PeritonitisPhase 4NCT02926846
IV Antibiotics With Lavage for Severe PD Peritonitis
A Phase 4 study testing Intravenous vancomycin & gentamicin with adjunctive lavage and Intraperitoneal vancomycin & gentamicin in people with Peritonitis and Kidney Failure, run by Alice Ho Miu Ling Nethersole Hospital at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis, Kidney Failure
- What is being tested?
- Intravenous vancomycin & gentamicin with adjunctive lavage and Intraperitoneal vancomycin & gentamicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2014to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial on Intravenous Antibiotics With Adjunctive Lavage for Severe Peritoneal-dialysis Related Peritonitis
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.
Read the detailed 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.
- Conditions
- Peritonitis, Kidney Failure
- Being tested
- Intravenous vancomycin & gentamicin with adjunctive lavage, Intraperitoneal vancomycin & gentamicin
- Keywords
- Peritoneal dialysis, Lavage
- Medical subject headings
- Peritonitis, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous vancomycin & gentamicin with adjunctive lavageDrug
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 & gentamicinDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Lavage arm | Experimental | Intravenous vancomycin \& gentamicin with adjunctive lavage Receives: Drug: Intravenous vancomycin & gentamicin with adjunctive lavage |
| Standard treatment arm | Active comparator | Intraperitoneal vancomycin \& gentamicin Receives: Drug: Intraperitoneal vancomycin & gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal dialysate effluent (PDE) white cell count and bacterial culture
Measured: PDE is monitored every 48 hours, until white cell count <100/mm3 and bacterial culture is negative; assessed up to 3 weeks
Number of participants requiring Tenckhoff catheter removal
Measured: Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment
Secondary outcomes (2)
Number of participants developing relapsing peritonitis
Measured: All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment
Number of participants requiring hospitalization
Measured: All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startMar 2014
- Primary completionNov 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alice Ho Miu Ling Nethersole Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Siu-Man Wong, Alice Ho Miu Ling Nethersole Hospital
- Investigators
- Siu-Man Wong, MBChB, FRCPC, Principal investigator, Alice Ho Miu Ling Nethersole Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926846
- Sponsor's protocol ID
- 2013.201
- Status last verified
- Jan 2018
- First submitted
- 1 Oct 2016
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial on Intravenous Antibiotics With Adjunctive Lavage for Severe Peritoneal-dialysis Related Peritonitis
- ClinicalTrials.gov ID
- NCT02926846
- Acronym / sponsor ID
- 2013.201
- Conditions
- Peritonitis, Kidney Failure
- Keywords
- Peritoneal dialysis, Lavage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Alice Ho Miu Ling Nethersole HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavage arm | Experimental | Drug: Intravenous vancomycin & gentamicin with adjunctive lavageIntravenous vancomycin \& gentamicin with adjunctive lavage |
| Standard treatment arm | Active comparator | Drug: Intraperitoneal vancomycin & gentamicinIntraperitoneal vancomycin \& gentamicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous vancomycin & gentamicin with adjunctive lavageIntravenous 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) | Drug | Lavage arm |
| Intraperitoneal vancomycin & gentamicinIntraperitoneal 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) | Drug | Standard treatment arm |
Primary outcome
Peritoneal dialysate effluent (PDE) white cell count and bacterial culture
Time frame: PDE is monitored every 48 hours, until white cell count <100/mm3 and bacterial culture is negative; assessed up to 3 weeks
Number of participants requiring Tenckhoff catheter removal
Time frame: Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment
2 secondary outcomes
Number of participants developing relapsing peritonitis
Time frame: All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment
Number of participants requiring hospitalization
Time frame: All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Peritonitis
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Complicated Diverticulitis, Acute Diverticulitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siu-Man Wong, MBChB, FRCPC principal investigator
Alice Ho Miu Ling Nethersole Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous vancomycin & gentamicin with adjunctive lavage and Intraperitoneal vancomycin & gentamicin in people with Peritonitis and Kidney Failure, run by Alice Ho Miu Ling Nethersole Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal dialysate effluent (PDE) white cell count and bacterial culture (time frame: PDE is monitored every 48 hours, until white cell count <100/mm3 and bacterial culture is negative; assessed up to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.