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

NCT ID: NCT02593201

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-26
• Study Completion Date: 2019-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Treatment

One extra week of antibiotic therapy

Group Type: EXPERIMENTAL

Extended antibiotics (cefazolin or ceftazidime)

Intervention Type: DRUG

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

Control

No extra antibiotics

Group Type: SHAM_COMPARATOR

Usual antibiotics (cefazolin or ceftazidime)

Intervention Type: DRUG

Usual duration of effective antibiotic therapy therapy

Interventions

Extended antibiotics (cefazolin or ceftazidime)

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

Intervention Type: DRUG

Usual antibiotics (cefazolin or ceftazidime)

Usual duration of effective antibiotic therapy therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with peritoneal dialysis-related peritonitis

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Cheuk-Chun SZETO

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

PPDNA

Identifier Type: -

Identifier Source: org_study_id