The Efficacy of Prolonged Antibiotic Therapy for the Prevention of Relapsing Peritonitis in Peritoneal Dialysis Patients With High Dialysis Effluent Bacterial DNA Fragment Levels

Study Overview
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Brief Summary
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Peritoneal dialysis (PD) is the first-line treatment of end stage renal disease (ESRD) in Hong Kong. Despite the advances in antibiotic therapy and connecting system, recurrent peritonitis remains the major cause of peritoneal failure. A recent study showed that an elevated bacterial DNA fragment levels in PD effluent 5 days prior to the completion of antibiotics predicts the development of relapsing or recurrent peritonitis episodes. We hypothesize that prolonged antibiotic therapy in PD patients with peritonitis and high PD effluent bacterial DNA fragment levels could prevent the development of relapsing and recurrent peritonitis. We plan to conduct a randomized control study of 360 patients with PD peritonitis. After inform consent, they will be randomized to receive one additional week of the effective antibiotic treatment (the Preemptive Treatment Group) or no additional treatment (the Control Group). Specimens of PD effluent will be collected 5 days prior to the completion of antibiotics for the measurement of bacterial DNA fragments. All patients will be followed for 6 months after completion of antibiotic therapy for the development of relapsing, recurrent, or repeat peritonitis episodes. Our study will determine the efficacy of a test-before-treat algorithm that could reduce the incidence of relapsing and recurrent peritonitis and, at the same time, minimize the unnecessary use of prolonged antibiotic treatment.

Conditions
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Peritoneal Dialysis

Intervention / Treatment
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* Drug: Extended antibiotics (cefazolin or ceftazidime)
* Drug: Usual antibiotics (cefazolin or ceftazidime)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with peritoneal dialysis-related peritonitis Exclusion Criteria: Patients with fungal peritonitis Patients with obvious surgical problems and require laparotomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>One extra week of antibiotic therapy | Drug: Extended antibiotics (cefazolin or ceftazidime)<br>* To continue with the existing effective antibiotic therapy for one extra week<br>|
| Sham Comparator: Control<br>No extra antibiotics | Drug: Usual antibiotics (cefazolin or ceftazidime)<br>* Usual duration of effective antibiotic therapy therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapsing peritonitis episodes |  | 6 months | 
| repeat peritonitis episodes |  | 6 months | 
| recurrent peritonitis episodes |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peritonitis that requires hospitalization |  | 6 months | 
| need of catheter removal | by record review | 6 months | 
| need of conversion to long-term hemodialysis | by record review | 6 months | 
| death due to peritonitis |  | 6 months | 
| all cause mortality |  | 6 months |