| CTRI Number |
CTRI/2022/08/045131 [Registered on: 31/08/2022] Trial Registered Prospectively |
| Last Modified On: |
31/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
"Surveillance of Carbapenem Resistant Enterobacterales in two intensive care units in India |
|
Scientific Title of Study
|
Carbapenem Resistant Enterobacterales Surveillance in Two Intensive Care
Units in India (CRESCENT Study)
|
| Trial Acronym |
CRESCENT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjeev Singh |
| Designation |
Medical Director |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
MD office
Dept of Medical Administration
Amrita Institute of Medical Sciences
Sector 88
Faridabad
HARYANA
682041
India |
| Phone |
682041 |
| Fax |
|
| Email |
sanjeevksingh@aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeev Singh |
| Designation |
Medical Director |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
MD Office,
Department of Medical Administration,
Amrita Institute of Medical Sciences
Sector 88
Faridabad
HARYANA
121002
India |
| Phone |
|
| Fax |
|
| Email |
sanjeevksingh@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sanjeev Singh |
| Designation |
Medical Director |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
MD Office,
Department of Medical Administration,
Amrita Institute of Medical Sciences
Sector 88
Faridabad
HARYANA
682041
India |
| Phone |
|
| Fax |
|
| Email |
sanjeevksingh@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Washington University School of Medicine, 660 S Euclid Ave, St. Louis, MO 63110, United States |
|
|
Primary Sponsor
|
| Name |
Washington University School of Medicine |
| Address |
660 S Euclid Ave, St. Louis, MO 63110, United States |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sanjeev Singh |
Amrita Institute of Medical Sciences |
Room No. 10,
Department of Infection Control and Epidemiology,
AIMS P.O,
Ponekkara
Ernakulam
KERALA |
0484-2852020
sanjeevksingh@aims.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A09||Infectious gastroenteritis and colitis, unspecified, (2) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IPC based intervention |
The baseline data collected on CRE rate ratios and prevalence would be assessed to design and formulate an IPC based intervention for a 3 month duration |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Consenting patients admitted to selected ICUs |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimates of admission CRE prevalence and CRE acquisition rates in the study ICUs using SCS. |
At 24-48 hours of ICU admission, every week, at ICU discharge or death or until colonized with CRE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Risk factors associated with CRE colonization on admission and CRE acquisition during ICU stay.
3. Estimates of CRE prevalence detected by routine clinical cultures versus surveillance cultures.
4. Estimates of admission and discharge CRE rate ratios in the ICUs using LCS strategy that are comparable to SCS strategy.
5. Clinical risk factor and clinical culture information role in augmenting the LCS strategy.
6. Baseline infection prevention practices in study ICUs focusing on environmental cleaning practices of immediate patient environment, hand hygiene practice and contact isolation precaution practices for CRE positive patients.
7. CRE incidence rate ratios using the optimal LCS strategy before and after the infection prevention intervention
|
3,4,7 : At 24-48 hours of ICU admission, every week, at ICU discharge or death or until colonized with CRE
2,5,6 : derived post data collection and analysis
|
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/09/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Enterobacterales are a group of different types of bacteria among which some bacteria can cause serious and deadly infections in healthcare settings. When Enterobacterales develop resistance to an important group of antibiotics called carbapenems, they are called carbapenem-resistant Enterobacterales (CRE). CRE are a major concern for patients in healthcare settings because they are resistant to carbapenem antibiotics, which are considered the last line of defense to treat multidrug-resistant bacterial infections. Due to high levels of antibiotic resistance in CRE in a number of regions and healthcare settings, treatment options are often limited to more toxic and less effective antibiotics and thus, CRE infections are associated with high mortality worldwide. Barriers in healthcare access, diagnostic testing, and therapeutic options experienced by low- and middle-income countries (LMICs) make them more vulnerable to adverse outcomes from CRE infections. India is a LMIC where CRE is highly prevalent in healthcare facilities. In 2019 national surveillance data from 21 Indian hospitals noted that 35% of Enterobacterales isolated from clinical specimens (excluding urine and feces) were carbapenem resistant. Despite this high burden of CRE, studies examining CRE prevalence on admission and subsequent acquisition in hospitals in India are extremely limited. An important aspect of developing surveillance systems for CRE colonization within a hospital is having actionable data to prevent the spread of infection to other vulnerable patients. However, cost-effective methods for CRE surveillance in resource-limited settings has been identified as a major gap. Active surveillance which involves admission and weekly cultures for intestinal CRE colonization (presence of bacteria in the digestive tract without causing disease) among hospitalized patients is the preferred method to monitor CRE transmission. However, this method is highly resource intensive, making it impractical in LMICs. The World Health Organization (WHO) recognizes that the cost of CRE surveillance is a major barrier toward implementing their guidance to prevent carbapenem resistant bacterial infections in health care facilities.
In this study we will examine the utility and feasibility of a low intensity (less resource intensive) active CRE surveillance strategy to guide infection prevention practices in two intensive care units (ICUs) in a tertiary care hospital in India. |