Carbapenem-Resistant Enterobacteriaceae InfectionNCT04535661
Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children
An observational study of Carbapenem-Resistant Enterobacteriaceae Infection, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Carbapenem-resistant Enterobacteriaceae (CRE) are increasingly identified in children in China. Pediatric intensive care unit (PICU) is the high-risk area. However, data on the epidemiology of CRE in hospitalized children in PICU are limited. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Carbapenem-Resistant Enterobacteriaceae Infection
- How many people
- 536 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 2026
- 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 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019
Who may be able to join
- All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019.
Who cannot join
- discharge within 48 hours
- patients had a positive culture for CRE before admission
- incomplete clinical and demographic data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
Guoping Lu, MD, 18017590817, 13788904150@163.com
About this study
Official title: A Retrospective Single Center Study of the Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in PICU Hospitalized Children
Carbapenem-resistant Enterobacteriaceae (CRE) are increasingly identified in children in China. Pediatric intensive care unit (PICU) is the high-risk area. However, data on the epidemiology of CRE in hospitalized children in PICU are limited. The objectives of this study are to characterize the risk factors for colonization or infection with CRE and describe the microbiologic characteristics of pediatric CRE isolates. The investigators will perform a single retrospective study from January 2018 to December 2019 at PICU of Children's Hospital of Fudan University .
Read the detailed description
The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit PICU of Children's Hospital of Fudan University from January 2018 to December 2019. Children who had positive cultures for any Enterobacteriaceae species before their admission will be excluded. Children with a PICU length of day less than 48h will also be excluded. According to their clinical cultures results, they will be divided into non-CRE、CRE colonization and CRE infection. CRE was defined according to the 2015 Centers for Disease Control and Prevention (CDC) definition as an isolate resistant to imipenem, meropenem, or ertapenem. Clinical and demographic data will be collected from the electronic health record.
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 |
|---|---|---|
| non CRE | Children with a negative culture for CRE during their stay in PICU are defined as non CRE. | |
| CRE colonization | Children who have a positive culture for CRE during their stay in PICU but lack of clinical symptoms are defined as CRE colonization. | |
| CRE infection | Children who have a positive culture for CRE during their stay in PICU combined with clinical symptoms are defined as CRE infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
The death rate of children in 28 days after their discharged from PICU
Measured: within 28 days after they discharged from PICU
Secondary outcomes (1)
length of stay in PICU
Time from PICU admission to discharge
Measured: within 28 days after they discharged from PICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Mar 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem-Resistant Enterobacteriaceae InfectionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Retrospective
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gangfeng Yan, Principal investigator, Children's Hospital of Fundan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535661
- Sponsor's protocol ID
- fdpicu-05
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2020
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Single Center Study of the Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in PICU Hospitalized Children
- ClinicalTrials.gov ID
- NCT04535661
- Acronym / sponsor ID
- fdpicu-05
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Sep 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.
Carbapenem-resistant Enterobacteriaceae (CRE) are increasingly identified in children in China. Pediatric intensive care unit (PICU) is the high-risk area. However, data on the epidemiology of CRE in hospitalized children in PICU are limited. The objectives of this study are to characterize the risk factors for colonization or infection with CRE and describe the microbiologic characteristics of pediatric CRE isolates. The investigators will perform a single retrospective study from January 2018 to December 2019 at PICU of Children's Hospital of Fudan University .
Detailed description
The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit PICU of Children's Hospital of Fudan University from January 2018 to December 2019. Children who had positive cultures for any Enterobacteriaceae species before their admission will be excluded. Children with a PICU length of day less than 48h will also be excluded. According to their clinical cultures results, they will be divided into non-CRE、CRE colonization and CRE infection. CRE was defined according to the 2015 Centers for Disease Control and Prevention (CDC) definition as an isolate resistant to imipenem, meropenem, or ertapenem. Clinical and demographic data will be collected from the electronic health record.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non CRE | – | –Children with a negative culture for CRE during their stay in PICU are defined as non CRE. |
| CRE colonization | – | –Children who have a positive culture for CRE during their stay in PICU but lack of clinical symptoms are defined as CRE colonization. |
| CRE infection | – | –Children who have a positive culture for CRE during their stay in PICU combined with clinical symptoms are defined as CRE infection. |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019
Key inclusion criteria (1 listed)
- All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019.
Key exclusion criteria (3 listed)
- discharge within 48 hours
- patients had a positive culture for CRE before admission
- incomplete clinical and demographic data
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
mortality
Time frame: within 28 days after they discharged from PICU
The death rate of children in 28 days after their discharged from PICU
1 secondary outcome
length of stay in PICU
Time frame: within 28 days after they discharged from PICU
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 16 Mar 2026.
- 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.
Gangfeng Yan principal investigator
Children's Hospital of Fundan University
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 Carbapenem-Resistant Enterobacteriaceae Infection, run by Children's Hospital of Fudan University 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 1 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 16 Mar 2026. 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?
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 Gangfeng Yan (+8615900603082, jinyi036@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: within 28 days after they discharged from PICU). 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 16 Mar 2026.