Hospital Microbial Ecology Follow the Introduction of Ertapenem and Other Newly Introduced Antibiotic Over Time

Infectious Diseases Clinical Trial

Official title: The Impact on the Hospital's Microbial Ecology Follow the Introduction of Ertapenem and Other Newly Introduced Antibiotic, Using Antibiotic Utilization and Hospital Susceptibility Data Over Time

Status Active, not recruiting

Clinical Trial Summary

This is a retrospective, multicentre, observational study to assess the trends in antibiotic utilization and hospital ecology with respect to susceptibility patterns of selected bacterial isolates to the utilized antibiotics.

Clinical Trial Description

This is a retrospective, multicentre, observational study to assess the trends in antibiotic utilization and hospital ecology with respect to susceptibility patterns of selected bacterial isolates to the utilized antibiotics.

There will be two sets of data collected: Hospital acquired infection (only the first pathogen cultured of each episode) and All infection (the whole hospital susceptibility data)

Primary Objectives:

1. To study the impact of the introduction of ertapenem on the susceptibility pattern of various pathogens to imipenem/meropenem.

2. To study the impact of the introduction of ertapenem on the susceptibility of all Gram negative bacilli to antimicrobial agents commonly used in the participated study sites.

3. To explore the trend in antimicrobial utilization before and after the introduction of new antimicrobial agents to the hospital formulary during the index period.

Secondary Objectives:

1. To study the trend of antimicrobial susceptibility to ESBL-producing Enterobacteriaceae during the index period

2. To study the impact of the introduction of other newly introduced antibiotics (e.g., tigecycline) on the susceptibility pattern of various pathogens to carbapenems

3. To study the prevalence and trend of Pan drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa resistant during the index period

Exploratory objectives:

1) To explore the resistant rates of ESBL-producing Enterobacteriaceae, Pan drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa in different hospitals after adjusted DDD.

Hypotheses:

1. There will be no increase in the utilization rates of other antibiotics, specifically the other carbapenem drugs (imipenem, meropenem) in the index period (2-3 years before and 2-3 years after the introduction of ertapenem).

2. The introduction of ertapenem to the institution formulary will not negatively impact the susceptibility of selected bacterial isolates to the other carbapenem antibiotics. ;

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Diseases

• NCT number: NCT01611025
• Study type: Observational
• Source: Taipei Veterans General Hospital, Taiwan
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2011
• Completion date: December 2013