- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01611025
Hospital Microbial Ecology Follow the Introduction of Ertapenem and Other Newly Introduced Antibiotic Over Time
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
연구 개요
상태
정황
상세 설명
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:
- To study the impact of the introduction of ertapenem on the susceptibility pattern of various pathogens to imipenem/meropenem.
- 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.
- 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:
- To study the trend of antimicrobial susceptibility to ESBL-producing Enterobacteriaceae during the index period
- To study the impact of the introduction of other newly introduced antibiotics (e.g., tigecycline) on the susceptibility pattern of various pathogens to carbapenems
- 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:
- 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).
- The introduction of ertapenem to the institution formulary will not negatively impact the susceptibility of selected bacterial isolates to the other carbapenem antibiotics.
연구 유형
등록 (예상)
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- the susceptibility of Pseudomonas aeruginosa
- the susceptibility of Escherichia coli (ESBL and Non-ESBL producing strains)
- the susceptibility of Klebsiella pneumoniae(ESBL and Non-ESBL producing strains)
- the susceptibility of Enterobacter cloacae
- the susceptibility of Enterobacter aerogenes
- the susceptibility of Acinetobacter baumannii
- antibiotic utilization data of carbapenems: Ertapenem, Meropenem, Imipenem
- antibiotic utilization data of Penicillins: Piperacillin/Tazobactam
- antibiotic utilization data of cephalosporins: Ceftriaxone, Cefotaxime, Flomoxef, Cefoperazone, Ceftazidime, cefepime, Cefpirome
- antibiotic utilization data of Aztreonam,
- antibiotic utilization data of fluoroquinolones: Ciprofloxacin, Levofloxacin
- antibiotic utilization data of aminomethylcyclines: Tigecycline
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
공동 작업자 및 조사자
수사관
- 수석 연구원: Fu-Der Wang, M.D., Taipei Veterans General Hospital, Taiwan
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .