Skip to main content
OpenTrials
Completed

NCT Number: NCT02787057

Vancomycin Plus Moxifloxacin Versus Vancomycin Plus Ceftazidime for the Treatment of Peritoneal Dialysis (PD)-Related Peritonitis

Intra-peritoneal administration of antibiotics covering both gram-positive and gram-negative organisms was recommended as first-line regimen for the management of peritoneal dialysis related peritonitis. Oral administration of quinolones can also achieve effective serum concentrations, and is more convenient and economical. We conducted a pilot randomized controlled study to compare the effects on peritonitis cure and relapsing rates between oral moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peritoneal Dialysis Associated Peritonitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

To compare the effects on peritonitis cure and relapsing rates between oral moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime, eligible PD patients were randomly assigned to study group (IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD) and control group (IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD). Patients were followed for 3 months after the completion of the treatment period. Primary endpoint is complete cure, secondary endpoint are primary response and primary or secondary treatment failure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • incident or prevalent peritoneal dialysis patients
  • diagnosis of acute peritonitis according to ISPD guideline
  • age >18 years

Exclusion criteria

  • receiving antibiotic treatment for other reasons when peritonitis occurred
  • contraindication to cephalosporin, vancomycin, or fluoroquinolones
  • concomitant exit-site or tunnel infection
  • requirement for immediate transfer to hemodialysis due to sepsis, gastrointestinal perforation or visceral inflammation, severe bowel obstruction, or ultrafiltration failure at the initiation of peritonitis
  • inability to tolerate oral administration due to severe gastrointestinal complication or other reasons
  • history of psychological illness or condition which interfered with ability to understand or comply with the requirements of the study
  • pregnant or breast-feeding

Treatment and study plan

Vancomycin

Drug

IP vancomycin 1g every 5 days

moxifloxacin

Drug

oral moxifloxacin 400mg QD

ceftazidime

Drug

IP ceftazidime 1g QD

Primary outcomes

  1. Complete Cure Rate

    Time frame: within 4 weeks of completion of therapy

    complete cure was defined as complete resolution of peritonitis (normalization of body temperature, resolution of abdominal pain, clearing of dialysate, and PD effluent neutrophil count less than 100 cells/mL and proportion of polynuclear cell less than 50%) by using antibiotics alone without relapse within 4 weeks of completion of therapy

Secondary outcomes

  1. Primary Response Rate

    Time frame: on day 10 by using antibiotics alone

    Primary response was defined as resolution of peritonitis (normalization of body temperature, resolution of abdominal pain, clearing of dialysate, and PD effluent neutrophil count less than 100 cells/mL and proportion of polynuclear cell less than 50%) on day 10 by using antibiotics alone

  2. Primary Treatment Failure Rate

    Time frame: after 3 days of treatment by the assigned antibiotics

    Primary treatment failure was defined as the presence of fever, abdominal pain, and turbid peritoneal dialysate, and if the total peritoneal WBC counts is >50% of the pretreatment values after 3 days of treatment by the assigned antibiotics

  3. Secondary Treatment Failure Rate

    Time frame: after 6 to 8 days of treatment

    Secondary treatment failure was defined as treatment failure despite adjustment of antibiotics or changing to second line antibiotics for 3 to 5 days in patients with primary treatment failure

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Intraperitoneal (IP) Vancomycin Plus Oral Moxifloxacin Versus IP Vancomycin Plus IP Ceftazidime for the Treatment of Peritoneal Dialysis-related Peritonitis: a Pilot Randomized Controlled Study

Acronym: PD

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2016
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.