Trial Outcomes & Findings for Vancomycin Plus Moxifloxacin Versus Vancomycin Plus Ceftazidime for the Treatment of Peritoneal Dialysis (PD)-Related Peritonitis (NCT NCT02787057)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

within 4 weeks of completion of therapy

Results posted on

2020-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	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. vancomycin: IP vancomycin 1g every 5 days ceftazidime: IP ceftazidime 1g QD	Study Group 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
Overall Study NOT COMPLETED	0	0
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=40 Participants 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	Study Group n=40 Participants 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 n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Age, Continuous	58.0 years STANDARD_DEVIATION 15.7 • n=5 Participants	57.2 years STANDARD_DEVIATION 13.0 • n=7 Participants	57.6 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment China	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control Group n=40 Participants 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	Study Group n=40 Participants 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
Complete Cure Rate	32 Participants	31 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control Group n=40 Participants 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	Study Group n=40 Participants 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
Primary Response Rate	32 Participants	27 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control Group n=40 Participants 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	Study Group n=40 Participants 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
Primary Treatment Failure Rate	8 Participants	13 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control Group n=40 Participants 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	Study Group n=40 Participants 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
Secondary Treatment Failure Rate	5 Participants	4 Participants

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Study Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control Group n=40 participants at risk 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	Study Group n=40 participants at risk 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
Gastrointestinal disorders nausea	0.00% 0/40	2.5% 1/40 • Number of events 1
Skin and subcutaneous tissue disorders rash	2.5% 1/40 • Number of events 1	0.00% 0/40

Additional Information

Dr. Jie Dong

Peking University First Hospital

Phone: +86 010 66551708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place