Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

February 20, 2024 updated by: Chulalongkorn University

Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in Continuous Ambulatory Peritoneal Dialysis Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
relapse or recurrent rate
Time Frame: within 4 weeks after peritonitis treatment
within 4 weeks after peritonitis treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Nalinee Saiprasertkit, MD., Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimated)

February 7, 2013

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA56/006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peritonitis

Clinical Trials on ceftazidime+ciprofloxacin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe