NCT01785641

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

January 30, 2013

Last Update Submit

February 20, 2024

Conditions

Peritonitis

Keywords

peritoneal dialysisperitonitis

Outcome Measures

Primary Outcomes (1)

  • relapse or recurrent rate

    within 4 weeks after peritonitis treatment

Study Arms (4)

ceftazidime+ciprofloxacin

EXPERIMENTAL

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

Drug: ceftazidime+ciprofloxacin

ceftazidime monotherapy

ACTIVE COMPARATOR

ceftazidime IP for gram negative bacterial peritonitis

Drug: ceftazidime monotherapy

cefazolin+gentamicin

EXPERIMENTAL

cefazolin IP and gentamicin IP for gram positive bacterial peritonitis

Drug: cefazolin+gentamicin

cefazolin monotherapy

ACTIVE COMPARATOR

cefazolin IP for gram positive bacterial peritonitis

Drug: cefazolin monotherapy

Interventions

ceftazidime+ciprofloxacinDRUG

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

Also known as: combined antibiotic therapy
ceftazidime+ciprofloxacin
ceftazidime monotherapyDRUG

ceftazidime IP for gram negative bacterial peritonitis

Also known as: monotherapy
ceftazidime monotherapy
cefazolin+gentamicinDRUG

cefazolin IP + gentamicin IP for gram positive bacterial peritonitis

Also known as: combined antibiotic therapy
cefazolin+gentamicin
cefazolin monotherapyDRUG

cefazolin IP for gram positive bacterial peritonitis

Also known as: monotherapy
cefazolin monotherapy

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn university

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Study Officials

  • Nalinee Saiprasertkit, MD.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 7, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 21, 2024

Record last verified: 2013-02

Locations

TH(1)