Bacterial InfectionsNCT04688216
Developing a Risk Assessment System of Multidrug-resistant Organisms Infection
An observational study of Bacterial Infections, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
1. A retrospective analysis was performed to determine the prevalence of multidrug- resistant organisms infection in ICU from October 2017 to October 2019. 2. Non-MDRO patients were selected by random sampling in a ratio of 1:1 to the final MDRO group during the same period , and select the risk factors of infection… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- risk factors of infection with multidrug-resistant organisms
- How many people
- 917 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ①Length of stay in ICU is more than 48h; ② no less than 18 years old.
Who may be able to join
- Duration of ICU admission ≥ 48h
- no less than 18 years old
Who cannot join
- Patients with MDRO infection at the time of admission
- Lack of case data
- MDRO colonized patients
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Developing the Best Risk Assessment System of Multidrug-resistant Organisms Infection in Critically Ill Patients Based on Big Data Analysis Technology
- A retrospective analysis was performed to determine the prevalence of multidrug- resistant organisms infection in ICU from October 2017 to October 2019.
- Non-MDRO patients were selected by random sampling in a ratio of 1:1 to the final MDRO group during the same period , and select the risk factors of infection with multi-drug resistant bacteria by comparing the two groups.
- Randomly select 30% of the sample size as the validation set, and the remaining 70% for the training set to establish a model. Using multi-factor Logistic regression, decision tree classification, artificial neural network, support vector machine, Bayesian network Method to establish risk assessment system for multidrug-resistant organisms infection respectively.Using validation set data to calculate the area under the ROC curve (AUC) and sensitivity, specificity of models and comparing the prediction accuracy of several models. Finally, choose a more suitable risk assessment system for multidrug-resistant organisms infection.
- Predict the patient's infection risk level according to the best risk assessment system and develop a low-to-high intervention plan.
- Conditions
- Bacterial Infections
- Being tested
- risk factors of infection with multidrug-resistant organisms
- Keywords
- risk assessment system, multidrug-resistant organisms, ICU
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risk factors of infection with multidrug-resistant organismsOther
- General information: age, gender, length of stay in ICU, method of admission, tubes taken at the time of admission, APACHEⅡ score, surgery, laboratory tests (PCT, CRP, WBC), pressure sores, etc.
- Iatrogenic factors: days of using ventilator, days of using antibacterial drugs, types of antibacterial drugs, use of glucocorticoids, use of immunosuppressants, days of central venous intubation, days of indwelling catheters, days of arterial catheterization, and other indwelling catheters.
- The patient's own related factors: diagnosis, whether complicated with hypertension or diabetes; whether exist malignant tumor, primary lung infection, hypoproteinemia; whether antibiotic treatment before admission; fever and fever days, whether diarrhea occurs
| Study group | Role | What they receive |
|---|---|---|
| MDRO | Not described Receives: Other: risk factors of infection with multidrug-resistant organisms | |
| Non-MDRO | Not described Receives: Other: risk factors of infection with multidrug-resistant organisms |
What is being measured
The primary outcome is the main question the study is designed to answer.
multidrug-resistant organisms infection
Ratio of the number of multi-drug resistant bacterial infections to the total number of patients
Measured: From date of ICU admissions until the date of ICU discharge or date of diagnosis of multidrug-resistant organisms infection , whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jan 2020
- Primary completion1 May 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 917 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688216
- Sponsor's protocol ID
- 2020-408
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2020
- Last updated
- 26 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing the Best Risk Assessment System of Multidrug-resistant Organisms Infection in Critically Ill Patients Based on Big Data Analysis Technology
- ClinicalTrials.gov ID
- NCT04688216
- Acronym / sponsor ID
- 2020-408
- Conditions
- Bacterial Infections
- Keywords
- risk assessment system, multidrug-resistant organisms, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 917 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 29 Dec 2020 (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.
- A retrospective analysis was performed to determine the prevalence of multidrug- resistant organisms infection in ICU from October 2017 to October 2019.
- Non-MDRO patients were selected by random sampling in a ratio of 1:1 to the final MDRO group during the same period , and select the risk factors of infection with multi-drug resistant bacteria by comparing the two groups.
- Randomly select 30% of the sample size as the validation set, and the remaining 70% for the training set to establish a model. Using multi-factor Logistic regression, decision tree classification, artificial neural network, support vector machine, Bayesian network Method to establish risk assessment system for multidrug-resistant organisms infection respectively.Using validation set data to calculate the area under the ROC curve (AUC) and sensitivity, specificity of models and comparing the prediction accuracy of several models. Finally, choose a more suitable risk assessment system for multidrug-resistant organisms infection.
- Predict the patient's infection risk level according to the best risk assessment system and develop a low-to-high intervention plan.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDRO | – | Other: risk factors of infection with multidrug-resistant organisms |
| Non-MDRO | – | Other: risk factors of infection with multidrug-resistant organisms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ①Length of stay in ICU is more than 48h; ② no less than 18 years old.
Key inclusion criteria (2 listed)
- Duration of ICU admission ≥ 48h
- no less than 18 years old
Key exclusion criteria (3 listed)
- Patients with MDRO infection at the time of admission
- Lack of case data
- MDRO colonized patients
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 |
|---|---|---|
| risk factors of infection with multidrug-resistant organisms1. General information: age, gender, length of stay in ICU, method of admission, tubes taken at the time of admission, APACHEⅡ score, surgery, laboratory tests (PCT, CRP, WBC), pressure sores, etc. 2. Iatrogenic factors: days of using ventilator, days of using antibacterial drugs, types of antibacterial drugs, use of glucocorticoids, use of immunosuppressants, days of central venous intubation, days of indwelling catheters, days of arterial catheterization, and other indwelling catheters. 3. The patient's own related factors: diagnosis, whether complicated with hypertension or diabetes; whether exist malignant tumor, primary lung infection, hypoproteinemia; whether antibiotic treatment before admission; fever and fever days, whether diarrhea occurs | Other | MDRO, Non-MDRO |
Primary outcome
multidrug-resistant organisms infection
Time frame: From date of ICU admissions until the date of ICU discharge or date of diagnosis of multidrug-resistant organisms infection , whichever came first, assessed up to 24 months
Ratio of the number of multi-drug resistant bacterial infections to the total number of patients
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 26 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in 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 2 inclusion and 3 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 26 May 2023. 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 China. 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?
multidrug-resistant organisms infection (time frame: From date of ICU admissions until the date of ICU discharge or date of diagnosis of multidrug-resistant organisms infection , whichever came first, assessed up to 24 months). 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 26 May 2023.