SepsisNCT02128399
Antimicrobial Stewardship Reduces MDRO Isolates in Critically Ill Patients
An observational study of Sepsis, run by Jianfeng Xie.
Trial summary
Antimicrobial exposure is known to reduce the selection for various drug-resistant organisms. Numerous studies have demonstrated the association between antimicrobial use and MDR bacteria detection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis
- How many people
- 978 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to 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: patients who admitted into intensive care unit
Who may be able to join
- Patients hospitalized in the ICU
Who cannot join
- Patients who were readmitted to the ICU during a single hospital stay
About this study
Antimicrobial exposure is known to reduce the selection for various drug-resistant organisms. Numerous studies have demonstrated the association between antimicrobial use and MDR bacteria detection. However, to the investigators knowledge, there is few data to support the concept that reducing antibiotic use actually leads to improvements in antibiotic susceptibilities. Moreover, antimicrobial stewardship was demonstrated to reduce MDRO and was strongly recommended in clinics. As the investigators know, antimicrobial overuse, which occurs commonly in China, induces a severe antibacterial resistance. China's Ministry of Health (MOH) has established a policy about the antimicrobial stewardship. To date, the investigators do not have published documentation the effects of this policy on multidrug-resistant organism (MDRO) in critically ill patients.
- Conditions
- Sepsis
- Keywords
- antimicrobial stewardship
- Medical subject headings
- Sepsis
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 |
|---|---|---|
| patients before and after intervetion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participates infection or colonization with MDRO in critically ill patients at ICU admission and discharge as a measure of effect of antimicrobial stewardship
MDRO isolation from inclusion to the date of discharge of hospital, access up to 90 days
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionDec 2013
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 SepsisStudies 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
- Time perspective
- Prospective
- Enrolment
- 978 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128399
- Sponsor's protocol ID
- MDRO
- Status last verified
- Jul 2012
- First submitted
- 22 Apr 2014
- Last updated
- 1 May 2014
- Results posted
- No
Publications
Ma X, Xie J, Yang Y, Guo F, Gao Z, Shao H, Huang Y, Yang C, Qiu H. Antimicrobial stewardship of Chinese ministry of health reduces multidrug-resistant organism isolates in critically ill patients: a pre-post study from a single center. BMC Infect Dis. 2016 Nov 25;16(1):704. doi: 10.1186/s12879-016-2051-8.
PubMed 27887595
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Stewardship Reduces MDRO Isolates in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02128399
- Acronym / sponsor ID
- MDRO
- Conditions
- Sepsis
- Keywords
- antimicrobial stewardship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 978 participants (actual)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 May 2014 (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.
Antimicrobial exposure is known to reduce the selection for various drug-resistant organisms. Numerous studies have demonstrated the association between antimicrobial use and MDR bacteria detection. However, to the investigators knowledge, there is few data to support the concept that reducing antibiotic use actually leads to improvements in antibiotic susceptibilities. Moreover, antimicrobial stewardship was demonstrated to reduce MDRO and was strongly recommended in clinics. As the investigators know, antimicrobial overuse, which occurs commonly in China, induces a severe antibacterial resistance. China's Ministry of Health (MOH) has established a policy about the antimicrobial stewardship. To date, the investigators do not have published documentation the effects of this policy on multidrug-resistant organism (MDRO) in critically ill patients.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients before and after intervetion | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who admitted into intensive care unit
Key inclusion criteria (1 listed)
- Patients hospitalized in the ICU
Key exclusion criteria (1 listed)
- Patients who were readmitted to the ICU during a single hospital stay
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 of participates infection or colonization with MDRO in critically ill patients at ICU admission and discharge as a measure of effect of antimicrobial stewardship
Time frame: up to 90 days
MDRO isolation from inclusion to the date of discharge of hospital, access up to 90 days
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 1 May 2014.
- Derived from this study: PubMed 27887595Ma X, Xie J, Yang Y, Guo F, Gao Z, Shao H, Huang Y, Yang C, Qiu H. Antimicrobial stewardship of Chinese ministry of health reduces multidrug-resistant organism isolates in critically ill patients: a pre-post study from a single center. BMC Infect Dis. 2016 Nov 25;16(1):704. doi: 10.1186/s12879-016-2051-8.
Related trials for Sepsis
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
RecruitingPhase 3
THE ROLE OF PANCREATIC STONE PROTEIN (PSP) AND PSP-GUIDED EARLY MEROPENEM TREATMENT TO MITIGATE SEPSIS RISK AT THE EMERGENCY DEPARTMENT: THE PROMISE DOUBLE BLIND, PHASE III, RANDOMIZED CONTROLLED CLINICAL TRIAL
Sepsis
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Jianfeng Xie.
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 1 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 1 May 2014. 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.
What does the primary outcome measure?
The number of participates infection or colonization with MDRO in critically ill patients at ICU admission and discharge as a measure of effect of antimicrobial stewardship (time frame: up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128399, 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 1 May 2014.