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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00497744
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : June 16, 2011
Sponsor:
Information provided by:
Hospital Authority, Hong Kong

Tracking Information
First Submitted Date July 6, 2007
First Posted Date July 9, 2007
Last Update Posted Date June 16, 2011
Study Start Date November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Pharmacokinetic Study of Cefepime After Administration Into Dialysate in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis
Official Title Research Study on the Pharmacokinetic Profile of Intraperitoneal Cefepime in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Peritonitis
Intervention Drug: Intraperitoneal Cefepime
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: July 27, 2010)
6
Original Estimated Enrollment
 (submitted: July 6, 2007)
5
Actual Study Completion Date December 2007
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT00497744
Other Study ID Numbers KW/EX/05-020
HARECCTR0500027
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Hospital Authority, Hong Kong
Collaborators Not Provided
Investigators
Principal Investigator: Sze Kit Yuen, Dr Department of Medicine and Geriatrics, Caritas Medical Centre
PRS Account Hospital Authority, Hong Kong
Verification Date June 2011