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

• Sponsor: Peking University First Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02787057
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Duration (Months): 41

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Nov 1, 2012
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking University First Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dong Jie, Professor, Peking University First Hospital
• ClinicalTrials.gov Identifier: NCT02787057
• Other Study ID Numbers: empirical schemes
• First Posted: Jun 1, 2016
• Last Update Posted: Mar 26, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Peritonitis; Moxifloxacin; Vancomycin; Ceftazidime

Study Results

Participant Flow

Arm/Group Title	Control Group	Study Group
Arm/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. vancomycin: IP vancomycin 1g every 5 days ceftazidime: IP ceftazidime 1g QD	IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations. vancomycin: IP vancomycin 1g every 5 days moxifloxacin: oral moxifloxacin 400mg QD
Period Title: Overall Study
STARTED	40	40
COMPLETED	40	40
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control Group	Study Group	Total
Arm/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. vancomycin: IP vancomycin 1g every 5 days ceftazidime: IP ceftazidime 1g QD	IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations. vancomycin: IP vancomycin 1g every 5 days moxifloxacin: oral moxifloxacin 400mg QD	Total of all reporting groups
Overall Participants	40	40	80
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	27 67.5%	28 70%	55 68.8%
>=65 years	13 32.5%	12 30%	25 31.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.0 (15.7)	57.2 (13.0)	57.6 (14.4)
Sex: Female, Male (Count of Participants)
Female	16 40%	15 37.5%	31 38.8%
Male	24 60%	25 62.5%	49 61.3%
Region of Enrollment (participants) [Number]
China	40 100%	40 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Complete Cure Rate
Description	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
Time Frame	within 4 weeks of completion of therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Study Group
Arm/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. vancomycin: IP vancomycin 1g every 5 days ceftazidime: IP ceftazidime 1g QD	IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations. vancomycin: IP vancomycin 1g every 5 days moxifloxacin: oral moxifloxacin 400mg QD
Measure Participants	40	40
Count of Participants [Participants]	32 80%	31 77.5%

2. Secondary Outcome

Title	Primary Response Rate
Description	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
Time Frame	on day 10 by using antibiotics alone

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Study Group
Arm/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. vancomycin: IP vancomycin 1g every 5 days ceftazidime: IP ceftazidime 1g QD	IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations. vancomycin: IP vancomycin 1g every 5 days moxifloxacin: oral moxifloxacin 400mg QD
Measure Participants	40	40
Count of Participants [Participants]	32 80%	27 67.5%

3. Secondary Outcome

Title	Primary Treatment Failure Rate
Description	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
Time Frame	after 3 days of treatment by the assigned antibiotics

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Study Group
Arm/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. vancomycin: IP vancomycin 1g every 5 days ceftazidime: IP ceftazidime 1g QD	IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations. vancomycin: IP vancomycin 1g every 5 days moxifloxacin: oral moxifloxacin 400mg QD
Measure Participants	40	40
Count of Participants [Participants]	8 20%	13 32.5%

4. Secondary Outcome

Title	Secondary Treatment Failure Rate
Description	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
Time Frame	after 6 to 8 days of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Study Group
Arm/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. vancomycin: IP vancomycin 1g every 5 days ceftazidime: IP ceftazidime 1g QD	IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations. vancomycin: IP vancomycin 1g every 5 days moxifloxacin: oral moxifloxacin 400mg QD
Measure Participants	40	40
Count of Participants [Participants]	5 12.5%	4 10%

Adverse Events

Arm/Group Title	Control Group		Study Group
Arm/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. vancomycin: IP vancomycin 1g every 5 days ceftazidime: IP ceftazidime 1g QD		IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations. vancomycin: IP vancomycin 1g every 5 days moxifloxacin: oral moxifloxacin 400mg QD
All Cause Mortality
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/40 (2.5%)		1/40 (2.5%)
Gastrointestinal disorders
nausea	0/40 (0%)	0	1/40 (2.5%)	1
Skin and subcutaneous tissue disorders
rash	1/40 (2.5%)	1	0/40 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.