drugset / Trial / NCT04126031
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
Non-randomizedSingle-groupOpen-labelBasic science
Summary
This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age. In Part A of the study all patients will receive a single dose of ceftazidime-avibactam. In Part B all patients will received multiple doses of ceftazidime-avibactam. Efficacy will be assessed in the infants and neonates receiving multiple doses of ceftazidime-avibactam.
Timeline
- Start
- 2020-01-14
- Primary completion
- 2022-12-30
- Completion
- 2022-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceftazidime | Small molecule | 20 mg/kg | Intravenous |
| Subject | Ceftazidime | Small molecule | 30 mg/kg | Intravenous |
| Subject | avibactam | Small molecule | 5 mg/kg | Intravenous |
| Subject | avibactam | Small molecule | 7.5 mg/kg | Intravenous |