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

Not Applicable

Completed

• Conditions: Peritoneal Dialysis Associated Peritonitis
• Interventions: Drug: vancomycin; Drug: ceftazidime; Drug: moxifloxacin

• Registration Number: NCT02787057
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-06-01
• Status Verified: 2020-03
• Results First Submitted: 2020-03-11
• Results First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Results First Posted: 2020-03-26
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	vancomycin	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.
Control group	ceftazidime	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.
study group	moxifloxacin	IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.
study group	vancomycin	IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.

Primary Outcome Measures

Name	Time	Method
Complete Cure Rate	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 Outcome Measures

Name	Time	Method
Primary Response Rate	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
Primary Treatment Failure Rate	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
Secondary Treatment Failure Rate	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