End Stage Renal DiseasePhase 4COSMO-PDNCT02547103
Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection
A Phase 4 study testing Chlorhexidine gluconate-soaked cloths, Normal saline and mupirocin ointment in people with End Stage Renal Disease and Peritoneal Dialysis, run by Chiang Mai University at 1 site in Thailand.
Trial summary
This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline) with aseptic technique in prevention of PD-related infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Peritoneal Dialysis
- What is being tested?
- Chlorhexidine gluconate-soaked cloths, Normal saline and mupirocin ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2016to Aug 2021
- 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
- 1. Patients with end-stage renal disease who were undergoing peritoneal dialysis; either continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD)
Who cannot join
- History of psychological illness or condition that interferes with the ability to understand or comply with the requirements of the study
- Recent (within 1 month) exit-site or tunnel infection, or peritonitis
- Known hypersensitivity to, or intolerance of, chlorhexidine gluconate, or mupirocin
- Current or recent (within 1 month) treatment with antibiotics administered by any route
- Nasal carriage of mupirocin-resistant Staphylococcus aureus or chlorhexidine-resistant S. aureus
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Kajohnsak Noppakun, Nephrologist, +6653946452, knoppaku@med.cmu.ac.th
Chayutthaphong Chaisai, Pharmacist, +6653941507, c.chayutthaphong@gmail.com
About this study
Official title: Efficacy and Safety of Local Application of Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection: A Double-Blind, Stratified Randomized Controlled Trial
This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline) with aseptic technique in prevention of PD-related infection. It is a multicenter, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be followed up 24 months or completion of PD. The primary outcome is PD-related infection (PD-related peritonitis of exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related quality of life, mental health, medication adherence, safety, adverse events related to treatments such as skin irritation, rash, etc. Costs include providers and patients expenses. The utility is assessed using the EuroQol (EQ), five-dimensional (5D), five-level (5L) version. The results of this study are anticipated nephrologists and health care professional involving to PD in decision-making for a plan to prevent PD-related infection. In addition, the results will lead to clinical guideline development a prevention of PD-related infection.
Read the detailed description
Peritoneal dialysis (PD) is one of renal replacement therapy used for end-stage renal disease. Since 2011, there has been increasing numbers of patients under "PD First" policy of the Thai government. The most common PD related complication is PD-related infection categorized PD-related peritonitis, and exit site and tunnel infection. Although possible to treat PD-related infection, the incidence of technical failure and death due to peritonitis are still high in Thailand. PD-related infections mainly caused by Staphylococcus aureus. To prevent PD-related infection, cleaning with aseptic solvents using aseptic technique and prevent infection by prescribing prophylactic antibiotics are recommended. The International Society for Peritoneal Dialysis (ISPD) has recommended position statement of the regular use of mupirocin ointment around the catheter exits point and apply in nasal cavity. However, there is rising concern of long term use of mupirocin for mupirocin resistance of S. aureus. CHG is antiseptic use in clinical practice. It can coat at least 12 hours on skin and has anti-bacterial covered in both grams negative and positive. Several meta-analysis studies showed effectiveness of CHG in the prevention of hospitals infection i.e. reduces catheter-related sepsis, postoperative infection, and microbial resistance. According to PD-related infection, CHG has very little evidence of its effectiveness. This pilot study aims to evaluate effectiveness, safety, and cost-utility of CHG-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline and povidone-iodine) with aseptic technique in prevention of PD-related infections. It is a multicenter, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths. They will be followed up 24 months or completetion of PD. The primary outcome is PD-related infection (PD-related peritonitis or exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related quality of life, mental health, medication adherence, safety, adverse events related to treatments such as skin irritation, rash, etc. For cost-utility analysis, costs include providers and patients expenses. The Utility is assessed using EQ-5D-5L.
- Conditions
- End Stage Renal Disease, Peritoneal Dialysis
- Being tested
- Chlorhexidine gluconate-soaked cloths, Normal saline, mupirocin ointment
- Keywords
- Chlorhexidine gluconate, Mupirocin ointment, Normal saline, Peritonitis, Peritoneal dialysis
- Medical subject headings
- Kidney Failure, Chronic, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconate-soaked clothsOther
Normal salineOther
mupirocin ointmentOther
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine gluconate | Experimental | Chlorhexidine gluconate-soaked cloths, clean topical area around catheter exit site with CHG 2% soaked cloths Receives: Other: Chlorhexidine gluconate-soaked cloths |
| Normal saline (usual care) | Active comparator | Normal saline, clean topical area around catheter exit site Receives: Other: Normal saline |
| Mupirocin ointment | Active comparator | Mupirocin ointment 2%, clean topical area around catheter exit site with Mupirocin ointment Receives: Other: mupirocin ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PD-related infections
Peritonitis or exit-site and tunnel infection
Measured: 24 months
Secondary outcomes (10)
Incidence of infection-related catheter removal
Peritonitis or exit-site and tunnel infection-related catheter removal
Measured: 24 months
Incidence of hospitalization due to PD-related infection
Measured: 24 months
Incidence of PD technical failure (change of modal of dialysis)
change of modal of dialysis
Measured: 24 months
Incidence of death due to PD-related infection
Death due to peritonitis or exit-site and tunnel infection
Measured: 24 months
Rate of Staphylococcus aureus colonization
Incidence of nasal or exit-site S. aureus colonization
Measured: 24 months
Changes in health-related quality of life
Using the Kidney Disease Quality of Life-36 (KDQOL-36), EuroQoL-5 dimension-5 level (EQ-5D-5L)
Measured: 24 months
Number of participants with depression
Using the Beck Depression Inventory II (BDI-II)
Measured: 24 months
Changes in medication adherence
Using (i) directly observed to record the use of investigational medicinal products via return plastic sachets and ointment tubes; (ii) global rating on medication adherence by visual analog scale; and (iii) Medication-taking behavior measure for Thai patients (MTB-Thai questionnaire
Measured: 24 months
Total healthcare costs
Direct medical costs, direct non-medical costs, and indirect costs
Measured: 24 months
Incidence of skin reactions
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start1 Jun 2016
- Primary completion30 Jun 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand
- Responsible party
- Principal investigator, Chidchanok Ruengorn, Chiang Mai University
- Investigators
- Chidchanok Ruengorn, Study director, Faculty of Pharmacy CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547103
- Sponsor's protocol ID
- THOR-PD Group
- Acronym
- COSMO-PD
- Status last verified
- Jul 2019
- First submitted
- 7 Sep 2015
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nochaiwong S, Ruengorn C, Noppakun K, Panyathong S, Dandecha P, Sood MM, Saenjum C, Awiphan R, Sirilun S, Mongkhon P, Chongruksut W, Thavorn K; Thai Renal Outcomes Research (THOR) Investigators. Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol. Trials. 2019 Dec 19;20(1):754. doi: 10.1186/s13063-019-3953-8.
PubMed 31856900
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Local Application of Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection: A Double-Blind, Stratified Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02547103
- Acronym / sponsor ID
- COSMO-PD / THOR-PD Group
- Conditions
- End Stage Renal Disease, Peritoneal Dialysis
- Keywords
- Chlorhexidine gluconate, Mupirocin ointment, Normal saline, Peritonitis, Peritoneal dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 11 Sep 2015 (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 pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline) with aseptic technique in prevention of PD-related infection. It is a multicenter, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be followed up 24 months or completion of PD. The primary outcome is PD-related infection (PD-related peritonitis of exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related quality of life, mental health, medication adherence, safety, adverse events related to treatments such as skin irritation, rash, etc. Costs include providers and patients expenses. The utility is assessed using the EuroQol (EQ), five-dimensional (5D), five-level (5L) version. The results of this study are anticipated nephrologists and health care professional involving to PD in decision-making for a plan to prevent PD-related infection. In addition, the results will lead to clinical guideline development a prevention of PD-related infection.
Detailed description
Peritoneal dialysis (PD) is one of renal replacement therapy used for end-stage renal disease. Since 2011, there has been increasing numbers of patients under "PD First" policy of the Thai government. The most common PD related complication is PD-related infection categorized PD-related peritonitis, and exit site and tunnel infection. Although possible to treat PD-related infection, the incidence of technical failure and death due to peritonitis are still high in Thailand. PD-related infections mainly caused by Staphylococcus aureus. To prevent PD-related infection, cleaning with aseptic solvents using aseptic technique and prevent infection by prescribing prophylactic antibiotics are recommended. The International Society for Peritoneal Dialysis (ISPD) has recommended position statement of the regular use of mupirocin ointment around the catheter exits point and apply in nasal cavity. However, there is rising concern of long term use of mupirocin for mupirocin resistance of S. aureus. CHG is antiseptic use in clinical practice. It can coat at least 12 hours on skin and has anti-bacterial covered in both grams negative and positive. Several meta-analysis studies showed effectiveness of CHG in the prevention of hospitals infection i.e. reduces catheter-related sepsis, postoperative infection, and microbial resistance. According to PD-related infection, CHG has very little evidence of its effectiveness. This pilot study aims to evaluate effectiveness, safety, and cost-utility of CHG-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline and povidone-iodine) with aseptic technique in prevention of PD-related infections. It is a multicenter, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths. They will be followed up 24 months or completetion of PD. The primary outcome is PD-related infection (PD-related peritonitis or exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related quality of life, mental health, medication adherence, safety, adverse events related to treatments such as skin irritation, rash, etc. For cost-utility analysis, costs include providers and patients expenses. The Utility is assessed using EQ-5D-5L.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine gluconate | Experimental | Other: Chlorhexidine gluconate-soaked clothsChlorhexidine gluconate-soaked cloths, clean topical area around catheter exit site with CHG 2% soaked cloths |
| Normal saline (usual care) | Active comparator | Other: Normal salineNormal saline, clean topical area around catheter exit site |
| Mupirocin ointment | Active comparator | Other: mupirocin ointmentMupirocin ointment 2%, clean topical area around catheter exit site with Mupirocin ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients with end-stage renal disease who were undergoing peritoneal dialysis; either continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD)
Key exclusion criteria (5 listed)
- History of psychological illness or condition that interferes with the ability to understand or comply with the requirements of the study
- Recent (within 1 month) exit-site or tunnel infection, or peritonitis
- Known hypersensitivity to, or intolerance of, chlorhexidine gluconate, or mupirocin
- Current or recent (within 1 month) treatment with antibiotics administered by any route
- Nasal carriage of mupirocin-resistant Staphylococcus aureus or chlorhexidine-resistant S. aureus
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 |
|---|---|---|
| Chlorhexidine gluconate-soaked cloths | Other | Chlorhexidine gluconate |
| Normal saline | Other | Normal saline (usual care) |
| mupirocin ointment | Other | Mupirocin ointment |
Primary outcome
Incidence of PD-related infections
Time frame: 24 months
Peritonitis or exit-site and tunnel infection
10 secondary outcomes
Incidence of infection-related catheter removal
Time frame: 24 months
Incidence of hospitalization due to PD-related infection
Time frame: 24 months
Incidence of PD technical failure (change of modal of dialysis)
Time frame: 24 months
Incidence of death due to PD-related infection
Time frame: 24 months
Rate of Staphylococcus aureus colonization
Time frame: 24 months
Changes in health-related quality of life
Time frame: 24 months
Number of participants with depression
Time frame: 24 months
Changes in medication adherence
Time frame: 24 months
Total healthcare costs
Time frame: 24 months
Incidence of skin reactions
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Derived from this study: PubMed 31856900Nochaiwong S, Ruengorn C, Noppakun K, Panyathong S, Dandecha P, Sood MM, Saenjum C, Awiphan R, Sirilun S, Mongkhon P, Chongruksut W, Thavorn K; Thai Renal Outcomes Research (THOR) Investigators. Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol. Trials. 2019 Dec 19;20(1):754. doi: 10.1186/s13063-019-3953-8.
- Faculty of Pharmacy, Chiang Mai UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Chidchanok Ruengorn study director
Faculty of Pharmacy CMU
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 Chlorhexidine gluconate-soaked cloths, Normal saline and mupirocin ointment in people with End Stage Renal Disease and Peritoneal Dialysis, run by Chiang Mai University 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 1 inclusion and 5 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 29 Jul 2019. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Surapon Nochaiwong (+6653991507, surapon.nochaiwong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PD-related infections (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02547103, which also lists 1 linked publication.
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 29 Jul 2019.