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

Peking University

Status: Completed

Conditions: Peritoneal Dialysis Associated Peritonitis

Treatments: Drug: moxifloxacin; Drug: ceftazidime; Drug: vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02787057

empirical schemes

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Control group

Experimental group

Description:

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.

Treatment:

Drug: ceftazidime

Drug: vancomycin

study group

Active Comparator group

Description:

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

Treatment:

Drug: moxifloxacin

Drug: vancomycin