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

NCT02787057 | Completed Results

• 1 other identifier: empirical schemes
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peritoneal Dialysis Associated Peritonitis

Outcome Measures

Primary Outcomes (1)

• Complete Cure Rate

  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

  within 4 weeks of completion of therapy

Secondary Outcomes (3)

• Primary Response Rate

  on day 10 by using antibiotics alone

• Primary Treatment Failure Rate

  after 3 days of treatment by the assigned antibiotics

• Secondary Treatment Failure Rate

  after 6 to 8 days of treatment

Study Arms (2)

Control group

EXPERIMENTAL

IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD. The duration of treatment was based on internatinal society of peritoneal dialysis (ISPD) guideline recommendations.

Drug: vancomycin; Drug: ceftazidime

study group

ACTIVE COMPARATOR

IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.

Drug: vancomycin; Drug: moxifloxacin

Interventions

vancomycin DRUG

IP vancomycin 1g every 5 days

Control group; study group

moxifloxacin DRUG

oral moxifloxacin 400mg QD

study group

ceftazidime DRUG

IP ceftazidime 1g QD

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Interventions

Vancomycin; Moxifloxacin; Ceftazidime

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds

Results Point of Contact

• Title: Dr. Jie Dong
• Organization: Peking University First Hospital

jie.dong@bjmu.edu.cn

+86 010 66551708

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 1, 2016
• Study Start: November 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 26, 2020
• Results First Posted: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share