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Recruiting NCT04535661

NCT04535661 Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children

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Clinical Trial Summary
NCT ID NCT04535661
Status Recruiting
Phase
Sponsor Children's Hospital of Fudan University
Condition Carbapenem-Resistant Enterobacteriaceae Infection
Study Type OBSERVATIONAL
Enrollment 536 participants
Start Date 2021-03-01
Primary Completion 2026-12-31

Eligibility & Interventions

Sex All sexes
Min Age 29 Days
Max Age 18 Years
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 536 participants in total. It began in 2021-03-01 with a primary completion date of 2026-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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. 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 .

Eligibility Criteria

Inclusion Criteria: * All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019. Exclusion Criteria: * discharge within 48 hours * patients had a positive culture for CRE before admission * incomplete clinical and demographic data

Contact & Investigator

Central Contact

Gangfeng Yan

✉ jinyi036@126.com

📞 +8615900603082

Principal Investigator

Gangfeng Yan

PRINCIPAL INVESTIGATOR

Children's Hospital of Fundan University

Frequently Asked Questions

Who can join the NCT04535661 clinical trial?

This trial is open to participants of all sexes, aged 29 Days or older, up to 18 Years, studying Carbapenem-Resistant Enterobacteriaceae Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04535661 currently recruiting?

Yes, NCT04535661 is actively recruiting participants. Contact the research team at jinyi036@126.com for enrollment information.

Where is the NCT04535661 trial being conducted?

This trial is being conducted at Shanghai, China.

Who is sponsoring the NCT04535661 clinical trial?

NCT04535661 is sponsored by Children's Hospital of Fudan University. The principal investigator is Gangfeng Yan at Children's Hospital of Fundan University. The trial plans to enroll 536 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology