Peritoneal Dialysis Associated Peritonitis Clinical Trial
Official title:
A Multicenter, Randomized, Controlled Trial Comparing Cefepime Monotherapy Versus Combination of Cefazolin Plus Ceftazidime for Empirical Treatment of CAPD-associated Peritonitis
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.
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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02787057 -
Vancomycin Plus Moxifloxacin Versus Vancomycin Plus Ceftazidime for the Treatment of Peritoneal Dialysis (PD)-Related Peritonitis
|
N/A | |
| Completed |
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