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NCT00497744 Clinical Trial

A Pharmacokinetic Study of Cefepime After Administration Into Dialysate in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis

Peritonitis Clinical Trial

Official title:
Research Study on the Pharmacokinetic Profile of Intraperitoneal Cefepime in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00497744
Other study ID # KW/EX/05-020
Secondary ID HARECCTR0500027
Status Completed
Phase N/A
First received July 6, 2007
Last updated June 14, 2011
Start date November 2005
Est. completion date December 2007

Study information
Verified date June 2011
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age >= 18 years & has been put on CAPD for >= 4 weeks before entering into the study

Exclusion Criteria:

- 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Intraperitoneal Cefepime

Locations
Country Name City State
China Caritas Medical Centre Hong Kong
China Princess Margaret Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

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