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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02926846
Other study ID # 2013.201
Secondary ID
Status Completed
Phase Phase 4
First received October 1, 2016
Last updated January 29, 2018
Start date March 2014
Est. completion date January 2018

Study information

Verified date January 2018
Source Alice Ho Miu Ling Nethersole Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized controlled trial to evaluate whether a switch to intravenous antibiotics with adjunctive lavage can improve the outcome of severe peritoneal dialysis related peritonitis.


Description:

The standard treatment of peritoneal dialysis (PD) related peritonitis is intraperitoneal (IP) antibiotics. In severe cases not responding to the IP antibiotics treatment, timely Tenckhoff catheter removal is needed. There is no known adjunctive measure that can improve the clinical outcome of the patients suffering from severe PD peritonitis.

Based on the past experience in the investigators' center, switching IP to intravenous route of antibiotics administration, together with adjunctive lavage was proposed to improve the clinical outcome of severe PD peritonitis, in particular a possible improved catheter salvage rate. This method will be evaluated in the present clinical trial.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date January 2018
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Prevalent PD patients with age >= 18 years old suffering from PD peritonitis

- PD effluent white cell count >1090/mm2 on peritonitis day 3

- Lack of clinical response

- Informed consent available

Exclusion Criteria:

- PD peritonitis in association with exit site or tunnel infection

- Relapsing peritonitis (i.e. peritonitis caused by same organism within 4 weeks after completion of antibiotics therapy)

- Fungal peritonitis

- Mycobacterial peritonitis (both tuberculosis and non-tuberculosis species)

- Clinical suspicion of surgical peritonitis

- Penicillin- or cephalosporin allergy, that cefazolin and ceftazidime could not be used

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Intravenous vancomycin & gentamicin with adjunctive lavage
Intravenous vancomycin and gentamicin are administered, together with adjunctive lavage performed by automated peritoneal dialysis machine over 48 to 72 hours. (choice of antibiotic is adjusted in accordance with the microbiology report when available)
Intraperitoneal vancomycin & gentamicin
Intraperitoneal vancomycin and gentamicin are administered, with the usual continuous ambulatory peritoneal dialysis schedule maintained. (choice of antibiotic is adjusted in accordance with the microbiology report when available)

Locations

Country Name City State
Hong Kong Alice Ho Miu Ling Nethersole Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Alice Ho Miu Ling Nethersole Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peritoneal dialysate effluent (PDE) white cell count and bacterial culture PDE is monitored every 48 hours, until white cell count <100/mm3 and bacterial culture is negative; assessed up to 3 weeks
Primary Number of participants requiring Tenckhoff catheter removal Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment
Secondary Number of participants developing relapsing peritonitis All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment
Secondary Number of participants requiring hospitalization All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment
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