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Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

Primary Purpose

Peritonitis

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
ceftazidime+ciprofloxacin
ceftazidime monotherapy
cefazolin+gentamicin
cefazolin monotherapy
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritonitis focused on measuring peritoneal dialysis, peritonitis

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Chulalongkorn universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

ceftazidime+ciprofloxacin

ceftazidime monotherapy

cefazolin+gentamicin

cefazolin monotherapy

Arm Description

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

ceftazidime IP for gram negative bacterial peritonitis

cefazolin IP and gentamicin IP for gram positive bacterial peritonitis

cefazolin IP for gram positive bacterial peritonitis

Outcomes

Primary Outcome Measures

relapse or recurrent rate

Secondary Outcome Measures

Full Information

First Posted
January 30, 2013
Last Updated
February 6, 2013
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01785641
Brief Title
Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients
Official Title
Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in Continuous Ambulatory Peritoneal Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the efficacy of single versus combined antibiotic therapy for bacterial peritonitis in CAPD patients.
Detailed Description
To compare relapse and recurrent rate of peritonitis between single and combined antibiotic regimens for bacterial peritonitis in CAPD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis
Keywords
peritoneal dialysis, peritonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ceftazidime+ciprofloxacin
Arm Type
Experimental
Arm Description
2 synergistic antibiotics(ceftazidime IP and ciprofloxacin po for gram negative bacterial peritonitis)
Arm Title
ceftazidime monotherapy
Arm Type
Active Comparator
Arm Description
ceftazidime IP for gram negative bacterial peritonitis
Arm Title
cefazolin+gentamicin
Arm Type
Experimental
Arm Description
cefazolin IP and gentamicin IP for gram positive bacterial peritonitis
Arm Title
cefazolin monotherapy
Arm Type
Active Comparator
Arm Description
cefazolin IP for gram positive bacterial peritonitis
Intervention Type
Drug
Intervention Name(s)
ceftazidime+ciprofloxacin
Other Intervention Name(s)
combined antibiotic therapy
Intervention Description
2 synergistic antibiotics: ceftazidime IP + ciprofloxacin po for gram negative bacterial peritonitis
Intervention Type
Drug
Intervention Name(s)
ceftazidime monotherapy
Other Intervention Name(s)
monotherapy
Intervention Description
ceftazidime IP for gram negative bacterial peritonitis
Intervention Type
Drug
Intervention Name(s)
cefazolin+gentamicin
Other Intervention Name(s)
combined antibiotic therapy
Intervention Description
cefazolin IP + gentamicin IP for gram positive bacterial peritonitis
Intervention Type
Drug
Intervention Name(s)
cefazolin monotherapy
Other Intervention Name(s)
monotherapy
Intervention Description
cefazolin IP for gram positive bacterial peritonitis
Primary Outcome Measure Information:
Title
relapse or recurrent rate
Time Frame
within 4 weeks after peritonitis treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Talerngsak Kanjanabuch, Assoc. Prof.
Phone
662-2564321
Ext
211
Email
golfnephro@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nalinee Saiprasertkit, MD.
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chulalongkorn university
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nalinee Saiprasertkit, MD.
Phone
66865899700
Email
nsaiprasertkit@gmail.com
First Name & Middle Initial & Last Name & Degree
Nalinee Saiprasertkit, MD.
First Name & Middle Initial & Last Name & Degree
Worapot Treamtrakanpon, MD.

12. IPD Sharing Statement

Learn more about this trial

Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

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