Antibiotic Resistant InfectionNCT03980197
Strategy to Prevent Transmission of Multidrug-resistant Gram-negative Organisms in ICU
A study testing Active surveillance and preemptive isolation in people with Antibiotic Resistant Infection, run by Sung-Han Kim at 1 site in South Korea.
Trial summary
1. Objective of study The purpose of this study was to investigate whether the active surveillance and preemptive isolation of multidrug-resistant Gram-negative bacteria in the intensive care unit affected the reduction of the rate of acquisition of multidrug- resistant Gram-negative bacteria (MDRGNB). 2. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Antibiotic Resistant Infection
- What is being tested?
- Active surveillance and preemptive isolation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jun 2019to 30 Jun 2020
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Enroll all patients who admit to the ICUs during the study period
Who cannot join
- Patients who discharge within 2 days after admission to ICUs
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Jiwon Jung, MD, 82-10-3010-5041, trueblue27@naver.com
About this study
Official title: Strategy to Prevent Transmission of Multidrug-resistant Gram-negative Organisms in ICU - Evaluation of Effect of Active Surveillance Test
- Objective of study The purpose of this study was to investigate whether the active surveillance and preemptive isolation of multidrug-resistant Gram-negative bacteria in the intensive care unit affected the reduction of the rate of acquisition of multidrug- resistant Gram-negative bacteria (MDRGNB).
- Background Treatment option for MDRGNB (Carbapenem-resistant P. aeruginosa, Carbapenem-resistant A. baumannii, Carbapenem-resistant Enterobacteriaceae) is limited. Development of infection due to MDRGNB is common in ICU. Strategy to prevent transmission of MDRGNB is needed, and there is two approaches; First, antimicrobial stewardship program, and second, infection control strategy.The investigators aimed to figure out the role of active surveillance test and preemptive isolation of MDRGNB in reduction of acquisition rate of MDRGNB.
- Methods Pragmatic cluster randomized, crossover, controlled trial During first period (6 months), intervention group (randomized 3 ICUs) perform daily chlorhexidine bathing, active surveillance test and preemptive isolation and contact precaution. Control group (randomized 3 ICUs) perform standard precaution with daily chlorhexidine bathing, and start contact precaution when clinical isolates reveals MDRGNB.
After 1 month washout period, intervention group and control group cross over for next 6 months.
- Conditions
- Antibiotic Resistant Infection
- Being tested
- Active surveillance and preemptive isolation, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active surveillance and preemptive isolationOther
Active surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed.
ControlOther
No active surveillance and preemptive isolation. If clinical isolates are positive for MDRGNB, start contact precaution
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Active surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed. Receives: Other: Active surveillance and preemptive isolation |
| Control | Active comparator | No active surveillance test and preemptive isolation performed. Only standard precaution is needed, and if clinical isolates reveals MDRO, start contact precaution. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who acquired MDRGNB in ICU per 1000 patient-days
The number of patients who acquired MDRGNB in ICU per 1000 patient-days
Measured: through study completion, an average 6 months
Secondary outcomes (4)
Rate of bloodstream infection due to MDRGNB
Rate of bloodstream infection due to MDRGNB
Measured: through study completion, an average 6 months
Hand hygiene compliance rates (%) of healthcare workers
number of Hand hygiene compliance/number of opportunicities for hand hygiene of healthcare workers *100
Measured: through study completion, an average 1 year
Days of ICU stay
Days of ICU stay
Measured: through study completion, an average 6 months
28-day mortality rate
28-day mortality rate
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start3 Jun 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
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 Antibiotic Resistant 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sung-Han Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sung-Han Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980197
- Sponsor's protocol ID
- 2019-0274
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jung J, Park JH, Yang H, Lim YJ, Kim EO, Lim CM, Kim MN, Jo MW, Yun SC, Kim SH. Active surveillance testing to reduce transmission of carbapenem-resistant, gram-negative bacteria in intensive care units: a pragmatic, randomized cross-over trial. Antimicrob Resist Infect Control. 2023 Mar 3;12(1):16. doi: 10.1186/s13756-023-01222-2.
PubMed 36869371
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy to Prevent Transmission of Multidrug-resistant Gram-negative Organisms in ICU - Evaluation of Effect of Active Surveillance Test
- ClinicalTrials.gov ID
- NCT03980197
- Acronym / sponsor ID
- 2019-0274
- Conditions
- Antibiotic Resistant Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Sung-Han KimUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 10 Jun 2019 (actual)
- 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.
- Objective of study The purpose of this study was to investigate whether the active surveillance and preemptive isolation of multidrug-resistant Gram-negative bacteria in the intensive care unit affected the reduction of the rate of acquisition of multidrug- resistant Gram-negative bacteria (MDRGNB).
- Background Treatment option for MDRGNB (Carbapenem-resistant P. aeruginosa, Carbapenem-resistant A. baumannii, Carbapenem-resistant Enterobacteriaceae) is limited. Development of infection due to MDRGNB is common in ICU. Strategy to prevent transmission of MDRGNB is needed, and there is two approaches; First, antimicrobial stewardship program, and second, infection control strategy.The investigators aimed to figure out the role of active surveillance test and preemptive isolation of MDRGNB in reduction of acquisition rate of MDRGNB.
- Methods Pragmatic cluster randomized, crossover, controlled trial During first period (6 months), intervention group (randomized 3 ICUs) perform daily chlorhexidine bathing, active surveillance test and preemptive isolation and contact precaution. Control group (randomized 3 ICUs) perform standard precaution with daily chlorhexidine bathing, and start contact precaution when clinical isolates reveals MDRGNB.
After 1 month washout period, intervention group and control group cross over for next 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Active surveillance and preemptive isolationActive surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed. |
| Control | Active comparator | Other: ControlNo active surveillance test and preemptive isolation performed. Only standard precaution is needed, and if clinical isolates reveals MDRO, start contact precaution. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Enroll all patients who admit to the ICUs during the study period
Key exclusion criteria (1 listed)
- Patients who discharge within 2 days after admission to ICUs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active surveillance and preemptive isolationActive surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed. | Other | Intervention |
| ControlNo active surveillance and preemptive isolation. If clinical isolates are positive for MDRGNB, start contact precaution | Other | Control |
Primary outcome
The number of patients who acquired MDRGNB in ICU per 1000 patient-days
Time frame: through study completion, an average 6 months
The number of patients who acquired MDRGNB in ICU per 1000 patient-days
4 secondary outcomes
Rate of bloodstream infection due to MDRGNB
Time frame: through study completion, an average 6 months
Hand hygiene compliance rates (%) of healthcare workers
Time frame: through study completion, an average 1 year
Days of ICU stay
Time frame: through study completion, an average 6 months
28-day mortality rate
Time frame: 28-days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Derived from this study: PubMed 36869371Jung J, Park JH, Yang H, Lim YJ, Kim EO, Lim CM, Kim MN, Jo MW, Yun SC, Kim SH. Active surveillance testing to reduce transmission of carbapenem-resistant, gram-negative bacteria in intensive care units: a pragmatic, randomized cross-over trial. Antimicrob Resist Infect Control. 2023 Mar 3;12(1):16. doi: 10.1186/s13756-023-01222-2.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active surveillance and preemptive isolation in people with Antibiotic Resistant Infection, run by Sung-Han Kim at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiwon Jung, MD (82-10-3010-5041, trueblue27@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who acquired MDRGNB in ICU per 1000 patient-days (time frame: through study completion, an average 6 months). 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 NCT03980197, 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 10 Jun 2019.