Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

C

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

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

Trial contacts and locations

1

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Central trial contact

Talerngsak Kanjanabuch, Assoc. Prof.

Data sourced from clinicaltrials.gov

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