Infectious DiseasesNCT01611025
Hospital Microbial Ecology Follow the Introduction of Ertapenem and Other Newly Introduced Antibiotic Over Time
An observational study of Infectious Diseases, run by Taipei Veterans General Hospital, Taiwan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Diseases
- How many people
- 30,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: selected bacterial isolates, such as but not limited to Pseudomonas aeruginosa, Acinetobacter Baumannii and Enterobacteriaceae species
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
About this study
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
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.
Read the detailed 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:
- 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:
- 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.
- Conditions
- Infectious Diseases
- Medical subject headings
- Communicable Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJun 2011
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseasesStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fu-Der Wang, M.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611025
- Sponsor's protocol ID
- MISP39134
- Status last verified
- May 2012
- First submitted
- 1 Oct 2011
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01611025
- Acronym / sponsor ID
- MISP39134
- Conditions
- Infectious Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Jun 2011
- Study completion
- Dec 2013 (estimated)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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:
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- selected bacterial isolates, such as but not limited to Pseudomonas aeruginosa, Acinetobacter Baumannii and Enterobacteriaceae species
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fu-Der Wang, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Diseases, run by Taipei Veterans General Hospital, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2012.