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NCT01785641 Clinical Trial

Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

Peritonitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01785641
Other study ID # RA56/006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2012
Est. completion date December 2013

Study information
Verified date February 2013
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 15 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ceftazidime+ciprofloxacin
2 synergistic antibiotics: ceftazidime IP + ciprofloxacin po for gram negative bacterial peritonitis
• ceftazidime monotherapy
ceftazidime IP for gram negative bacterial peritonitis
• cefazolin+gentamicin
cefazolin IP + gentamicin IP for gram positive bacterial peritonitis
• cefazolin monotherapy
cefazolin IP for gram positive bacterial peritonitis

Locations
Country Name City State
Thailand Chulalongkorn university Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary relapse or recurrent rate within 4 weeks after peritonitis treatment
See also
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Active, not recruiting NCT02755610 - Check List to Improve Patient Self-care and Product Defect Report in Continuous Ambulatory Peritoneal Dialysis N/A
Not yet recruiting NCT05308849 - Peritoneal Diffusion and Efficacy of Antibiotic Therapy in Pediatric Peritonitis N/A
Completed NCT02726932 - Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery
Recruiting NCT05050253 - Lavage With Super-Oxidized Solution for Secondary Peritonitis N/A
Completed NCT02926846 - IV Antibiotics With Lavage for Severe PD Peritonitis Phase 4