Peritoneal Dialysis-related InfectionNCT05251584
Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection
A study testing Mupirocin and Gentamicin in people with Peritoneal Dialysis-related Infection, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
Peritoneal dialysis-related infection is a complication that leads to peritoneal dialysis catheter removal or patient death. The present study aimed to investigate peritoneal dialysis-related infection, causative pathogens resulting in topical 2% mupirocin ointments period compare with 0.1% gentamicin cream period. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peritoneal Dialysis-related Infection
- What is being tested?
- Mupirocin and Gentamicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2021to 31 May 2023
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 20 years
- End stage renal disease patients on peritoneal dialysis follow up at Phramongkutklao hospital's peritoneal dialysis clinic between January 1, 2021 to March 31, 2023
- Start peritoneal dialysis or follow up at Phramongkutklao hospital's peritoneal dialysis clinic at least 90 days before recruited
- Use topical mupirocin ointment for prevention of peritoneal dialysis-related infection between January 1, 2021 to December 31, 2021
- Can be used LINE application throughout the study
Who cannot join
- Allergy to gentamicin or components
- Previous systemic antibiotics use within 90 days before recruited
- Previous peritoneal dialysis-related infection within 28 days before recruited
- Immunosuppressants used
- Prospective follow up less than 2 months
- Don't sign informed consent
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Phramongkutklao Hospital
Ratchathewi, Bangkok, 10400
Ittaprach Yimsuk, PharmD, 097-237-4797, ittaprach.y@gmail.com
Pamila Tasanavipas, MD, 081-344-2383, pa_tass@hotmail.com
About this study
Official title: Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection Caused by Pseudomonas Aeruginosa
Peritoneal dialysis-related infection is a complication that leads to peritoneal dialysis catheter removal or patient death. The present study aimed to investigate peritoneal dialysis-related infection, causative pathogens resulting in topical 2% mupirocin ointments period compare with 0.1% gentamicin cream period. Rate of catheter removal, time to first peritoneal dialysis-related infection after apply gentamicin cream.
- Conditions
- Peritoneal Dialysis-related Infection
- Being tested
- Mupirocin, Gentamicin
- Keywords
- Peritoneal dialysis-related infection, Infectious peritonitis, Exit-site infection, Infection rate, Drug susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MupirocinDrug
Also called BACIDAL
Apply mupirocin ointments for prevention of peritoneal dialysis-related infection between 1 January 2021 to 31 December 2021
GentamicinDrug
Also called GENTREX
Apply gentamicin creams for prevention of peritoneal dialysis-related infection for 1 year start after 1 January 2022
| Study group | Role | What they receive |
|---|---|---|
| Mupirocin and Gentamicin | Experimental | 2% mupirocin ointments apply at exit-site once daily after wound cleaning before recruit in the study then use 0.1% gentamicin cream apply at exit-site once daily after wound cleaning after entry to the study. Receives: Drug: Mupirocin; Drug: Gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Exit-site infection in mupirocin compared with gentamicin group
Exit-site infection diagnosis by physician. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group.
Measured: All exit-site infection episodes occurred last year in mupirocin group and all exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.
Rate of Infectious peritonitis in mupirocin compared with gentamicin group
Infectious peritonitis diagnosis by physicians. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
Measured: All infectious peritonitis episodes occurred last year in mupirocin group and all infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.
Secondary outcomes (5)
Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin group
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
Measured: All pathogenic organisms of exit-site infection episodes occurred last year in mupirocin group and all pathogenic organisms of exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.
Number and percentage Causative pathogens of Infectious peritonitis in mupirocin compared with gentamicin group
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
Measured: All pathogenic organisms of infectious peritonitis episodes occurred last year in mupirocin group and all pathogenic organisms of infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.
Percentage of catheter removal due to peritoneal dialysis-related infection
Prospective data collection from patient's medical records in gentamicin group
Measured: Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
Time to first peritoneal dialysis-related infection after gentamicin application
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group. Peritoneal-related infection diagnosis by physicians. Prospective data collection from patient's medical records in gentamicin group
Measured: Prospective period at least 1 year after entry to the study.
Drug susceptibility of causative pathogens of peritoneal dialysis-related infection
Drug susceptibility test by broth micro-dilution and E-test. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
Measured: Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Dec 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis-related InfectionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group: topical mupirocin ointment retrospective period compare with gentamicin prospective period
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Silpakorn University
- Responsible party
- Sponsor
- Investigators
- Ittaprach Yimsuk, PharmD, Study chair, College of Pharmacy, Rangsit universityPamila Tasanavipas, MD, Study director, Phramongkutklao hospital and College of MedicineDaraporn Rungprai, BCP, Study director, Faculty of Pharmacy, Silpakorn UniversityWichai Santimaleeworagun, BCP, Study director, Faculty of Pharmacy, Silpakorn UniversityKulthida Chaijumroen, B.N.S., Principal investigator, Phramongkutklao hospital and College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251584
- Sponsor's protocol ID
- PDRI-2021
- Status last verified
- Feb 2022
- First submitted
- 4 Jan 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection Caused by Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT05251584
- Acronym / sponsor ID
- PDRI-2021
- Conditions
- Peritoneal Dialysis-related Infection
- Keywords
- Peritoneal dialysis-related infection, Infectious peritonitis, Exit-site infection, Infection rate, Drug susceptibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Collaborators
- Silpakorn University
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 22 Feb 2022 (actual)
- 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.
Peritoneal dialysis-related infection is a complication that leads to peritoneal dialysis catheter removal or patient death. The present study aimed to investigate peritoneal dialysis-related infection, causative pathogens resulting in topical 2% mupirocin ointments period compare with 0.1% gentamicin cream period. Rate of catheter removal, time to first peritoneal dialysis-related infection after apply gentamicin cream.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group: topical mupirocin ointment retrospective period compare with gentamicin prospective period
| Arm | Type | Receives |
|---|---|---|
| Mupirocin and Gentamicin | Experimental | Drug: Mupirocin, Drug: Gentamicin2% mupirocin ointments apply at exit-site once daily after wound cleaning before recruit in the study then use 0.1% gentamicin cream apply at exit-site once daily after wound cleaning after entry to the study. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 20 years
- End stage renal disease patients on peritoneal dialysis follow up at Phramongkutklao hospital's peritoneal dialysis clinic between January 1, 2021 to March 31, 2023
- Start peritoneal dialysis or follow up at Phramongkutklao hospital's peritoneal dialysis clinic at least 90 days before recruited
- Use topical mupirocin ointment for prevention of peritoneal dialysis-related infection between January 1, 2021 to December 31, 2021
- Can be used LINE application throughout the study
Key exclusion criteria (6 listed)
- Allergy to gentamicin or components
- Previous systemic antibiotics use within 90 days before recruited
- Previous peritoneal dialysis-related infection within 28 days before recruited
- Immunosuppressants used
- Prospective follow up less than 2 months
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 |
|---|---|---|
| MupirocinAlso: BACIDALApply mupirocin ointments for prevention of peritoneal dialysis-related infection between 1 January 2021 to 31 December 2021 | Drug | Mupirocin and Gentamicin |
| GentamicinAlso: GENTREXApply gentamicin creams for prevention of peritoneal dialysis-related infection for 1 year start after 1 January 2022 | Drug | Mupirocin and Gentamicin |
Primary outcome
Rate of Exit-site infection in mupirocin compared with gentamicin group
Time frame: All exit-site infection episodes occurred last year in mupirocin group and all exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.
Exit-site infection diagnosis by physician. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group.
Rate of Infectious peritonitis in mupirocin compared with gentamicin group
Time frame: All infectious peritonitis episodes occurred last year in mupirocin group and all infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.
Infectious peritonitis diagnosis by physicians. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
5 secondary outcomes
Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin group
Time frame: All pathogenic organisms of exit-site infection episodes occurred last year in mupirocin group and all pathogenic organisms of exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.
Number and percentage Causative pathogens of Infectious peritonitis in mupirocin compared with gentamicin group
Time frame: All pathogenic organisms of infectious peritonitis episodes occurred last year in mupirocin group and all pathogenic organisms of infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.
Percentage of catheter removal due to peritoneal dialysis-related infection
Time frame: Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
Time to first peritoneal dialysis-related infection after gentamicin application
Time frame: Prospective period at least 1 year after entry to the study.
Drug susceptibility of causative pathogens of peritoneal dialysis-related infection
Time frame: Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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.
Ittaprach Yimsuk, PharmD study chair
College of Pharmacy, Rangsit university
Pamila Tasanavipas, MD study director
Phramongkutklao hospital and College of Medicine
Daraporn Rungprai, BCP study director
Faculty of Pharmacy, Silpakorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mupirocin and Gentamicin in people with Peritoneal Dialysis-related Infection, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
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 5 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. 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 Thailand. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ittaprach Yimsuk, PharmD (097-237-4797, ittaprach.y@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Exit-site infection in mupirocin compared with gentamicin group (time frame: All exit-site infection episodes occurred last year in mupirocin group and all exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.). 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 22 Feb 2022.