Program of enhanced infection control and prevention (IPC) guided by active and passive surveillance for carbapenem- and colistin-resistant Gram-negative organisms

Not yet recruiting

Conditions: Bacterial infection, unspecified,

Registration Number: CTRI/2022/11/047361

Lead Sponsor: US Centers for Disease Control and Prevention

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 9600

Inclusion Criteria

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.

Exclusion Criteria

Exclusion Criteria â€¢ Species not considered to be of concern for IPC activities â€¢ Age < 12 years â€¢ Patient declines to participate in study activities.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRO, CP-CRO, and CR-CRO per 1,000 patient days.	six monthly
prevalence of CRO, CP-CRO, and CR-CRO colonization at admission.	six monthly
Changes in thefrequency of CRO, CP-CRO, and CR-CRO	six monthly

Secondary Outcome Measures

Name	Time	Method
Change in technical capacity in bacteriology laboratories to detect and characterize CRO, CP-CRO, and CR-CRO	Baseline and endline

Trial Locations

Locations (5): Bharati Vidyapeeth (DTU)Medical College andHospital,Pune
🇮🇳
Pune, MAHARASHTRA, India
BJ Government Medical College
🇮🇳
Pune, MAHARASHTRA, India
Dr. D. Y. Patil Medical College, Hospital & Research Centre
🇮🇳
Pune, MAHARASHTRA, India
Medanta - The Medicity Hospital
🇮🇳
Gurgaon, HARYANA, India
P. D. Hinduja Hospital and Medical Research Centre
🇮🇳
Mumbai, MAHARASHTRA, India
Bharati Vidyapeeth (DTU)Medical College andHospital,Pune
🇮🇳Pune, MAHARASHTRA, India
DrMahadevan Kumar
Principal investigator
9423155569
mahadevan.kumar@bharatividyapeeth.edu