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

NCT02593201 | Completed Phase 4

• 1 other identifier: PPDNA
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis

Outcome Measures

Primary Outcomes (3)

• relapsing peritonitis episodes

  6 months

• repeat peritonitis episodes

  6 months

• recurrent peritonitis episodes

  6 months

Secondary Outcomes (5)

• peritonitis that requires hospitalization

  6 months

• need of catheter removal

  6 months

• need of conversion to long-term hemodialysis

  6 months

• death due to peritonitis

  6 months

• all cause mortality

  6 months

Study Arms (2)

Treatment

EXPERIMENTAL

One extra week of antibiotic therapy

Drug: Extended antibiotics (cefazolin or ceftazidime)

Control

SHAM COMPARATOR

No extra antibiotics

Drug: Usual antibiotics (cefazolin or ceftazidime)

Interventions

Extended antibiotics (cefazolin or ceftazidime) DRUG

To continue with the existing effective antibiotic therapy for one extra week

Treatment

Usual antibiotics (cefazolin or ceftazidime) DRUG

Usual duration of effective antibiotic therapy therapy

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with peritoneal dialysis-related peritonitis

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Interventions

Cefazolin; Ceftazidime

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephaloridine

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 2, 2015
• Study Start: February 26, 2016
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

HK (1)