Clinical trial NCT02787057: Vancomycin Plus Moxifloxacin Versus Vancomycin Plus Ceftazidime for the Treatment of Peritoneal Dialysis (PD)-Related Peritonitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Dialysis Associated Peritonitis
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complete Cure Rate
timeFrame: within 4 weeks of completion of therapy
Secondary outcomes:
measure: Primary Response Rate
timeFrame: on day 10 by using antibiotics alone
measure: Primary Treatment Failure Rate
timeFrame: after 3 days of treatment by the assigned antibiotics
measure: Secondary Treatment Failure Rate
timeFrame: after 6 to 8 days of treatment
Other outcomes:
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