Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

Chulalongkorn University

Status: Completed

Conditions: Peritonitis

Treatments: Drug: ceftazidime+ciprofloxacin; Drug: cefazolin+gentamicin; Drug: cefazolin monotherapy; Drug: ceftazidime monotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01785641

RA56/006

Details and patient eligibility

About

To compare the efficacy of single versus combined antibiotic therapy for bacterial peritonitis in CAPD patients.

Full description

To compare relapse and recurrent rate of peritonitis between single and combined antibiotic regimens for bacterial peritonitis in CAPD patients.

Enrollment: 300 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 4 patient groups

ceftazidime+ciprofloxacin

Experimental group

Description:

2 synergistic antibiotics(ceftazidime IP and ciprofloxacin po for gram negative bacterial peritonitis)

Treatment:

Drug: ceftazidime+ciprofloxacin

ceftazidime monotherapy

Active Comparator group

Description:

ceftazidime IP for gram negative bacterial peritonitis

Treatment:

Drug: ceftazidime monotherapy

cefazolin+gentamicin

Experimental group

Description:

cefazolin IP and gentamicin IP for gram positive bacterial peritonitis

Treatment:

Drug: cefazolin+gentamicin

cefazolin monotherapy

Active Comparator group

Description:

cefazolin IP for gram positive bacterial peritonitis

Treatment:

Drug: cefazolin monotherapy