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

Peritoneal Dialysis Associated Peritonitis Clinical Trial

— PD  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787057
• Other study ID #: empirical schemes
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: April 2016

Study information

• Verified date: March 2020
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Dialysis Associated Peritonitis
• Peritonitis

Intervention

Drug:
• vancomycin
IP vancomycin 1g every 5 days
• moxifloxacin
oral moxifloxacin 400mg QD
• ceftazidime
IP ceftazidime 1g QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Primary Response Rate	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	on day 10 by using antibiotics alone
Secondary	Primary Treatment Failure Rate	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	after 3 days of treatment by the assigned antibiotics
Secondary	Secondary Treatment Failure Rate	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	after 6 to 8 days of treatment