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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

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ClinicalTrials.gov Identifier: NCT02593201
Recruitment Status : Recruiting
First Posted : November 2, 2015
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Cheuk-Chun SZETO, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Peritoneal Dialysis Drug: Extended antibiotics (cefazolin or ceftazidime) Drug: Usual antibiotics (cefazolin or ceftazidime) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Actual Study Start Date : February 26, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Dialysis

Arm Intervention/treatment
Experimental: Treatment
One extra week of antibiotic therapy
Drug: Extended antibiotics (cefazolin or ceftazidime)
To continue with the existing effective antibiotic therapy for one extra week

Sham Comparator: Control
No extra antibiotics
Drug: Usual antibiotics (cefazolin or ceftazidime)
Usual duration of effective antibiotic therapy therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with peritoneal dialysis-related peritonitis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593201


Contacts
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Contact: Cheuk Chun Szeto, MD 852-26323878 ccszeto@cuhk.edu.hk
Contact: Bonnie CH Kwan, MBBS 852-26321558 bonniekwan@cuhk.edu.hk

Locations
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Hong Kong
Department of Medicine & Therapeutics, Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Mei-Shan Cheng, BN    852-26323528    cms439@ha.org.hk   
Contact: Man-Ching Law, BN    852-26323528    lmc794@ha.org.hk   
Sponsors and Collaborators
Chinese University of Hong Kong

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Responsible Party: Cheuk-Chun SZETO, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02593201     History of Changes
Other Study ID Numbers: PPDNA
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Cefazolin
Ceftazidime
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents