"Surveillance of Carbapenem Resistant Enterobacterales in two intensive care units in India
- Conditions
- Infectious gastroenteritis and colitis, unspecified, (2) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms,
- Registration Number
- CTRI/2022/08/045131
- Lead Sponsor
- Washington University School of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 300
Consenting patients admitted to selected ICUs.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Amrita Institute of Medical Sciences
🇮🇳Ernakulam, KERALA, India
Amrita Institute of Medical Sciences🇮🇳Ernakulam, KERALA, IndiaSanjeev SinghPrincipal investigatorsanjeevksingh@aims.amrita.edu