Comparing Cefepime Versus Cefazolin Plus Ceftazidime for CAPD-associated Peritonitis
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|ClinicalTrials.gov Identifier: NCT02872038|
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : October 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Dialysis Associated Peritonitis||Drug: Cefepime Drug: Cefazolin plus Ceftazidime||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Cefepime intraperitoneal continuous dosing
Cefepime intraperitoneal continuous dosing
Active Comparator: Control
Cefazolin plus Ceftazidime intraperitoneal continuous dosing
Drug: Cefazolin plus Ceftazidime
Other Name: Control group
- 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
- 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
- Complete cure rate [ Time Frame: 28 days after completion of antibiotics ]Complete resolution without relapse or recurrent within 28 days after completion of antibiotics.
- 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
- Recurrent peritonitis rate [ Time Frame: 28 days after completion antibiotics ]Recur of peritonitis with different organism within 28 days after completion antibiotics
- Death rate [ Time Frame: 28 days after completion antibiotics ]Death from any cause
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
|Bangkok, Thailand, 10500|