NCT02872038

Brief Summary

The purpose of this study is to compare the efficacy of empirical antibiotics of CAPD-associated peritonitis with intraperitoneal, continuous dosing of cefepime monotherapy versus combination of cefazolin and ceftazidime. Patients were randomized to be administered either intraperitoneal cefepime 1 g loading then 250 mg all exchanges (treatment group) or cefazolin and ceftazidime (control group) in the same dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2015

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

August 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

July 25, 2016

Last Update Submit

October 30, 2017

Conditions

Peritoneal Dialysis Associated Peritonitis

Outcome Measures

Primary Outcomes (1)

  • Primary response rate

    Resolution of clinical peritonitis and peritoneal dialysis fluid WBC \< 100 /μL with PMN \< 50% at day 10

    day 10 of treatment

Secondary Outcomes (1)

  • Initial response rate

    day 5 of treatment

Other Outcomes (4)

  • Complete cure rate

    28 days after completion of antibiotics

  • Relapse peritonitis rate

    28 days after completion antibiotics

  • Recurrent peritonitis rate

    28 days after completion antibiotics

  • +1 more other outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Cefepime intraperitoneal continuous dosing

Drug: Cefepime

Control

ACTIVE COMPARATOR

Cefazolin plus Ceftazidime intraperitoneal continuous dosing

Drug: Cefazolin plus Ceftazidime

Interventions

CefepimeDRUG

Cefepime intraperitoneal continuous dosing

Treatment
Cefazolin plus CeftazidimeDRUG
Also known as: Control group
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 18 years
  • CAPD initiation more than 4 weeks

You may not qualify if:

  • Exit site or tunnel infection
  • Sepsis
  • Previous CAPD-associated peritonitis treatment within 4 weeks
  • Drug allergy to cephalosporin
  • Tenckhoff catheter malfunction
  • Hospitalization more than 48 hours
  • Fungal or Mycobacterium infection
  • Suspected secondary peritonitis
  • Concomitant antibiotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Bangkok, 10500, Thailand

Location

Related Publications (1)

  • Kitrungphaiboon T, Puapatanakul P, Chuengsaman P, Tiskajornsiri K, Halue G, Siribamrungwong M, Matayart S, Chongthanakorn K, Poonvivatchaikarn U, Boonyakrai C, Somboonsilp W, Katavetin P, Praditpornsilpa K, Eiam-Ong S, Johnson DW, Kanjanabuch T. Intraperitoneal Cefepime Monotherapy Versus Combination Therapy of Cefazolin Plus Ceftazidime for Empirical Treatment of CAPD-Associated Peritonitis: A Multicenter, Open-Label, Noninferiority, Randomized, Controlled Trial. Am J Kidney Dis. 2019 Nov;74(5):601-609. doi: 10.1053/j.ajkd.2019.05.011. Epub 2019 Jul 19.

    PMID: 31331757DERIVED

MeSH Terms

Interventions

CefepimeCefazolinCeftazidimeControl Groups

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCephaloridineEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow of Nephrology

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 18, 2016

Study Start

August 1, 2015

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations

TH(1)