Exploring different dosing schedules of Ceftazidime/Avibactam for severe infections
Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes in Patients With Severe Infection: a Multicenter, Prospective, Randomized Controlled Study
PHASE4 · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT06528028
This study is testing if giving Ceftazidime/Avibactam in a different way can help people with severe infections caused by tough bacteria do better than the usual method.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06528028 on ClinicalTrials.gov |
What this trial studies
This study investigates the clinical efficacy of varying administration regimens of Ceftazidime/Avibactam (CAZ/AVI) in patients with severe infections caused by carbapenem-resistant Enterobacter. The main objective is to compare a loading dose followed by continuous infusion against the standard dosing regimen to determine which is more effective. Additionally, the study will analyze the relationship between dosing regimens, bacterial clearance, 28-day mortality, and adverse drug reactions. The findings aim to enhance the understanding of pharmacokinetics and pharmacodynamics in this context.
Who should consider this trial
Good fit: Ideal candidates include patients with severe infections caused by multiple-resistant bacteria that are sensitive to Ceftazidime/Avibactam.
Not a fit: Patients who are allergic to Ceftazidime/Avibactam or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with severe infections caused by resistant bacteria.
How similar studies have performed: While there have been studies on Ceftazidime/Avibactam, this specific approach to varying administration regimens is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Multiple-resistant negative bacteria Sensitive to ceftazidime/avibactam Received intravenous infusion of ceftazidime/avibactam Exclusion Criteria: Allergic to ceftazidime/avibactam Blood sample not be collected Pregnant or lactating
Where this trial is running
Nanjing, Jiangsu
- Intensive Care Unit, Drum Tower Hospital — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Principal investigator: Ying Xu, Ph.D — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study coordinator: Ying Xu, Ph.D
- Email: ctboycm@hotmail.com
- Phone: 0086+（025）83106666
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: Anti-Infective Agent