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

June 14, 2011 updated by: Hospital Authority, Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Caritas Medical Centre
      • Hong Kong, China
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: Sze Kit Yuen, Dr, Department of Medicine and Geriatrics, Caritas Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

July 6, 2007

First Submitted That Met QC Criteria

July 6, 2007

First Posted (ESTIMATE)

July 9, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KW/EX/05-020
  • HARECCTR0500027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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