveillance Network for Healthcare-associated infections |
| Trial Acronym |
ACORN-HAI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Lalit Gupta |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002
New Delhi
DELHI
110002
India |
| Phone |
9868092739 |
| Fax |
|
| Email |
lalit.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vivekanand Jha |
| Designation |
Executive Director |
| Affiliation |
George Institute for Global Health |
| Address |
308, Third Floor, Elegance Tower, Plot No 8, Jasola District Centre,
New Delhi, 110025
DELHI
110025
India |
| Phone |
01141588091 |
| Fax |
|
| Email |
vjha@georgeinstitute.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Bathla |
| Designation |
Project Manager |
| Affiliation |
George Institute for Global Health |
| Address |
308, Third Floor, Elegance Tower, Plot No 8, Jasola District Centre,
New Delhi, 110025
New Delhi
DELHI
110025
India |
| Phone |
9886926282 |
| Fax |
|
| Email |
nbathla@georgeinstitute.org.in |
|
|
Source of Monetary or Material Support
|
| George Institute for Global Health, Australia |
|
|
Primary Sponsor
|
| Name |
The George Institute for Global Health |
| Address |
Level 5/1 King St, Newtown NSW 2042, Australia |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National University of Singapore |
12 Science Drive 2
Singapore 119077 |
|
|
Countries of Recruitment
|
India
Bangladesh
Cambodia
Indonesia
Malaysia
Mongolia
Nepal
Pakistan
Philippines
Singapore
Sri Lanka
Thailand
Viet Nam |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rajat Agarawal |
Fortis Escorts Heart Institute |
Okhla road, Sukhdev Vihar Metro Station
New Delhi
DELHI |
9818851504
rajat.agarawal@fortishealthcare.com |
| Lalit Gupta |
Maulana Azad Medical College |
Department of Anaesthesia
3rd Floor, BL Taneja Block,
Maulana Azad Medical College,
New Delhi 110002
New Delhi
DELHI |
9868092739
lalit.doc@gmail.com |
| N Lakshmi Priya |
Medway Hospitals |
No 119, Dr Natesan Rd, Jagadambal Colony, Gokulam Colony, Triplicane, Chennai
Chennai
TAMIL NADU |
9840415245
drpriyamicro@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medway Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J95||Intraoperative and postproceduralcomplications and disorders of respiratory system, not elsewhere classified, (2) ICD-10 Condition: Y95||Nosocomial condition, (3) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
N/A |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Healthcare-associated bloodstream infection
1) Prescription/commencement of an intravenous antibiotic AND
2) Positive growth of bacterial or Candida spp pathogen(s) identified from blood specimen(s) taken on or after day 3 of admission (Day 1 refers to the day of admission), or within 3 months of significant healthcare exposure; AND
3) Bacterial pathogen(s) in the blood specimen(s) satisfies either of the following:
i) one or more non-common commensal bacterial pathogen(s) identified from one or more blood specimens obtained by a culture; OR
ii) the same common commensal bacterial pathogen identified from two or more blood specimens collected on separate occasions
Ventilator-associated pneumonia
1) Clinical suspicion of VAP; AND
2) Prescription/commencement of an intravenous antibiotic; AND
3) Positive growth of bacterial pathogen(s) identified from respiratory specimen(s) taken on or after day 3 of ventilation.
|
|
| ExclusionCriteria |
| Details |
Healthcare-associated bloodstream infection
Patient who has positive growth of organisms belonging to the following genera which are typically causes of community-associated infections and are rarely or are not known to be causes of healthcare-associated infections, or associated with severe immune suppression:
a) Burkholderia pseudomallei,
b) Brucella spp, including but not limited to, B. melitensis, B. abortus, B. suis, B. canis,
c) Campylobacter, Salmonella, Shigella, Listeria, Vibrio and Yersinia.
Ventilator-associated pneumonia
Patient who has positive growth of organisms belonging to the following genera which are typically causes of community-associated infections and/or are rarely or are not known to be causes of healthcare-associated infections:
a) Streptococcus pneumoniae, Streptococcus suis, Haemophilus influenzae,
b) Burkholderia pseudomallei,
c) Coagulase-negative staphylococci,
d) Talaromyces marneffei,
e) Mycobacterium Tuberculosis,
f) Rapidly growing Mycobacteria, including but not limited to, M. mucogenicum, M. fortuitum, M. abscessus, M. chelonae, M. neoaurum
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence & prevalence of multidrug resistant organisms (MDRO) in HA-BSI or VAP quantified in terms of i) hospitalisation, ii) patient bed-days & iii) microbiology cultures |
Onset of clinical syndrome is on or after day 3 of hospital admission, or within 3 months of significant healthcare exposure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of disease (requirement for intensive care, duration of hospitalisation, functional status at discharge, mortality), types of antibiotic treatment |
28 days from onset of the last infection episode |
Attributable mortality of HA-BSI or VAP caused by MDROs versus susceptible organisms or MDROs of different resistance patterns
All-cause mortality of HA-BSI or VAP
|
28 days from onset of the last infection episode |
| Bacterial species & phenotypic resistance patterns across the study sites from various geographical regions over the study period. |
Over the study period |
| Genomic characteristics in terms of bacterial strains/clones, resistance genes across the study sites from various geographical regions |
Over the study period |
|
|
Target Sample Size
|
Total Sample Size="15000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
09/06/2022 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A Clinically-Oriented Antimicrobial Resistance
Surveillance Network (ACORN) is
a large-scale multicentre study which expands on the WHO Global Antimicrobial
Resistance Surveillance System to estimate syndromic and pathogen outcomes
along with associated health economic costs. It aims to implement an efficient
clinically-oriented AMR surveillance system, incorporated as part of routine
workflow in hospitals in low- and middle-income country settings (LMICs). LMICs
hold the highest burdens of AMR and are responsible for the increasing trend in
antibiotic consumption globally.High-quality patient-level surveillance data from LMICs are necessary to
determine the impact of AMR, enable evaluation of interventions, inform policy
decisions on resource allocation, and drive research priorities. The ACORN study
involves various clinical units including intensive care units (ICUs) at each
site. Patients with community-acquired infections are expected to form the
majority of the enrolment.
Implementation of a robust surveillance network for HAIs
caused by MDROs is the necessary first step towards designing infection
prevention and control policies, guiding resource allocation, and motivating
novel treatment therapy clinical trials. A focus on severe HAIs with the
highest health and economic consequences will align the interests and
expectations from various stakeholders including patients, clinicians, health
ministries and pharmaceutical industry. Such data will engage all parties to
direct a concerted effort to tackle the urgent issues in AMR. This is a large-scale multicentre
study for surveillance of HA-BSI and VAP, with a focus on LMICs. |