NCT04367974

Clinical Pharmacokinetic Study of Ceftazidime and Cefazolin

Clinical Pharmacokinetic Study of Ceftazidime and Cefazolin in Treating CAPD-related Peritonitis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Peritoneal dialysis-related peritonitis is a common complication of peritoneal dialysis, which is the main cause of transfer from peritoneal dialysis to hemodialysis. Guidelines for International Society for peritoneal dialysis（ISPD）published in 2016 recommend that timely and adequate use of antibiotics is the most important part of treatment. Empiric treatment should be initiated as soon as possible after obtaining microbiological specimens，then adjust the antibiotics according to culture results and drug sensitivity of bacteria. Intraperitoneal antibiotic can ensure antibiotic concentrations at the local sites of the infection are maximized，however, in patients with renal failure, the investigators should pay attention to the nephrotoxicity caused by the reduction of renal excretion，being guided by Pharmacokinetic/ Pharmacodynamic Principle on antibiotic can develop dosing recommendations to optimize antibiotic efficacy and minimize toxicity. In this study, the investigators aim to detect the concentration of ceftazidime and cefazolin in CAPD patients，so as to analyze the pharmacokinetics parameters and evaluate the rationality of the treatment.

Detailed description

The dose of cefazolin and Ceftazidime co-administered were 20 mg /kg，they were given intraperitoneal twice daily in the first bag and the fourth bag for 5 days，and given 1g once daily in the fourth bag for 9 days. Total treatment duration was 2 weeks. At least 1-mL serum and 5-mL dialysate samples were collected at 1, 2, 4, 6, 10, 14 days after complete instillation of the first dialysis bag containing antibiotic into the peritoneal cavity. The samples were then centrifuged at 3,000 rpm, all study samples were stored frozen (-80℃) within 1 hour after collection.

Conditions

• CAPD-related Peritonitis

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-05-01
• Completion: 2022-05-01
• First posted: 2020-04-29
• Last updated: 2020-05-21

Locations

1 site across 1 country: China