Nosocomial InfectionNCT00864929
An Epidemiological Study on Antimicrobial Treatment of Nosocomial Infections in Clinical Practice
An observational study of Nosocomial Infection, run by AstraZeneca at 2 sites in Vietnam.
Trial summary
The present study is a retrospective cohort study on patients who suffered a nosocomial infection in major hospitals in Vietnam. Data relating to patient demography include age, gender; medical history; APACHE II score; background conditions, infection details and antimicrobial therapy; and all-caused mortality, time… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nosocomial Infection
- How many people
- 1,500 participants
- Where
- 2 sitesVietnam
- Study dates
- Nov 2009to Oct 2010
- 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: Patient was diagnosed as nosocomial infection
Who may be able to join
- Patient was diagnosed as nosocomial infection defined according to criteria established by the US CDC. The diagnosis criteria for ventilator-associated pneumonia are modified from those established by the American College of Chest Physicians.
- Patient received empiric antimicrobial therapy within 24 hour from onset of infection and had antimicrobial susceptibility.
Who cannot join
- A patient was in part of a controlled clinical trial for the current infection episode.
- Patients with suspected infections by virus or fungus or tuberculosis will be excluded.
Trial locations and contacts
2 sites in 1 country.
About this study
The present study is a retrospective cohort study on patients who suffered a nosocomial infection in major hospitals in Vietnam. Data relating to patient demography include age, gender; medical history; APACHE II score; background conditions, infection details and antimicrobial therapy; and all-caused mortality, time of hospitalization and intensive care. The investigators hypothesis is that antimicrobial treatment inappropriate is highly dependent on incidence of antibiotic resistant pathogens, nonfermentative Gram-negative bacilli and ESBL-producing enterobacteriaceae spp. Variables are demographic characteristics, background conditions, immunosuppressive therapy, antimicrobial susceptibility and inappropriate treatment is explored as possible predictors of mortality.
- Conditions
- Nosocomial Infection
- Keywords
- Non-interventional study, Vietnam, inappropriate treatment, nosocomial infection
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Appropriate antimicrobial treatment | |
| 2 | Inappropriate antimicrobial treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and percentage of subjects with nosocomial infection received appropriate antimicrobial treatment
Measured: 30 days as from onset of nosocomial infection
Secondary outcomes (3)
The number and percentage of patients with nosocomial infections received de-escalation therapy
Measured: 30 days as from onset of nosocomial infection
The number and percentage of hospital mortality, the number of days for hospitalization, intensive care among groups of patients who received appropriate or inappropriate antimicrobial treatments
Measured: 30 days as from onset of nosocomial infection
The determinants for inappropriate antimicrobial treatment and mortality.
Measured: 30 days as from onset of nosocomial infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Phan Anh Tuan Nguyen, MD, Study director, AstraZeneca VietnamTo Nhu Le, MD, Principal investigator, National Paediatric InsituteViet Hoa Le, Principal investigator, The 108 Military Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864929
- Sponsor's protocol ID
- NIS-IVN-DUM-2008/1
- Status last verified
- Feb 2011
- First submitted
- 18 Mar 2009
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Study on Antimicrobial Treatment of Nosocomial Infections in Clinical Practice
- ClinicalTrials.gov ID
- NCT00864929
- Acronym / sponsor ID
- NIS-IVN-DUM-2008/1
- Conditions
- Nosocomial Infection
- Keywords
- Non-interventional study, Vietnam, inappropriate treatment, nosocomial infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Mar 2009 (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.
The present study is a retrospective cohort study on patients who suffered a nosocomial infection in major hospitals in Vietnam. Data relating to patient demography include age, gender; medical history; APACHE II score; background conditions, infection details and antimicrobial therapy; and all-caused mortality, time of hospitalization and intensive care. The investigators hypothesis is that antimicrobial treatment inappropriate is highly dependent on incidence of antibiotic resistant pathogens, nonfermentative Gram-negative bacilli and ESBL-producing enterobacteriaceae spp. Variables are demographic characteristics, background conditions, immunosuppressive therapy, antimicrobial susceptibility and inappropriate treatment is explored as possible predictors of mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Appropriate antimicrobial treatment |
| 2 | – | –Inappropriate antimicrobial treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient was diagnosed as nosocomial infection
Key inclusion criteria (2 listed)
- Patient was diagnosed as nosocomial infection defined according to criteria established by the US CDC. The diagnosis criteria for ventilator-associated pneumonia are modified from those established by the American College of Chest Physicians.
- Patient received empiric antimicrobial therapy within 24 hour from onset of infection and had antimicrobial susceptibility.
Key exclusion criteria (2 listed)
- A patient was in part of a controlled clinical trial for the current infection episode.
- Patients with suspected infections by virus or fungus or tuberculosis will be excluded.
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
The number and percentage of subjects with nosocomial infection received appropriate antimicrobial treatment
Time frame: 30 days as from onset of nosocomial infection
3 secondary outcomes
The number and percentage of patients with nosocomial infections received de-escalation therapy
Time frame: 30 days as from onset of nosocomial infection
The number and percentage of hospital mortality, the number of days for hospitalization, intensive care among groups of patients who received appropriate or inappropriate antimicrobial treatments
Time frame: 30 days as from onset of nosocomial infection
The determinants for inappropriate antimicrobial treatment and mortality.
Time frame: 30 days as from onset of nosocomial infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
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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.
Phan Anh Tuan Nguyen, MD study director
AstraZeneca Vietnam
To Nhu Le, MD principal investigator
National Paediatric Insitute
Viet Hoa Le principal investigator
The 108 Military Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nosocomial Infection, run by AstraZeneca at 2 sites in Vietnam.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
The number and percentage of subjects with nosocomial infection received appropriate antimicrobial treatment (time frame: 30 days as from onset of nosocomial infection). It is what the study was designed to measure, not a finding.
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 16 Feb 2011.