Observing how ceftazidime avitbatan sodium works in children with severe infections
Pharmacokinetics and Pharmacodynamics of Ceftazidime Avitbatan Sodium in Children With Severe Infection
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 3 Months to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04961580 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children admitted to the pediatric intensive care unit who are receiving ceftazidime avitbatan sodium.
Not a fit: Patients who have not signed informed consent or are participating in other clinical trials may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
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.