Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

This study is currently recruiting participants.
Verified February 2013 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01785641
First received: January 30, 2013
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
Peritonitis
Drug: ceftazidime+ciprofloxacin
Drug: ceftazidime monotherapy
Drug: cefazolin+gentamicin
Drug: cefazolin monotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in Continuous Ambulatory Peritoneal Dialysis Patients

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • relapse or recurrent rate [ Time Frame: within 4 weeks after peritonitis treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ceftazidime+ciprofloxacin
2 synergistic antibiotics(ceftazidime IP and ciprofloxacin po for gram negative bacterial peritonitis)
Drug: ceftazidime+ciprofloxacin
2 synergistic antibiotics: ceftazidime IP + ciprofloxacin po for gram negative bacterial peritonitis
Other Name: combined antibiotic therapy
Active Comparator: ceftazidime monotherapy
ceftazidime IP for gram negative bacterial peritonitis
Drug: ceftazidime monotherapy
ceftazidime IP for gram negative bacterial peritonitis
Other Name: monotherapy
Experimental: cefazolin+gentamicin
cefazolin IP and gentamicin IP for gram positive bacterial peritonitis
Drug: cefazolin+gentamicin
cefazolin IP + gentamicin IP for gram positive bacterial peritonitis
Other Name: combined antibiotic therapy
Active Comparator: cefazolin monotherapy
cefazolin IP for gram positive bacterial peritonitis
Drug: cefazolin monotherapy
cefazolin IP for gram positive bacterial peritonitis
Other Name: monotherapy

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785641

Contacts
Contact: Talerngsak Kanjanabuch, Assoc. Prof. 662-2564321 ext 211 golfnephro@hotmail.com

Locations
Thailand
Chulalongkorn university Recruiting
Bangkok, Thailand, 10330
Contact: Nalinee Saiprasertkit, MD.    66865899700    nsaiprasertkit@gmail.com   
Principal Investigator: Nalinee Saiprasertkit, MD.         
Sub-Investigator: Worapot Treamtrakanpon, MD.         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Nalinee Saiprasertkit, MD. Chulalongkorn University
  More Information

No publications provided

Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01785641     History of Changes
Other Study ID Numbers: RA56/006
Study First Received: January 30, 2013
Last Updated: February 6, 2013
Health Authority: Thailand: Institutional Review Board

Keywords provided by Chulalongkorn University:
peritoneal dialysis
peritonitis

Additional relevant MeSH terms:
Peritonitis
Peritoneal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Cefazolin
Ceftazidime
Gentamicins
Antibiotics, Antitubercular
Ciprofloxacin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014