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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 logo

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

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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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