Barrier protection to lower transmission and infection rates with Gram-negative bacteria inpreterm childre

Not Applicable

• Conditions: Colonization / Transmission of MDRO (Multi drug resistant organisms); Bacterial sepsis of newborn; P36

• Registration Number: DRKS00019103
• Lead Sponsor: IVERSITÄTSKLINIKUM WÜRZBURG, Kinderklinik und Poliklinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-16
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Inclusion of an entire neonatal unit. Analyses of microbiotic Screening-data, not Patient specific data

Exclusion Criteria

Exclusion of a Center in case of missing microbiotic surveillance (KRINKÒ)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint is the rate of blood kulture pos. infections with gram neg. bacteria in all term- and preterm infants, in wich a Screening was performed (non- inferiority).<br>This endpoint is defined clinically along NEO-KISS-criteria (two signs of Sepsis + one laboratory sign of Inflammation (e.g. CrP >10mg/dl) and proof of a gram neg. pathogen in bood culture)

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are i.a. the transmission rate of 2_MRGN bacteria. Transmission is postulated if two children are colonized are infected with the same bacteria (with same resistance spectrum) in spaciotemporal connection. <br>Other secondary endpoints are the transmissionrate of other bacteria included in the KRINKO-Screening, rate of all blood-stream infections and clinical infections, number of antibiotic cycles, use of antibiotics of the last resort (e.g. carbapenemes) and consumption rate of antibiotics and desinfectants.