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

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ClinicalTrials.gov Identifier: NCT02787057
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Dong Jie, 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.

Condition or disease Intervention/treatment Phase
Peritoneal Dialysis Associated Peritonitis Drug: vancomycin Drug: moxifloxacin Drug: ceftazidime Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016


Arm Intervention/treatment
Experimental: 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.
Drug: vancomycin
IP vancomycin 1g every 5 days

Drug: ceftazidime
IP ceftazidime 1g QD

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

Drug: moxifloxacin
oral moxifloxacin 400mg QD




Primary Outcome Measures :
  1. Complete cure rate [ Time Frame: 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 :
  1. Primary response rate [ Time Frame: 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

  2. Primary treatment failure rate [ Time Frame: 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

  3. Secondary treatment failure rate [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Dong Jie, Professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02787057    
Other Study ID Numbers: empirical schemes
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Moxifloxacin
Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Vancomycin
Ceftazidime
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs