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 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593201
• Other study ID #: PPDNA
• Status: Completed
• Phase: Phase 4
• Start date: February 26, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with peritoneal dialysis-related peritonitis

Exclusion Criteria:

• Patients with fungal peritonitis

• Patients with obvious surgical problems and require laparotomy

Related Conditions & MeSH terms

• Peritoneal Dialysis

Intervention

Drug:
• Extended antibiotics (cefazolin or ceftazidime)
To continue with the existing effective antibiotic therapy for one extra week
• Usual antibiotics (cefazolin or ceftazidime)
Usual duration of effective antibiotic therapy therapy

Locations

Country	Name	City	State
Hong Kong	Department of Medicine & Therapeutics, Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapsing peritonitis episodes		6 months
Primary	repeat peritonitis episodes		6 months
Primary	recurrent peritonitis episodes		6 months
Secondary	peritonitis that requires hospitalization		6 months
Secondary	need of catheter removal	by record review	6 months
Secondary	need of conversion to long-term hemodialysis	by record review	6 months
Secondary	death due to peritonitis		6 months
Secondary	all cause mortality		6 months