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

The Chinese University of Hong Kong

Status and phase: Completed; Phase 4

Conditions: Peritoneal Dialysis

Treatments: Drug: Extended antibiotics (cefazolin or ceftazidime); Drug: Usual antibiotics (cefazolin or ceftazidime)

Study type: Interventional

Funder types: Other

Identifiers

NCT02593201

PPDNA

Details and patient eligibility

About

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.

Enrollment: 358 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with peritoneal dialysis-related peritonitis

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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358 participants in 2 patient groups

Treatment

Experimental group

Description:

One extra week of antibiotic therapy

Treatment:

Drug: Extended antibiotics (cefazolin or ceftazidime)

Control

Sham Comparator group

Description:

No extra antibiotics

Treatment:

Drug: Usual antibiotics (cefazolin or ceftazidime)