Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

NCT ID: NCT01785641

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ceftazidime+ciprofloxacin

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

Group Type EXPERIMENTAL

ceftazidime+ciprofloxacin

Intervention Type DRUG

2 synergistic antibiotics: ceftazidime IP + ciprofloxacin po for gram negative bacterial peritonitis

ceftazidime monotherapy

ceftazidime IP for gram negative bacterial peritonitis

Group Type ACTIVE_COMPARATOR

ceftazidime monotherapy

Intervention Type DRUG

ceftazidime IP for gram negative bacterial peritonitis

cefazolin+gentamicin

cefazolin IP and gentamicin IP for gram positive bacterial peritonitis

Group Type EXPERIMENTAL

cefazolin+gentamicin

Intervention Type DRUG

cefazolin IP + gentamicin IP for gram positive bacterial peritonitis

cefazolin monotherapy

cefazolin IP for gram positive bacterial peritonitis

Group Type ACTIVE_COMPARATOR

cefazolin monotherapy

Intervention Type DRUG

cefazolin IP for gram positive bacterial peritonitis

Interventions

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ceftazidime+ciprofloxacin

2 synergistic antibiotics: ceftazidime IP + ciprofloxacin po for gram negative bacterial peritonitis

Intervention Type DRUG

ceftazidime monotherapy

ceftazidime IP for gram negative bacterial peritonitis

Intervention Type DRUG

cefazolin+gentamicin

cefazolin IP + gentamicin IP for gram positive bacterial peritonitis

Intervention Type DRUG

cefazolin monotherapy

cefazolin IP for gram positive bacterial peritonitis

Intervention Type DRUG

Other Intervention Names

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combined antibiotic therapy monotherapy combined antibiotic therapy monotherapy

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nalinee Saiprasertkit, MD.

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Chulalongkorn university

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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RA56/006

Identifier Type: -

Identifier Source: org_study_id

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