Surveillance network for infections contracted in health settings

Not Applicable

• Conditions: Health Condition 1: J95- Intraoperative and postproceduralcomplications and disorders of respiratory system, not elsewhere classifiedHealth Condition 2: Y95- Nosocomial conditionHealth Condition 3: A419- Sepsis, unspecified organism

• Registration Number: CTRI/2024/01/061498
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence & prevalence of multidrug resistant organisms (MDRO) in HA-BSI or VAP quantified in terms of i) hospitalisation, ii) patient bed-days & iii) microbiology culturesTimepoint: Onset of clinical syndrome is on or after day 3 of hospital admission, or within 3 months of significant healthcare exposure.

Secondary Outcome Measures

Name	Time	Method
Attributable mortality of HA-BSI or VAP caused by MDROs versus susceptible organisms or MDROs of different resistance patterns <br/ ><br> <br/ ><br>All-cause mortality of HA-BSI or VAP <br/ ><br>Timepoint: 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.Timepoint: Over the study period;Genomic characteristics in terms of bacterial strains/clones, resistance genes across the study sites from various geographical regionsTimepoint: Over the study period;Severity of disease (requirement for intensive care, duration of hospitalisation, functional status at discharge, mortality), types of antibiotic treatmentTimepoint: 28 days from onset of the last infection episode