A Pharmacokinetic Study of Cefepime After Administration Into Dialysate in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis
Research Study on the Pharmacokinetic Profile of Intraperitoneal Cefepime in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis
2 other identifiers
observational
6
1 country
2
Brief Summary
Cefepime is a broad-spectrum antibiotic used in treating CAPD peritonitis. However, medical knowledge has been lacking with regard to its pharmacokinetic profile after it has been administered intraperitoneally. The current study aims at determining the drug level at different time after the drug has been added into the peritoneal fluid in patients with CAPD peritonitis. The results of this study will finally leads to rational prescription of this drug at correct dosages.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2005
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 6, 2007
CompletedFirst Posted
Study publicly available on registry
July 9, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJune 16, 2011
June 1, 2011
July 6, 2007
June 14, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
4 males and 2 females, of age 57.83 +/-11.63 years with urinary creatinine clearance of 0.87+/-2.06ml/min/1.73m2 and admitted for CAPD peritonitis were enrolled. After collection of peritoneal dialysate for cell count and microbiological work-up, all subjects were loaded with 2g cefepime IP and dwelled for 6 hours. This was followed by 250mg cefepime in each subsequent 6-hourly peritoneal dialysis exchange. Plasma cefepime levels were determined at time 0, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120 hrs. Pharmacokinetic analyses were then performed.
You may qualify if:
- Age \>= 18 years \& has been put on CAPD for \>= 4 weeks before entering into the study
You may not qualify if:
- Known hypersensitivity to cefepime or other cephalosporin; CAPD peritonitis \<= 28 days before being enrolled into the study
- Antibiotic treatment within 1 week prior to entry into the study
- Severe exit site or tunnel infection on the day of presentation
- Any conditions that prompt early removal of Tenckhoff catheter irrespective of clinical response to antibiotic treatment
- Abdominal malignancy; Any surgical causes of peritonitis
- Suspected or known fungal or tuberculous peritonitis
- History of dementia or known mental incompetency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Caritas Medical Centre
Hong Kong, China
Princess Margaret Hospital
Hong Kong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sze Kit Yuen, Dr
Department of Medicine and Geriatrics, Caritas Medical Centre
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
July 6, 2007
First Posted
July 9, 2007
Study Start
November 1, 2005
Study Completion
December 1, 2007
Last Updated
June 16, 2011
Record last verified: 2011-06