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Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

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ClinicalTrials.gov Identifier: NCT01785641
Recruitment Status : Unknown
Verified February 2013 by Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University

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

Condition or disease Intervention/treatment Phase
Peritonitis Drug: ceftazidime+ciprofloxacin Drug: ceftazidime monotherapy Drug: cefazolin+gentamicin Drug: cefazolin monotherapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in Continuous Ambulatory Peritoneal Dialysis Patients
Study Start Date : December 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 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




Primary Outcome Measures :
  1. relapse or recurrent rate [ Time Frame: within 4 weeks after peritonitis treatment ]


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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01785641     History of Changes
Other Study ID Numbers: RA56/006
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Chulalongkorn University:
peritoneal dialysis
peritonitis

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