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Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Chulalongkorn University.
Recruitment status was:  Recruiting
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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785641

Locations
Thailand
Chulalongkorn university
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Nalinee Saiprasertkit, MD. Chulalongkorn University
  More Information

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
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Gentamicins
Cefazolin
Ceftazidime
Ciprofloxacin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 06, 2016