Clinical trial
Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in Continuous Ambulatory Peritoneal Dialysis Patients
Name
RA56/006
Description
To compare the efficacy of single versus combined antibiotic therapy for bacterial peritonitis in CAPD patients.
Trial arms
Trial start
2012-12-01
Estimated PCD
2013-12-01
Trial end
2013-12-01
Status
Completed
Treatment
ceftazidime+ciprofloxacin
2 synergistic antibiotics: ceftazidime IP + ciprofloxacin po for gram negative bacterial peritonitis
Arms:
ceftazidime+ciprofloxacin
Other names:
combined antibiotic therapy
ceftazidime monotherapy
ceftazidime IP for gram negative bacterial peritonitis
Arms:
ceftazidime monotherapy
Other names:
monotherapy
cefazolin+gentamicin
cefazolin IP + gentamicin IP for gram positive bacterial peritonitis
Arms:
cefazolin+gentamicin
Other names:
combined antibiotic therapy
cefazolin monotherapy
cefazolin IP for gram positive bacterial peritonitis
Arms:
cefazolin monotherapy
Other names:
monotherapy
Size
300
Primary endpoint
relapse or recurrent rate
within 4 weeks after peritonitis treatment
Eligibility criteria
Inclusion Criteria:
* age \>/= 18 years old
* ESRD patients on continuous ambulatory peritoneal dialysis more than 4 weeks
* presence of symptom or sign of peritonitis
* presence of WBC \>100cell/mm3 with PMN \>50% in peritoneal dialysate or gram stain positive for gram positive or gram negative bacteria
Exclusion Criteria:
* presence of polymicrobial organism, non-fermentative gram negative organism, fungus, mycobacteria in peritoneal fluid or culture-negative
* peritonitis from the organisms that required combined antibiotic therapy according to ISPD guideline 2010
* hospital-acquired peritonitis
* presence of catheter-related infection
* history of peritonitis within 4 weeks
* currently taking antibiotic
* allergic to the antibiotic that used in the study(penicillin or cephalosporin or quinolone or aminoglycoside)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 300, 'type': 'ACTUAL'}}
Updated at
2024-02-21
1 organization
4 products
1 indication
Organization
Chulalongkorn UniversityProduct
ceftazidime+ciprofloxacinIndication
PeritonitisProduct
CeftazidimeProduct
cefazolin+gentamicinProduct
Cefazolin