Assessing cefuroxime use in newborns
Official title: Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates
Run by Shandong University · NCT05388747 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing how well the antibiotic cefuroxime works and is tolerated in newborns under 28 days old who are being treated for bacterial infections.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 28 Days |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05388747 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are neonates aged 28 days or younger who are being treated with cefuroxime.
✕Probably not a fit
Patients who are not expected to survive the treatment cycle or are receiving other systemic trial drug therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the population pharmacokinetics, effectiveness, and safety of cefuroxime, an antibiotic used to treat bacterial infections, specifically in neonates. By analyzing data from infants aged 28 days or younger who are receiving cefuroxime as part of their antimicrobial treatment, the study seeks to fill the existing knowledge gap regarding its use in this vulnerable population. Parental consent is required for participation, and the study will exclude infants with a very limited expected survival time or those receiving other systemic trial drugs.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safe and effective use of cefuroxime in treating infections in neonates.
How similar studies have gone: While there is limited data on cefuroxime specifically in neonates, similar studies assessing antibiotics in this population have shown the importance of tailored pharmacokinetic data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: postnatal age ≤28 days; * Cefuroxime used as part of antimicrobial treatment; * Parental written consent. Exclusion Criteria: * Expected survival time less than the treatment cycle; * Receiving other systemic trial drug therapy; * Other factors that the researcher considers unsuitable for inclusion.
Where it's running
-
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, Tianjin, China Recruiting
Study contacts
- Study coordinator: Wei Zhao, Ph.D
- Email: zhao4wei2@hotmail.com
- Phone: 86053188383308
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.