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

NCT ID: NCT02787057

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-04-30

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.

Detailed Description

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.

Conditions

Peritoneal Dialysis Associated Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: EXPERIMENTAL

vancomycin

Intervention Type: DRUG

IP vancomycin 1g every 5 days

ceftazidime

Intervention Type: DRUG

IP ceftazidime 1g QD

study group

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

Group Type: ACTIVE_COMPARATOR

vancomycin

Intervention Type: DRUG

IP vancomycin 1g every 5 days

moxifloxacin

Intervention Type: DRUG

oral moxifloxacin 400mg QD

Interventions

vancomycin

IP vancomycin 1g every 5 days

Intervention Type: DRUG

moxifloxacin

oral moxifloxacin 400mg QD

Intervention Type: DRUG

ceftazidime

IP ceftazidime 1g QD

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong Jie

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

empirical schemes

Identifier Type: -

Identifier Source: org_study_id