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

Phase 4

Completed

• Conditions: Peritoneal Dialysis
• Interventions: Drug: Extended antibiotics (cefazolin or ceftazidime); Drug: Usual antibiotics (cefazolin or ceftazidime)

• Registration Number: NCT02593201
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-11-01
• Study Start: 2016-02-26
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

• Patients with peritoneal dialysis-related peritonitis

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Exclusion Criteria

• Patients with fungal peritonitis
• Patients with obvious surgical problems and require laparotomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Extended antibiotics (cefazolin or ceftazidime)	One extra week of antibiotic therapy
Control	Usual antibiotics (cefazolin or ceftazidime)	No extra antibiotics

Primary Outcome Measures

Name	Time	Method
repeat peritonitis episodes	6 months
relapsing peritonitis episodes	6 months
recurrent peritonitis episodes	6 months

Secondary Outcome Measures

Name	Time	Method
all cause mortality	6 months
peritonitis that requires hospitalization	6 months
need of catheter removal	6 months	by record review
need of conversion to long-term hemodialysis	6 months	by record review
death due to peritonitis	6 months

Trial Locations

Locations (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong