InfectionNCT01667991
Evaluation of the American Thoracic Society Criteria for Predicting Multidrug-resistant Bacteria in Critically Ill Patients
An observational study of Infection, run by Southeast University, China.
Trial summary
Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are different between countries, will affect the accuracy of etiological diagnoses according to the American Thoracic Society (ATS)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Infection
- How many people
- 610 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Sep 2011
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients admitted to icu
Who may be able to join
- All patients hospitalized in the ICU were eligible for this study
Who cannot join
None listed.
About this study
Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are different between countries, will affect the accuracy of etiological diagnoses according to the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria in China.
Read the detailed description
All data concerning patient characteristics at ICU admission and during ICU stay were prospectively collected.Screening for MDR bacteria (using nasal swabs, tracheal aspirates from intubated patients and specimens from the infection location) was performed at ICU admission and discharge. Risk factors for infection or colonization with MDR bacteria were recorded, and the accuracy of the ATS criteria in predicting infection or colonization with these bacteria at ICU admission was documented. All of the infected patients were treated by the attending physician, and the choice and adjustment of antibiotic were in accordance with the recommendations of the ATS guidelines.
- Conditions
- Infection
- Keywords
- Colonization, infection, multidrug-resistant bacteria, guideline
- Medical subject headings
- Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startApr 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Jianfeng Xie, MD, Study director, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667991
- Sponsor's protocol ID
- MDR in China 123
- Status last verified
- Aug 2012
- First submitted
- 12 Aug 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xie J, Ma X, Huang Y, Mo M, Guo F, Yang Y, Qiu H. Value of American Thoracic Society guidelines in predicting infection or colonization with multidrug-resistant organisms in critically ill patients. PLoS One. 2014 Mar 19;9(3):e89687. doi: 10.1371/journal.pone.0089687. eCollection 2014.
PubMed 24647408
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the American Thoracic Society Criteria for Predicting Multidrug-resistant Bacteria in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01667991
- Acronym / sponsor ID
- MDR in China 123
- Conditions
- Infection
- Keywords
- Colonization, infection, multidrug-resistant bacteria, guideline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Apr 2010
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Aug 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.
Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are different between countries, will affect the accuracy of etiological diagnoses according to the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria in China.
Detailed description
All data concerning patient characteristics at ICU admission and during ICU stay were prospectively collected.Screening for MDR bacteria (using nasal swabs, tracheal aspirates from intubated patients and specimens from the infection location) was performed at ICU admission and discharge. Risk factors for infection or colonization with MDR bacteria were recorded, and the accuracy of the ATS criteria in predicting infection or colonization with these bacteria at ICU admission was documented. All of the infected patients were treated by the attending physician, and the choice and adjustment of antibiotic were in accordance with the recommendations of the ATS guidelines.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to icu
Key inclusion criteria (1 listed)
- All patients hospitalized in the ICU were eligible for this study
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
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 20 Aug 2012.
- Derived from this study: PubMed 24647408Xie J, Ma X, Huang Y, Mo M, Guo F, Yang Y, Qiu H. Value of American Thoracic Society guidelines in predicting infection or colonization with multidrug-resistant organisms in critically ill patients. PLoS One. 2014 Mar 19;9(3):e89687. doi: 10.1371/journal.pone.0089687. eCollection 2014.
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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.
Jianfeng Xie, MD study director
Zhongda Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Southeast University, China.
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 1 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: finished, as of the sponsor's last update on 20 Aug 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01667991, which also lists 1 linked publication.
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 20 Aug 2012.