Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates
Launched by SHANDONG UNIVERSITY · May 22, 2022
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of cefuroxime, an antibiotic, in newborns who are 28 days old or younger. Cefuroxime is used to treat bacterial infections, but we don't have enough information about how it works in very young patients. The goal of this study is to understand how the drug is processed in the body, how effective it is at treating infections, and whether it is safe for these infants.
To participate, babies need to be 28 days old or younger and must be receiving cefuroxime as part of their treatment. Parents will need to give written consent for their baby to join the study. Unfortunately, babies who are not expected to survive the treatment period or who are receiving other trial medications will not be eligible. If a baby does join the trial, parents can expect close monitoring to ensure the safety and effectiveness of cefuroxime during the treatment. Overall, this study aims to gather important information that could help improve the care of newborns with infections.
Gender
ALL
Eligibility 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.
About Shandong University
Shandong University is a prestigious research institution located in Jinan, China, renowned for its commitment to advancing medical and scientific knowledge through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, the university fosters an environment conducive to groundbreaking studies that address critical healthcare challenges. Shandong University actively engages in clinical research to evaluate new therapies and interventions, contributing to the global body of medical literature and enhancing patient care. Its dedicated team of researchers and clinicians ensures adherence to the highest ethical standards and regulatory compliance, positioning the university as a key player in the field of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tianjin, Tianjin, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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