Skip to main content
OpenTrials
Completed

NCT Number: NCT02593201

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with peritoneal dialysis-related peritonitis

Exclusion criteria

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

Treatment and study plan

Extended antibiotics (cefazolin or ceftazidime)

Drug

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

Usual antibiotics (cefazolin or ceftazidime)

Drug

Usual duration of effective antibiotic therapy therapy

Primary outcomes

  1. relapsing peritonitis episodes

    Time frame: 6 months

  2. repeat peritonitis episodes

    Time frame: 6 months

  3. recurrent peritonitis episodes

    Time frame: 6 months

Secondary outcomes

  1. peritonitis that requires hospitalization

    Time frame: 6 months

  2. need of catheter removal

    Time frame: 6 months

    by record review

  3. need of conversion to long-term hemodialysis

    Time frame: 6 months

    by record review

  4. death due to peritonitis

    Time frame: 6 months

  5. all cause mortality

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Nov 2, 2015
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.