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

This study has been completed.

First Received on July 6, 2007. Last Updated on June 14, 2011 History of Changes

Sponsor:	Hospital Authority, Hong Kong
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00497744

Purpose

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.

Condition	Intervention
Peritonitis	Drug: Intraperitoneal Cefepime

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Research Study on the Pharmacokinetic Profile of Intraperitoneal Cefepime in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis

Resource links provided by NLM:

MedlinePlus related topics: Dialysis

Drug Information available for: Cefepime Cefepime hydrochloride

U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

Estimated Enrollment:	6
Study Start Date:	November 2005
Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497744

Locations

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

Sponsors and Collaborators

Hospital Authority, Hong Kong

Investigators

Principal Investigator:

Sze Kit Yuen, Dr

Department of Medicine and Geriatrics, Caritas Medical Centre

More Information

Additional Information:

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00497744 History of Changes
Other Study ID Numbers:	KW/EX/05-020, HARECCTR0500027
Study First Received:	July 6, 2007
Last Updated:	June 14, 2011
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

CAPD peritonitis
Peritoneal Dialysis, Continuous Ambulatory

Additional relevant MeSH terms:

Peritonitis
Peritoneal Diseases
Digestive System Diseases
Cefepime

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012