InfectionPRIORNCT07603128
Multicenter Validation of a Risk Prediction Model for MDRGNB Infection
An observational study of Infection, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 11 sites in China.
Trial summary
This prospective multicenter validation study aimed to evaluate the predictive performance of a previously developed model for MDRGNB infection in ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- How many people
- 1,000 participants
- Where
- 11 sitesChina
- Study dates
- 22 May 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult ICU patients
Who may be able to join
- Age ≥18 years;
- ICU stay ≥48 hours;
- At least one clinical microbiological specimen collected and submitted for testing within 48 hours of ICU admission, with the first submission time designated as the index time;
- Core predictive variables of the model extractable from electronic medical records or laboratory information systems.
Who cannot join
- For patients with multiple ICU admissions, only the first ICU stay was retained;
- Missing or indeterminate primary outcome;
- Missing key predictive variables that could not be handled according to prespecified rules.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Juan He, Professor, PharmD contact
11 sites in 1 country
China11 sites, 11 recruiting
- Not yet recruiting
Ankang People's Hospital
Ankang
Zhiying Gao, Pharmacist in Charge, +86-0915-3368788, 18704630749@163.com
Zhiying Gao
- Not yet recruiting
Sinopharm Tongmei General Hospital
Datong
Xiaomin Feng, Associate Professor, +86-0352-7028190, Fxm10010@163.com
Xiaomin Feng
- Not yet recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou
Peipei Liu, Pharmacist in Charge, PharmD, +86-0797-8266000, liupei0322@163.com
Peipei Liu
- Recruiting
Zhejiang Hospital
Hangzhou
Zhouye Song, Pharmacist in Charge, +86-0571-87987373, szy1066@126.com
Zhouye Song
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou
Xiaoyuan Chen, Associate Professor, PhD, +86-0571-87666666, chenxiaoyuan@hmc.edu.cn
Xiaoyuan Chen
- Not yet recruiting
Huaian First People's Hospital
Huaian
Yu Du, 0517-84907287, 1204624315@qq.com
Yu Du
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Dayu Chen, Pharmacist in Charge, PharmD, +86-025-83106666-60924, cdy_pharmacy@njglyy.com
Yao Du, MPharm
- Recruiting
Guangxi Provincial Tumor Hospital
Nanning
Linyu Wang, Pharmacist in Charge, +86-0771-5331955, 1044548733@qq.com
Linyu Wang
- Recruiting
Shanghai Ruijin Hospital
Shanghai
Juan He, Professor, PharmD, +86-021-64370045, hejuanwin@126.com
Juan He
- Not yet recruiting
Shaanxi Provincial People's Hospital
Xi'an
Lu Cao, Associate Professor, +86-029-85251331, caolu_cpu@163.com
Lu Cao
- Not yet recruiting
Zhanjiang Central People's Hospital
Zhanjiang
Xi Cao, Pharmacist in Charge, +86-0759-3157999, nkyy_cx@126.com
Xi Cao
About this study
Official title: Prospective Validation of a Risk Prediction Model for MDRGNB Infection: A Multicenter Real-World Prospective Study
This prospective multicenter validation study aimed to evaluate the predictive performance of a previously developed model for MDRGNB infection in ICU patients.
Read the detailed description
Adult ICU patients were prospectively and consecutively enrolled across 11 research centers. MDRGNB infection risk predictions were generated within 24 hours of ICU admission using routinely available clinical data. Without interfering with clinical decision-making, the study assessed the discrimination, calibration, and clinical net benefit of the previously developed MDRGNB infection risk prediction model in real-world practice, applying the predefined threshold of 0.318.
- Conditions
- Infection
- Keywords
- Prediction model, MDRGNB, ICU, Infection
- Medical subject headings
- Infections
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 |
|---|---|---|
| Observation group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDRGNB infection
The objective of this study was to observe whether enrolled patients developed early MDRGNB infection and to validate the model's performance. The occurrence of MDRGNB infection was adjudicated by integrating clinical manifestations with culture results from collected specimens.Baseline and model variables: Collected within 48 hours of ICU admission.Primary outcome: Determined based on the results of the first submitted specimen.
Measured: 48 hours after ICU admission
Secondary outcomes (3)
28-day mortality
28-day mortality
Measured: 28 day after ICU admission
Sequential Organ Failure Assessment (SOFA) score at 48 hours
SOFA score at 48 hours, higher SOFA score mean a worse outcome
Measured: 48 hours after ICU admission
Adverse events related to antibiotic within 28 days
Adverse events related to antibiotic within 28 days, defined by Naranjo scale.
Measured: 28 day after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start22 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Zhejiang Hospital
- Responsible party
- Principal investigator, Chen Dayu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603128
- Sponsor's protocol ID
- 2026-0453-02
- Acronym
- PRIOR
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified original data.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of a Risk Prediction Model for MDRGNB Infection: A Multicenter Real-World Prospective Study
- ClinicalTrials.gov ID
- NCT07603128
- Acronym / sponsor ID
- PRIOR / 2026-0453-02
- Conditions
- Infection
- Keywords
- Prediction model, MDRGNB, ICU, Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Zhejiang Hospital
- Study start
- 22 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 May 2026 (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.
This prospective multicenter validation study aimed to evaluate the predictive performance of a previously developed model for MDRGNB infection in ICU patients.
Detailed description
Adult ICU patients were prospectively and consecutively enrolled across 11 research centers. MDRGNB infection risk predictions were generated within 24 hours of ICU admission using routinely available clinical data. Without interfering with clinical decision-making, the study assessed the discrimination, calibration, and clinical net benefit of the previously developed MDRGNB infection risk prediction model in real-world practice, applying the predefined threshold of 0.318.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients
Key inclusion criteria (4 listed)
- Age ≥18 years;
- ICU stay ≥48 hours;
- At least one clinical microbiological specimen collected and submitted for testing within 48 hours of ICU admission, with the first submission time designated as the index time;
- Core predictive variables of the model extractable from electronic medical records or laboratory information systems.
Key exclusion criteria (3 listed)
- For patients with multiple ICU admissions, only the first ICU stay was retained;
- Missing or indeterminate primary outcome;
- Missing key predictive variables that could not be handled according to prespecified rules.
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
MDRGNB infection
Time frame: 48 hours after ICU admission
The objective of this study was to observe whether enrolled patients developed early MDRGNB infection and to validate the model's performance. The occurrence of MDRGNB infection was adjudicated by integrating clinical manifestations with culture results from collected specimens.Baseline and model variables: Collected within 48 hours of ICU admission.Primary outcome: Determined based on the results of the first submitted specimen.
3 secondary outcomes
28-day mortality
Time frame: 28 day after ICU admission
Sequential Organ Failure Assessment (SOFA) score at 48 hours
Time frame: 48 hours after ICU admission
Adverse events related to antibiotic within 28 days
Time frame: 28 day after admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Yes. De-identified original data.
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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.
Juan He, Professor, PharmD contact
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 11 sites 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 4 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: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dayu Chen, Pharmacist in Charge, PharmD (+86-025-83106666-60924, cdy_pharmacy@njglyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDRGNB infection (time frame: 48 hours after ICU admission). 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 27 May 2026.