Assessing cefuroxime use in newborns
Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates
Shandong University · NCT05388747
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | Shandong University (other) |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05388747 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates aged 28 days or younger who are being treated with cefuroxime.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tianjin, Tianjin
- Tianjin Central Hospital of Gynecology Obstetrics — Tianjin, Tianjin, China (RECRUITING)
Study contacts
- Study coordinator: Wei Zhao, Ph.D
- Email: zhao4wei2@hotmail.com
- Phone: 86053188383308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infectious Disease