Observing how ceftazidime avitbatan sodium works in children with severe infections
Official title: Pharmacokinetics and Pharmacodynamics of Ceftazidime Avitbatan Sodium in Children With Severe Infection
Run by Children's Hospital of Fudan University · NCT04961580 · Data updated 2026-11-12
This study looks at how well the antibiotic ceftazidime avitbatan sodium works in children with severe infections to see how it behaves in their bodies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Months to 18 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | October 1, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT04961580 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children admitted to the pediatric intensive care unit who are receiving ceftazidime avitbatan sodium.
✕Probably not a fit
Patients who have not signed informed consent or are participating in other clinical trials 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 focuses on children with severe infections who are receiving ceftazidime avitbatan sodium, a broad-spectrum antibiotic. It aims to analyze the pharmacokinetics and pharmacodynamics of the drug, particularly in the context of severe sepsis and extracorporeal life support. Blood samples will be collected at various time points to assess drug concentration and its effectiveness in treating severe infections. The study does not interfere with the normal treatment schedule of the patients and does not involve a control group.
Why it matters
Potential benefit: If successful, this study could enhance the treatment protocols for severe sepsis in pediatric patients, leading to better outcomes.
How similar studies have gone: While this study is observational and focuses on a specific antibiotic, similar studies have shown promise in understanding pharmacokinetics in pediatric populations, though this specific approach may be novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children who are admitted in the pediatric intensive care unit receiving ceftazidime avitbatan sodium Exclusion Criteria: * No Informed Consent signed * Participate in other clinical trials
Where it's running
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Children's hosptial of fudan university
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Guoping Lu, doctor — Children's Hospital of Fudan University
- Study coordinator: Yixue Wang, Doctor
- Email: yixuewang08@aliyun.com
- Phone: 8613524669352
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.