Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Cefepime Versus Cefazolin Plus Ceftazidime for CAPD-associated 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: NCT02872038
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : October 31, 2017
Sponsor:
Collaborators:
The Kidney Foundation of Thailand
Siam Pharmaceutical Co Ltd
Information provided by (Responsible Party):
Thidarat Kitrungphaiboon, MD, Chulalongkorn University

Brief Summary:
The purpose of this study is to compare the efficacy of empirical antibiotics of CAPD-associated peritonitis with intraperitoneal, continuous dosing of cefepime monotherapy versus combination of cefazolin and ceftazidime. Patients were randomized to be administered either intraperitoneal cefepime 1 g loading then 250 mg all exchanges (treatment group) or cefazolin and ceftazidime (control group) in the same dose.

Condition or disease Intervention/treatment Phase
Peritoneal Dialysis Associated Peritonitis Drug: Cefepime Drug: Cefazolin plus Ceftazidime Phase 4

Detailed Description:

The International Society of Peritoneal Dialysis (ISPD) guideline suggest to use combination of antibiotics to cover both of gram positive and gram negative bacteria. The usual regimen in Thailand is cefazolin plus ceftazidime. Despite combination therapy, monotherapy is also possible for empirical treatment of CAPD-associated peritonitis since it helps to lowering staff burden and lowering risk of contamination. Cefepime could be an ideal antibiotic for empirical treatment of CAPD-associated peritonitis as it is an extended-spectrum cephalosporin, forth generation, covering most of gram positive and gram negative bacteria. In addition, cefepime is not broken down by many of the beta-lactamases and less beta-lactamases inducer. This study aims to prove the noninferiority of cefepime monotherapy to cefazolin plus ceftazidime for empirical treatment of CAPD-associated peritonitis.

CAPD-associated peritonitis was diagnosed by at least two of the following criteria: abdominal pain or cloudy peritoneal dialysis fluid (PDF); PDF white cell count > 100/μL with > 50% polymorphonuclear(PMN); and positive gram stain or culture. The patients were randomized into two groups by block of four randomization, sealed envelope. Treatment group was treated with intraperitoneal (IP) cefepime 1 g loading following by maintenance dose 250 mg IP all exchanges. Control group was treated with cefazolin 1 g IP loading and ceftazidime 1 g IP loading following by maintenance dose of cefazolin and ceftazidime 250 mg IP all exchanges. If a patient had residual urine ≥ 100 ml/day, dose of antibiotics would be increased by 25%.

On the first day, the initial blood tests for complete blood count, electrolyte, BUN, creatinine, calcium, phosphate and magnesium were obtained. While peritoneal dialysis fluid were collected using two methods of bacterial culture, both of centrifugation of 50 ml peritoneal dialysis fluid at 3,000 g for 15 minutes and bedside 5-10 ml of peritoneal dialysis fluid inoculated into the blood culture bottles. PDF gram stain and bacterial culture were done. The patients were followed on day 3, 5, 10, 14, 21 and 28 days after the completion of antibiotic course. If clinical improved, the antibiotics would be adjusted according to the culture result and sensitivity after day 5. If clinical not improved the antibiotics would be step up and Tenckhoff catheter removal was considered (on any day of treatment). The patients were treated at least 14 days or 21 days depend on the culture result (as the recommendation of ISPD guideline 2010).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled Trial Comparing Cefepime Monotherapy Versus Combination of Cefazolin Plus Ceftazidime for Empirical Treatment of CAPD-associated Peritonitis
Study Start Date : August 2015
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Cefepime intraperitoneal continuous dosing
Drug: Cefepime
Cefepime intraperitoneal continuous dosing

Active Comparator: Control
Cefazolin plus Ceftazidime intraperitoneal continuous dosing
Drug: Cefazolin plus Ceftazidime
Other Name: Control group




Primary Outcome Measures :
  1. Primary response rate [ Time Frame: day 10 of treatment ]
    Resolution of clinical peritonitis and peritoneal dialysis fluid WBC < 100 /μL with PMN < 50% at day 10


Secondary Outcome Measures :
  1. Initial response rate [ Time Frame: day 5 of treatment ]
    Resolution of clinical peritonitis and peritoneal dialysis fluid WBC < 100 /μL with PMN < 50% at day 5


Other Outcome Measures:
  1. Complete cure rate [ Time Frame: 28 days after completion of antibiotics ]
    Complete resolution without relapse or recurrent within 28 days after completion of antibiotics.

  2. Relapse peritonitis rate [ Time Frame: 28 days after completion antibiotics ]
    Recur of peritonitis with the same organism or sterile culture within 28 days after completion antibiotics

  3. Recurrent peritonitis rate [ Time Frame: 28 days after completion antibiotics ]
    Recur of peritonitis with different organism within 28 days after completion antibiotics

  4. Death rate [ Time Frame: 28 days after completion antibiotics ]
    Death from any cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age more than 18 years
  • CAPD initiation more than 4 weeks

Exclusion Criteria:

  • Exit site or tunnel infection
  • Sepsis
  • Previous CAPD-associated peritonitis treatment within 4 weeks
  • Drug allergy to cephalosporin
  • Tenckhoff catheter malfunction
  • Hospitalization more than 48 hours
  • Fungal or Mycobacterium infection
  • Suspected secondary peritonitis
  • Concomitant antibiotics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872038


Locations
Layout table for location information
Thailand
Chulalongkorn University
Bangkok, Thailand, 10500
Sponsors and Collaborators
Chulalongkorn University
The Kidney Foundation of Thailand
Siam Pharmaceutical Co Ltd

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Thidarat Kitrungphaiboon, MD, Fellow of Nephrology, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02872038    
Other Study ID Numbers: MONOCEF
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Cefazolin
Ceftazidime
Cefepime
Anti-Bacterial Agents
Anti-Infective Agents