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CompletedNCT01785641Updated Feb 21, 2024

Single Versus Combined Antibiotic Therapy for Bacterial Peritonitis in CAPD Patients

An interventional study of ceftazidime+ciprofloxacin and ceftazidime monotherapy in Peritonitis, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-21.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
15 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Peritonitis

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Keywords

  • peritoneal dialysis
  • peritonitis
03

In context

Peritonitis

167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.

This study's enrollment of 300 is above the median of 79 across 106 interventional studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.

Browse Chulalongkorn University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    ceftazidime+ciprofloxacin

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

    Drug: ceftazidime+ciprofloxacin

  • Active comparator
    ceftazidime monotherapy

    ceftazidime IP for gram negative bacterial peritonitis

    Drug: ceftazidime monotherapy

  • Experimental
    cefazolin+gentamicin

    cefazolin IP and gentamicin IP for gram positive bacterial peritonitis

    Drug: cefazolin+gentamicin

  • Active comparator
    cefazolin monotherapy

    cefazolin IP for gram positive bacterial peritonitis

    Drug: cefazolin monotherapy

Interventions

  • Drugceftazidime+ciprofloxacin

    Drug pages: Ceftazidime · Ciprofloxacin

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

    Also known as: combined antibiotic therapy

  • Drugceftazidime monotherapy

    ceftazidime IP for gram negative bacterial peritonitis

    Also known as: monotherapy

  • Drugcefazolin+gentamicin

    Drug pages: Cefazolin · Gentamicins

    cefazolin IP + gentamicin IP for gram positive bacterial peritonitis

    Also known as: combined antibiotic therapy

  • Drugcefazolin monotherapy

    cefazolin IP for gram positive bacterial peritonitis

    Also known as: monotherapy

06

What researchers measure

Primary outcomes

  1. relapse or recurrent rate

    Time frame: within 4 weeks after peritonitis treatment

07

Study locations

1 site
  • Chulalongkorn university
    Bangkok, 10330, Thailand
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2012 to primary completion in Dec 2013, 12 months.

Of 23 interventional studies with no phase under Peritonitis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2013
First posted
Feb 7, 2013
StartActual
Dec 2012
Primary completionActual
Dec 2013
CompletionActual
Dec 2013
Last update
Feb 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01785641
Lead sponsor
Chulalongkorn University
Responsible party
Sponsor
First posted
Feb 7, 2013
Start date
Dec 2012
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Feb 21, 2024

Study contacts

Nalinee Saiprasertkit, MD.
principal investigator · Chulalongkorn University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Ceftazidime · Ciprofloxacin · Cefazolin · Gentamicins

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